IVA Inventiva S.A.

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Upcoming Catalysts

Drug Stage Catalyst Date
Lanifibranor
Nonalcoholic fatty liver disease (NAFLD)
Phase 2
Phase 2
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Lanifibranor (NATiV3)
Nonalcoholic steatohepatitis (NASH)
Phase 3
Phase 3
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Drug Pipeline

Drug Stage Notes
Cedirogant (ABBV-157)
Psoriasis
Phase 2b
Phase 2b
Phase 2b trial to be initiated November 2021 and to complete March 2023.
Odiparcil
MPS VI
Phase 1/2
Phase 1/2
MPS- related R&D remains on hold, strategic update expected in 2022, September 20, 2022.

Latest News

    • In the Phase IIb NATIVE, lanifibranor met both the primary and key secondary endpoints, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASH
    • NATIVE was the first clinical trial demonstrating an effect on the composite histology endpoint of NASH resolution and improvement of fibrosis
    • NATiV31, a pivotal phase III trial of lanifibranor in NASH is currently ongoing with first clinical trial sites initiated and patients screened in the United States and if topline results, expected H2 2024, are positive, intent is to seek U.S. accelerated approval and EU conditional approval

    Daix (France), Long Island City (New York, United States), October 20, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage…

    • In the Phase IIb NATIVE, lanifibranor met both the primary and key secondary endpoints, including NASH resolution with no worsening of fibrosis and improvement of liver fibrosis with no worsening of NASH
    • NATIVE was the first clinical trial demonstrating an effect on the composite histology endpoint of NASH resolution and improvement of fibrosis
    • NATiV31, a pivotal phase III trial of lanifibranor in NASH is currently ongoing with first clinical trial sites initiated and patients screened in the United States and if topline results, expected H2 2024, are positive, intent is to seek U.S. accelerated approval and EU conditional approval

    Daix (France), Long Island City (New York, United States), October 20, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced the publication of the results from its NATIVE (NAsh Trial to Validate IVA337 Efficacy) Phase IIb clinical trial evaluating lanifibranor for the treatment of NASH in the prestigious, peer-reviewed medical journal The New England Journal of Medicine (NEJM).

    In the 24-week clinical trial, lanifibranor, an orally-available small molecule and the only pan-PPAR agonist currently in clinical development for the treatment of NASH, at 1200mg/day met the primary endpoint with a statistically significant reduction of the Steatosis Activity Fibrosis score (SAF), which combines assessments of hepatocellular inflammation and ballooning, with no worsening of fibrosis in the Intention To Treat (ITT2) and the Per Protocol populations (PP3).

    Lanifibranor also met key secondary endpoints, including NASH resolution with no worsening of fibrosis4 and improvement of liver fibrosis with no worsening of NASH5 in both ITT and PP populations, as well as the composite endpoint of NASH resolution and improvement of liver fibrosis. With these latter results, lanifibranor is the first orally available drug candidate to achieve statistically significant results on the two U.S. Food and Drug Administration (FDA) and European Medicine Agency (EMA) primary endpoints relevant for seeking U.S. accelerated approval and EU conditional approval during Phase III clinical development.

    The results of NATIVE were reported in June 2020 in accordance with the study protocol and Statistical Analysis Plan design using a single imputation method of missing data, a conservative method that consider missing end-of-study biopsy data as non-responders. The data presented in The New England Journal of Medicine showed additional analyses presented in accordance with the journal requirements using a multiple imputation method of missing end-of-study biopsy data.

    The different statistical methods lead to similar results as shown in the table below, confirming the robustness of NATIVE results.

      Primary and main secondary endpoints

    Intention to Treat Population (ITT)
    Single Imputation Method Multiple Imputation Method
    Placebo

    (N = 81)
    Lanifibranor Placebo

    (N = 81)
    Lanifibranor
    800mg

    (N = 83)
    1200mg

    (N = 83)
    800mg

    (N = 83)
    1200mg

    (N = 83)
    Primary

    endpoint
    Decrease of ≥2 points of SAF activity score(1) 27% 41% 49% 33% 48% 55%
    Risk Ratio [95%Cl](5)   1.52

    [0.98-2.12]

    P=0.061
    1.82

    [1.24-2.40]

    P=0.004
      1.45

    [1.00-2.10]

    P=0.073
    1.69

    [1.22-2.34]

    P=0.007
    Secondary endpoints Resolution of NASH and no worsening of fibrosis (2) 19% 33% 45% 22% 39% 49%
    Risk Ratio [95%Cl] (5)(6)   1.75

