HEPA Hepion Pharmaceuticals Inc.

1.55
+0.05  (+3%)
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Drug Pipeline

Drug Stage Notes
CRV431 (ASCEND-NASH)
Non-alcoholic steatohepatitis
Phase 2b
Phase 2b
Phase 2a data released July 13, 2021. Primary endpoints met. Further Phase 2a data presented on September 13, 2021. Pro-C3 and ALT reductions point to anti-inflammatory and antifibrotic effects of CRV431, PK-PD models successfully predict early reductions in Pro-C3 and ALT. Phase 2b activities initiated September 13, 2021.

Latest News

    • Pro-C3 and ALT reductions point to anti-inflammatory and antifibrotic effects of CRV431
    • PK-PD models successfully predict early reductions in Pro-C3 and ALT
    • Hepion's proprietary AI-POWR™ and machine learning accurately predict CRV431 responders
    • Anti-fibrotic gene expression signature revealed in bioinformatic analyses
    • Phase 2b activities initiated

    EDISON, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, today announced additional efficacy data from its Phase 2a AMBITION clinical trial.

    AMBITION, a multicenter…

    • Pro-C3 and ALT reductions point to anti-inflammatory and antifibrotic effects of CRV431
    • PK-PD models successfully predict early reductions in Pro-C3 and ALT
    • Hepion's proprietary AI-POWR™ and machine learning accurately predict CRV431 responders
    • Anti-fibrotic gene expression signature revealed in bioinformatic analyses
    • Phase 2b activities initiated

    EDISON, N.J., Sept. 13, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, today announced additional efficacy data from its Phase 2a AMBITION clinical trial.

    AMBITION, a multicenter, randomized, placebo controlled, single-blind Phase 2a trial, enrolled 43 NASH patients. The trial was designed to investigate once daily oral administration of CRV431 at doses of 75 mg (n=12) and 225 mg (n=17) administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety.

    As previously reported, all primary endpoints of the AMBITION NASH trial (safety, tolerability and pharmacokinetics) were met.

    Today, Hepion reports additional data on biomarkers, alanine aminotransferase ("ALT") and N-terminal type III collagen pro-peptide ("Pro-C3"), as well as advanced pharmacologic and bioinformatic analyses that indicate CRV431 efficacy in treating NASH patients.

    Once-daily 225 mg dosing of CRV431 decreased mean Pro-C3 levels by 7.9% (-2.1 ng/ml) and 22.4% (-11.6 ng/ml) at days 28 and 42, respectively, in subjects stratified for baseline Pro-C3 levels greater than 17.5 ng/mL (n=7). Pro-C3 levels greater than 15-20 ng/ml are generally accepted to represent active NASH disease activity and the primary patient population for treatment by many NASH drug candidates. In contrast to the 225 mg CRV431 cohort, placebo treatment similarly stratified by baseline Pro-C3 greater than 17.5 ng/mL (n=9) resulted in a mean increase of 3.5% (0.7 ng/ml) and a mean decrease of 4.7% (-1.6 ng/ml) at days 28 and 42, respectively. The same Pro-C3 baseline stratification for the 75 mg CRV431 dose (n=11) resulted in a mean decrease in Pro-C3 of 9.1% by Day 42, indicating a dose-dependent effect. When stratified for baseline Pro-C3 levels greater than 15.0 ng/mL, 225 mg once daily CRV431 (n=9) reduced mean levels by 4.1% and 14.3% at days 14 and 28 days, respectively, compared to a mean increase of 1.5% and a decrease of 8.8% in the placebo group (n=9) at days 28 and 42, respectively. The reductions in Pro-C3 produced by CRV431 treatment mirror the previously reported dose-dependent declines in ALT.

    Importantly, more detailed analyses of the AMBITION trial data using Hepion's proprietary AI-POWR™ platform provided further evidence of CRV431 efficacy in the treatment of NASH. First, pharmacokinetic-pharmacodynamic ("PK-PD") analyses were able to generate robust models that could predict whether individual patients would show reductions in ALT and Pro-C3 based on CRV431 exposure, baseline ALT, Pro-C3, and other demographic and clinical measurements. Second, analysis of full-genome, ribonucleic acid (RNA) sequencing data ("transcriptomics") from the patients revealed that CRV431 treatment produced changes in gene expression that were consistent with anti-fibrotic effects. Labelled as a collagen-related gene regulatory network, the CRV431-induced changes in gene expression included six key collagen isoforms, and many other structural and enzymatic constituents of the fibrotic matrix. In similarity to the PK-PD models for ALT and Pro-C3, supervised machine learning analyses were able to categorize patients as responders or non-responders based on their transcriptome responses to CRV431 treatment.

    "The decline in Pro-C3 that was observed in the AMBITION trial puts us well within the range of NASH data