    [1.02-2.68]

    P=0.043
    2.41

    [1.53-3.35]

    P<0.001
      1.70

    [1.07-2.71]

    P=0.039
    2.20

    [1.49-3.26]

    P<0.001
    Improvement of fibrosis by at least one stage and no worsening of NASH (3) 24% 28% 42% 29% 34% 48%
    Risk Ratio [95%Cl] (5)(6)   1.18

    [0.68-1.86]

    P=0.530
    1.80

    [1.16-2.51]

    P=0.011
      1.15

    [0.72-1.85]

    P=0.561
    1.68

    [1.15-2.46]

    P=0.017
    Resolution of NASH and improvement of fibrosis (4) 7% 21% 31% 9% 25% 35%
      Risk Ratio [95%Cl] (5)(6)   2.71

    [1.16-5.40]

    P=0.017
    4.25

    [2.02-7.37]

    P<0.001
      2.57

    [1.2-5.51]

    P=0.018
    3.95

    [2.03-7.66]

    P<0.001

    (1). Response is defined as a decrease from baseline to week 24 of at least 2 points of the SAF Activity score (SAF-A) with no worsening of the CRN Fibrosis score (CRN-F). No worsening means that score remains stable or decreases.

    (2). Resolution of NASH with no worsening of fibrosis at week 24: CRN-I = 0 or 1 (CRN-Inflammation), CRN-B = 0 (CRN-Ballooning) and no worsening of CRN-F from baseline.

    (3). Improvement of liver fibrosis ≥ 1 stage and no worsening of NASH at week 24: Improvement of CRN-F ≥ 1 stage and no increase of CRN-S, CRN-I or CRN-B.

    (4). Resolution of NASH and improvement of fibrosis at week 24: CRN-I = 0 or 1, CRN-B = 0 and an improvement of CRN-F ≥ 1 stage.

    (5). Risk ratio was calculated using the Cochran–Mantel–Haenszel method stratified by diabetic status at baseline, and can be interpreted as the ratio of % responders in lanifibranor to % responders in placebo.

    (6). As per recommendations of the New England Journal of Medicine, p values were not included on secondary endpoints and will not appear in the publication.

    Throughout the Company's NATIVE Phase IIb clinical trial, lanifibranor also showed an overall favorable tolerability profile, consistent with observations from previous clinical studies. The drop-out rates for adverse events  were 3.6% in 1200mg, 4.8% in 800mg, and 3.7% in placebo, with  the vast majority being mild or moderate in intensity. The rate of severe treatment-emergent adverse events (TEAE) was similar in the three arms (<4%) and two serious TEAEs were assessed as drug-related (mild heart failure; urticaria), both occurring in the placebo group.

    The Native phase IIb results contributed in obtaining FDA Breakthrough Therapy designation in NASH in 2020 and allowed Inventiva to start a pivotal phase III trial which is currently ongoing following the activation of first clinical sites and start of patient screening in the United States in September 2021.. Topline results of this study are expected H2 2024 and, if positive, should allow us to seek U.S. accelerated approval and EU conditional approval.

    Pierre Broqua, Chief Scientist Officer and cofounder of Inventiva, commented: "We are delighted to see the results of our NATIVE Phase IIb clinical trial in NASH published in the renowned and influential The New England Journal of Medicine, which reflects the clinical significance and scientific rigor of our lanifibranor development program.  Backed by these strong Phase IIb results and following the recent initiation of the Phase III clinical trial, we are convinced that lanifibranor, with its unique characteristics as a pan-PPAR agonist, is ideally positioned in the NASH field and we now look forward to advancing with its pivotal development phase."

    Prof. Sven Francque, M.D., Ph.D., Antwerp University Hospital and co-principal investigator of the Phase IIb NATIVE clinical trial, said: "The publication of the results of the Phase IIb NATIVE in The New England Journal of Medicine is an important scientific accomplishment and represents a milestone for the patients who have committed to this trial and those waiting for a treatment. The Inventiva team and all the investigators, including myself, are deeply grateful for all the patients who have participated to NATIVE and the ones who will be participating in NATiV3. This publication is a major contribution to the field of NASH."

    Prof. Manal Abdelmalek, M.D., M.P.H., Duke University and co-principal investigator of the Phase IIb NATIVE clinical trial, added: "It is important when considering treatment strategy to have a therapeutic available that will target not only NASH but also fibrosis, the primary predictor of mortality in patients with NASH. NATIVE was the first phase IIb to meet the composite histology endpoint of NASH resolution and fibrosis improvement, achieving both FDA and EMA regulatory endpoints. While a modest increase in body weight was observed during the trial, patients receiving  lanifibranor were metabolically healthy and had better lipids and glycemic profiles which are key for cardiovascular risk reduction in patients at increased risk of cardiovascular disease . The Phase IIb data certainly give us great optimism and enthusiasm for NATiV3, the phase III clinical trial."

    Jean-Louis Junien, Chairman of Inventiva's Scientific Advisory Board, commented: "This article translates the expertise and deep understanding of the Inventiva team of the mechanism of actions of nuclear receptors, and more specifically of PPARs, which associated with their strong experience in biology, chemistry and pharmacology has allowed Inventiva to develop lanifibranor."

    Publication details

    Publication title: "A Randomized Controlled Trial of the panPPAR agonist lanifibranor in NASH"
    Date of publication: October 21, 2021
    Authors: Sven M. Francque, Pierre Bedossa, Vlad Ratziu, Quentin M. Anstee, Elisabetta Bugianesi, Arun J. Sanyal, Rohit Loomba, Stephen A. Harrison, Rozalina Balabanska, Lyudmila Mateva, Nicolas Lanthier, Naim Alkhouri, Christophe Moreno, Jörn M. Schattenberg, Diana Stefanova-Petrova, Luisa Vonghia, Régine Rouzier, Maeva Guillaume, Alexander Hodge, Manuel Romero-Gómez, Philippe Huot-Marchand, Martine Baudin, Marie-Paule Richard, Jean-Louis Abitbol, Pierre Broqua, Jean-Louis Junien, Manal F. Abdelmalek.
    Online version: http://www.nejm.org/doi/full/10.1056/NEJMoa2036205



     
    Print edition: October 21, 2021 vol. 385 no. 17

    About lanifibranor

    Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development. Inventiva believes that lanifibranor's moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.

    About NASH

    Nonalcoholic steatohepatitis (NASH) is a serious liver disease characterized by excessive fat accumulation in the liver, chronic inflammation and tissue injury (hepatitis), resulting in progressive fibrosis that can lead to cirrhosis, and subsequently portal hypertension, liver insufficiency and potential liver cancer. The prevalence of NASH is rapidly increasing globally in parallel with the growing epidemics of obesity and type 2 diabetes; correspondingly, the proportion and number of liver transplants attributable to NASH has expand continuously in past years. To date, there are still no drug therapies approved for the treatment of NASH.

    About the NATIVE Phase IIb trial

    The NATIVE (NAsh Trial to Validate IVA337 Efficacy) clinical trial was a 24-week randomized, double-blind, placebo-controlled Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH. The main purpose of the trial was to assess the efficacy of lanifibranor in improving liver inflammation and ballooning, the two histological markers included in the definition of the regulatory endpoint of NASH resolution. To be considered for inclusion, patients were required to have: a diagnosis of NASH confirmed by liver biopsy; a cumulative score of inflammation and ballooning (as measured using the SAF scoring system) of three or four out of four, indicating the presence of moderate to severe inflammation and ballooning; a steatosis score greater than or equal to one, indicating the presence of moderate to severe steatosis; and a fibrosis score less than four, indicating the absence of cirrhosis. The primary endpoint of the trial was a reduction in the combined inflammation and ballooning score of two points compared to baseline, with no worsening fibrosis, as measured by the SAF score. Secondary endpoints included NASH resolution, improvements in each of the steatosis, inflammation, ballooning and fibrosis scores from baseline as measured using the SAF score, improvements in various other fibrosis measures, improvements in several metabolic markers, improvements in steatosis, inflammation and ballooning as measured using the NAS score (NAFLD activity score), and safety.

    The trial randomized 247 patients with NASH in 71 sites in Australia, Canada, Europe, Mauritius and the United States.

    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of earlier stage programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. Inventiva recently announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients at the end of 2019 and received FDA Fast Track designation in MPS VI for odiparcil in October 2020.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (OTC:IVEVF) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com

    Contacts

    Inventiva

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
         

    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, with respect to the anticipated timeline for seeking of regulatory approvals for candidates, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 202, Amendment No. 1 to our Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 24, 2021, as well as the full-year financial report for the year ended December 31, 2020 for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.



     

    1 For more details, please refer to: clinicaltrial.gov/NCT04849728

    2 ITT: includes all patients randomized in the trial.

    3 PP: includes all patients with paired biopsies and without deviation impacting efficacy assessment.

    4 NASH resolution and no worsening of fibrosis defined as CRN Lobular inflammation score equal to 0 or 1 and CRN Hepatocyte ballooning score equal to 0 and no worsening of the CRN-Fibrosis score.

    5 Improvement of liver fibrosis with no worsening of NASH defined as improvement of CRN-Fibrosis score ≥ 1 stage and no increase of CRN-Steatosis score and no increase of CRN-Inflammation score and no increase of CRN-Ballooning score.





     

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    • Four poster presentations add to the evidence of the beneficial effects of lanifibranor therapy on key components of NASH, following further sub-analyses of Inventiva's NATIVE Phase IIb clinical trial results
    • The fifth poster presentation demonstrates that lanifibranor improves NASH, fibrosis and diastolic dysfunction in a hamster model of diet-induced NASH and diastolic dysfunction

    Daix (France), Long Island City (New York, United States), October 18, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced…

    • Four poster presentations add to the evidence of the beneficial effects of lanifibranor therapy on key components of NASH, following further sub-analyses of Inventiva's NATIVE Phase IIb clinical trial results
    • The fifth poster presentation demonstrates that lanifibranor improves NASH, fibrosis and diastolic dysfunction in a hamster model of diet-induced NASH and diastolic dysfunction

    Daix (France), Long Island City (New York, United States), October 18, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical needs, today announced that five scientific abstracts have been selected for poster presentations during the upcoming The Liver Meeting™ 2021, organized by the American Association for the Study of Liver Diseases (AASLD) on November 12-15, 2021.

    The first abstract focuses on the improvement of insulin resistance and the reversal to normoglycemia in patients with non-cirrhotic NASH and prediabetes treated with lanifibranor. Prediabetes, defined by fasting glucose levels, is a risk factor for cardiovascular disease (CVD). Based on Inventiva's NATIVE Phase IIb clinical trial evaluating lanifibranor in NASH, the authors show that markers of glucose metabolism improved in patients with non-cirrhotic NASH and prediabetes during treatment with lanifibranor.

    The second abstract demonstrates the beneficial effect of lanifibranor on the reduction of hepatic steatosis and shows a correlation with markers of lipid and glucose metabolism. The authors explain that, during the NATIVE Phase IIb clinical trial, lanifibranor therapy induced a decrease of steatosis, as measured by the Controlled Attenuation Parameter (CAP, Fibroscan) method, consistent with the decrease of steatosis observed with histological grading.

    The third abstract highlights the correlation between NASH resolution and fibrosis improvement following lanifibranor treatment. The results from the NATIVE Phase IIb clinical trial show that, following treatment at both doses of lanifibranor (800mg/daily and 1200mg/daily), NASH resolution responders were significantly more likely to also be fibrosis improvers. Such correlation was also observed between ballooning improvement and fibrosis improvement.

    The fourth abstract focuses on the positive effect of lanifibranor therapy in reducing Liver Sinusoidal Endothelial Cell (LSEC) capillarization. Based on the results of the NATIVE Phase IIb clinical trial, the authors analysed the change in capillarization (measured by CD34 immunostaining) of LSEC in patients with NASH and an activity >3 according to the Steatosis Activity Fibrosis (SAF) score1. CD34 staining increased with inflammation grade and fibrosis progression. Lanifibranor showed a dose dependent reduction of CD34 staining which reached significance in the periportal area.

    The fifth abstract demonstrates that lanifibranor improves NASH, fibrosis and diastolic dysfunction in a hamster model of diet-induced NASH and diastolic dysfunction. In a non-clinical study conducted in a hamster model of NASH and diastolic dysfunction induced by a diet rich in fat, cholesterol and fructose, the authors evaluated the effect of pan-PPAR agonist lanifibranor. The results show that lanifibranor significantly reduced lipids metabolism markers and reversed steatosis, inflammation and fibrosis while significantly improving diastolic dysfunction. This new data further supports the potential development of lanifibranor as a treatment for NASH patients with high risk of cardiovascular diseases.

    These abstracts will be available for viewing by attendees on the AASLD website and will also be featured in the October supplement of the scientific journal Hepatology.

    The details of the five poster presentations are as follows:

    Abstract #1:

    Abstract title: "Lanifibranor reverses fasting glucose levels to normoglycemia in prediabetic patients with nonalcoholic steatohepatitis (NASH)"
    Publication number: 1920
    Session title: NAFLD and NASH: Therapeutics - Pharmacologic and Other
    Author: Dr. Michael Cooreman, Chief Medical Officer of Inventiva

    Abstract #2:

    Abstract title: "Lanifibranor treatment improves hepatic steatosis in patients with NASH, evaluated by histological grading and Controlled Attenuation Parameter (CAP)"
    Publication number: 1921
    Session title: NAFLD and NASH: Therapeutics - Pharmacologic and Other
    Author: Dr. Michael Cooreman, Chief Medical Officer of Inventiva

    Abstract #3:

    Abstract title: "Treatment response to the PAN-PPAR agonist lanifibranor in the NATIVE study: NASH resolution and fibrosis improvement are correlated"
    Publication number: 1938
    Session title: NAFLD and NASH: Therapeutics - Pharmacologic and Other
    Author: Prof. Arun Sanyal, M.D., Virginia Commonwealth University and co-principal investigator of Inventiva's NATiV3 Phase III clinical trial

    Abstract #4:

    Abstract title: "Liver Sinusoidal Endothelial Cell (LSEC) capillarization in NASH and its evolution following lanifibranor treatment: an exploratory study of the NATIVE clinical trial"
    Publication number: 1874
    Session title: NAFLD and NASH: Experimental: Clinical
    Author: Prof. Pierre-Emmanuel Rautou, MD, PhD, Hopital Beaujon

    Abstract #5:

    Abstract title: "Lanifibranor improves NASH, fibrosis and diastolic dysfunction in a hamster preclinical model of diet induced NASH"
    Publication number: 1919
    Session title: NAFLD and NASH: Therapeutics - Pharmacologic and Other
    Presentation type: Poster presentation
    Author: Guillaume Wettstein, Head of Pharmacology of Inventiva



    About the American Association for the Study of Liver Diseases (AASLD)2

    AASLD is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. We advance the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.

    About lanifibranor

    Lanifibranor, Inventiva's lead product candidate, is an orally-available small molecule that acts to induce anti-fibrotic, anti-inflammatory and beneficial vascular and metabolic changes in the body by activating all three peroxisome proliferator‑activated receptor (PPAR) isoforms, which are well‑characterized nuclear receptor proteins that regulate gene expression. Lanifibranor is a PPAR agonist that is designed to target all three PPAR isoforms in a moderately potent manner, with a well‑balanced activation of PPARα and PPARδ, and a partial activation of PPARγ. While there are other PPAR agonists that target only one or two PPAR isoforms for activation, lanifibranor is the only pan‑PPAR agonist in clinical development for the treatment of NASH. Inventiva believes that lanifibranor's moderate and balanced pan‑PPAR binding profile contributes to the favorable tolerability profile that has been observed in clinical trials and pre‑clinical studies to date. The FDA has granted Breakthrough Therapy and Fast Track designation to lanifibranor for the treatment of NASH.

    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of preclinical programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients in 2019 and received both FDA Fast Track and Rare Paediatric Disease designation for odiparcil in MPS VI.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (OTC:IVEVF) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com.

    Contacts

    Inventiva

    Pascaline Clerc

    VP of Global External Affairs



    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank



    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
         

    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical trial data releases, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to pipeline product candidates that the clinical trial results will be available on their anticipated timeline, that future clinical trials will be initiated as anticipated, or that candidates will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021 as well as the half-year financial report for the six months ended June 30, 2021 for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.







     

    1 The SAF score combines assessments of hepatocellular inflammation and ballooning.





     

    2 https://www.aasld.org/





     

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  1. Daix (France), Long Island City (New York, United States), September 28, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the Company's leadership will participate in three upcoming investor conferences in October 2021.

    The event details are as follows:

    Daix (France), Long Island City (New York, United States), September 28, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the Company's leadership will participate in three upcoming investor conferences in October 2021.

    The event details are as follows:

    Conference n°1:              HealthTech Innovation Days 2021

    Event type:                       One-on-one investor meetings

    Date:                                  Monday-Tuesday, October 4-5, 2021

    Time:                                  3:00 am – 12:00 pm (ET) / 9:00 am – 6:00 pm (CET)

    Format:                              Hybrid event

    Conference n°2:              Portzamparc Health Biotech Seminar

    Event type:                       One-on-one investor meetings

    Date:                                   Wednesday, October 6, 2021

    Time:                                  3:00 am – 12:15 pm (ET) / 9:00 am – 6:15 pm (CET)

    Format:                              Hybrid event

    Conference n°3:              H.C. Wainwright 5th Annual NASH Investor Conference

    Event type:                       Corporate presentation, one-on-one investor meetings

    Date:                                   Monday, October 11, 2021

    Time:                                  2:00 am – 12:00 pm (ET) / 8:00 am – 6:00 pm (CET)

    Format:                              Virtual event

    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of preclinical programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients in 2019 and received both FDA Fast Track and Rare Paediatric Disease designation for odiparcil in MPS VI.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (OTC:IVEVF) and on the Nasdaq Global Market in the United States (ticker: IVA). www.inventivapharma.com.

    Contacts

         



    Inventiva



    Pascaline Clerc

    VP Global External Affairs

    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Relations médias

    inventiva@brunswickgroup.com



    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank

    Relations investisseurs

    patti.bank@westwicke.com



    +1 415 513-1284

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    • Sale performed at a price of $14.40 per new ADS1 , without a discount  to the volume weighted average price of the Company's ADS over the last trading day

    Daix (France), Long Island City (New York, United States), September 23, 2021 – Inventiva (NASDAQ:IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that it has completed sales of 2,083,334 of American Depositary Shares ("ADS") pursuant to the Company's ATM program established on August…

    • Sale performed at a price of $14.40 per new ADS1 , without a discount  to the volume weighted average price of the Company's ADS over the last trading day

    Daix (France), Long Island City (New York, United States), September 23, 2021 – Inventiva (NASDAQ:IVA) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need in the areas of fibrosis, lysosomal storage disorders and oncology, today announced that it has completed sales of 2,083,334 of American Depositary Shares ("ADS") pursuant to the Company's ATM program established on August 2, 2021 (the "ATM Sales"), through Jefferies LLC ("Jefferies"), acting as sales agent. Each ADS represents one ordinary share of the Company.

    In the ATM Sales, an aggregate of 2,083,334 new ADSs and the same number of underlying new ordinary shares (the "New Shares") have been issued to existing and new specialized institutional investors through a capital increase without shareholders' preferential subscription rights under the provisions of Article L. 225-138 of the French Commercial Code (Code de commerce) and pursuant to the 20th resolution adopted by the annual general meeting of shareholders held on April 16, 2021 at a price of $14.40 per new ADS, without a discount to the volume weighted average price of the Company's ADS over the last trading day and representing a discount of 3% to the volume weighted average price of the Company's ordinary shares on the regulated market of Euronext in Paris ("Euronext") over the last trading day (i.e., 12.66 euros) (based on today's U.S. dollar euro exchange rate, as published by the European Central Bank). The New Shares will represent 5.1% of the share capital of the Company upon completion of the transaction.

    It is anticipated that the settlement and delivery of the New Shares will take place on September 27, 2021. They will be admitted to trading on Euronext and the issued ADSs will trade on Nasdaq.

    A shelf registration statement on Form F-3, including a base prospectus relating to Inventiva's securities and a sales agreement prospectus relating to the ATM program, was filed with the SEC on August 2, 2021 and became effective on August 6, 2021. Prospective investors should read the base prospectus and the accompanying sales agreement prospectus, together with the documents incorporated by reference therein. Prospective investors may obtain these documents for free by visiting EDGAR on the SEC's website at www.sec.gov. Alternatively, a copy of the base prospectus supplement and accompanying sales agreement prospectus relating to the offering may be obtained from Jefferies LLC, 520 Madison Avenue, New York, NY 10022 or by telephone at (877) 821 - 7388 or by email at Prospectus_Department@Jefferies.com.

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. In particular, no public offering of the ADSs will be made in Europe.

    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of preclinical programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients in 2019 and received both FDA Fast Track and Rare Paediatric Disease designation for odiparcil in MPS VI.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (NASDAQ:IVA) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com.

    Contacts

    Inventiva

    Pascaline Clerc

    VP of Global External Affairs

    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
         

    Special Note Regarding Forward-Looking Statements

    This press release contains forward-looking statements, forecasts and estimates with respect to the ATM program, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including the timing and use, if any, of the ATM program, that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, preclinical studies and clinical development programs and timelines, and its financial condition and results of PRESS RELEASE 4 operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Please refer to the Universal Registration Document for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, under number D.21-0124, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021, Amendment No. 1 to our Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 24, 2021, as well as the half-year financial report for the period ended June 30, 2021 and the Form 6-K for the six months ended June 30, 2021 for additional information in relation to such factors, risks and uncertainties. Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements. This document, as well as other regulated information and all of the Company's press releases, are available on its website and on the AMF website (www.amf-france.org) and are available free of charge on request at the Company's registered office at 50, rue de Dijon, 21121 Daix, France.





     

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    • The FDA decision follows the Company's Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed in August 2021

    Daix (France), Long Island City (New York, United States), September 21, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

    This decision follows…

    • The FDA decision follows the Company's Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed in August 2021

    Daix (France), Long Island City (New York, United States), September 21, 2021 – Inventiva (NASDAQ:IVA), a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of non-alcoholic steatohepatitis (NASH), mucopolysaccharidoses (MPS) and other diseases with significant unmet medical need, today announced that the U.S. Food and Drug Administration (FDA) has decided that the Fast Track designation previously granted to lanifibranor in NASH encompasses the treatment of NASH patients with compensated cirrhosis.

    This decision follows a Fast Track designation request for lanifibranor in NASH with compensated cirrhosis filed by Inventiva with the FDA in August 2021. Previously, the FDA had granted both Fast Track and Breakthrough Therapy designations to lanifibranor for the treatment of NASH in September 2019 and October 2020, respectively.

    The FDA's dedicated Fast Track program is designed to facilitate the development and expedite the review and potential approval of drug candidates demonstrating the capacity to treat serious conditions and fill significant unmet medical needs.

    Pierre Broqua, Ph.D., Chief Scientific Officer and cofounder of Inventiva, commented: "We are delighted to have a Fast Track designation for lanifibranor in NASH that extends to the treatment of NASH with compensated cirrhosis, a very severe stage of the disease where patients are in urgent need of treatment. The FDA decision does not only recognize this urgency but also the potential of lanifibranor to address this crucial unmet medical need. This news reinforces our confidence in the unique mechanism of action of our lead drug candidate and confirms our determination to accelerate the development of lanifibranor in its pivotal phase."

    NASH with compensated cirrhosis represents a serious stage of the disease and is becoming the leading cause for liver transplantation, which today represents the only available treatment option for patients who have progressed to end-stage NASH. There is thus an urgent need to develop pharmacological therapies to slow down or halt the progression towards NASH with compensated cirrhosis for NASH patients who are at an increased risk of liver-related morbidity and mortality.

    Given the broad range of activity of lanifibranor as a pan-PPAR agonist on multiple features of NASH, including beneficial effects on metabolism, inflammation, ballooning, fibrosis and vascular manifestations, Inventiva believes that there is a strong rationale to evaluate the efficacy of lanifibranor in NASH patients with compensated cirrhosis.



     

    About Fast Track designation1

    Fast track is a process designed to facilitate the development and expedite the review and potential approval of drug candidates to treat serious, life-threatening conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

    Determining whether a condition is serious is a matter of judgment, but generally is based on whether the drug will have an impact on factors such as survival, day-to-day functioning, or the likelihood that the condition, if left untreated, will progress from a less severe condition to a more serious one.

    Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy. Any drug being developed to treat or prevent a condition with no current therapy is obviously directed at an unmet need. If there are available therapies, a Fast Track drug must show some advantage over available therapy, which is assessed against a pre-defined set of criteria.

    About Inventiva

    Inventiva is a clinical-stage biopharmaceutical company focused on the development of oral small molecule therapies for the treatment of NASH, MPS and other diseases with significant unmet medical need.

    Leveraging its expertise and experience in the domain of compounds targeting nuclear receptors, transcription factors and epigenetic modulation, Inventiva is currently advancing two clinical candidates, as well as a deep pipeline of preclinical programs.

    Lanifibranor, its lead product candidate, is being developed for the treatment of patients with NASH, a common and progressive chronic liver disease for which there are currently no approved therapies. In 2020, Inventiva announced positive topline data from its Phase IIb clinical trial evaluating lanifibranor for the treatment of patients with NASH and obtained both FDA Breakthrough Therapy and Fast Track designation for lanifibranor in the treatment of NASH. Lanifibranor is currently being evaluated in a pivotal Phase III clinical trial.

    Inventiva is also developing odiparcil, a second clinical stage asset, for the treatment of patients with subtypes of MPS, a group of rare genetic disorders. Inventiva announced positive topline data from its Phase IIa clinical trial evaluating odiparcil for the treatment of adult MPS VI patients in 2019 and received both FDA Fast Track and Rare Paediatric Disease designation for odiparcil in MPS VI.

    In parallel, Inventiva is in the process of selecting an oncology development candidate for its Hippo signalling pathway program. Furthermore, the Company has established a strategic collaboration with AbbVie in the area of autoimmune diseases. AbbVie has started the clinical development of ABBV‑157, a drug candidate for the treatment of moderate to severe psoriasis resulting from its collaboration with Inventiva. This collaboration enables Inventiva to receive milestone payments upon the achievement of pre-clinical, clinical, regulatory and commercial milestones, in addition to royalties on any approved products resulting from the collaboration.

    The Company has a scientific team of approximately 70 people with deep expertise in the fields of biology, medicinal and computational chemistry, pharmacokinetics and pharmacology, as well as in clinical development. It also owns an extensive library of approximately 240,000 pharmacologically relevant molecules, approximately 60% of which are proprietary, as well as a wholly‑owned research and development facility.

    Inventiva is a public company listed on compartment C of the regulated market of Euronext Paris (NASDAQ:IVA) and on the Nasdaq Global Market in the United States (NASDAQ:IVA). www.inventivapharma.com.

    Contacts

    Inventiva

    Pascaline Clerc

    VP of Global External Affairs

    media@inventivapharma.com

    +1 240 620 9175
    Brunswick Group

    Yannick Tetzlaff /

    Tristan Roquet Montegon /

    Aude Lepreux

    Media relations

    inventiva@brunswickgroup.com

    +33 1 53 96 83 83
    Westwicke, an ICR Company

    Patricia L. Bank

    Investor relations

    patti.bank@westwicke.com

    +1 415 513 1284
         

    Important Notice

    This press release contains forward-looking statements, forecasts and estimates with respect to Inventiva's clinical trials, clinical development plans and anticipated future activities of Inventiva. Certain of these statements, forecasts and estimates can be recognized by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. Such statements are not historical facts but rather are statements of future expectations and other forward-looking statements that are based on management's beliefs. These statements reflect such views and assumptions prevailing as of the date of the statements and involve known and unknown risks and uncertainties that could cause future results, performance or future events to differ materially from those expressed or implied in such statements. Actual events are difficult to predict and may depend upon factors that are beyond Inventiva's control. There can be no guarantees with respect to the potential benefits Inventiva may realize from Fast Track designation granted to lanifibranor, its ability to accelerate the development of lanifibranor, or that lanifibranor will receive the necessary regulatory approvals. Actual results may turn out to be materially different from the anticipated future results, performance or achievements expressed or implied by such statements, forecasts and estimates, due to a number of factors, including that Inventiva is a clinical-stage company with no approved products and no historical product revenues, Inventiva has incurred significant losses since inception, Inventiva has a limited operating history and has never generated any revenue from product sales, Inventiva will require additional capital to finance its operations, Inventiva's future success is dependent on the successful clinical development, regulatory approval and subsequent commercialization of current and any future product candidates, preclinical studies or earlier clinical trials are not necessarily predictive of future results and the results of Inventiva's clinical trials may not support Inventiva's product candidate claims, Inventiva may encounter substantial delays in its clinical trials or Inventiva may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities, enrollment and retention of patients in clinical trials is an expensive and time-consuming process and could be made more difficult or rendered impossible by multiple factors outside Inventiva's control, Inventiva's product candidates may cause adverse drug reactions or have other properties that could delay or prevent their regulatory approval, or limit their commercial potential, Inventiva faces substantial competition and Inventiva's business, and preclinical studies and clinical development programs and timelines, its financial condition and results of operations could be materially and adversely affected by the current COVID-19 pandemic. Given these risks and uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of this press release. Readers are cautioned not to place undue reliance on any of these forward-looking statements.

    Please refer to the Universal Registration Document for the year ended December 31, 2020 filed with the Autorité des Marchés Financiers on March 15, 2021, the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 15, 2021, Amendment No. 1 to the Annual Report on Form 20-F for the year ended December 31, 2020 filed with the Securities and Exchange Commission on March 24, 2021, as well as the half-year financial report for the six months ended June 30, 2021 for additional information in relation to such factors, risks and uncertainties.

    Except as required by law, Inventiva has no intention and is under no obligation to update or review the forward-looking statements referred to above. Consequently, Inventiva accepts no liability for any consequences arising from the use of any of the above statements.








    1 https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track (12/09/2019).





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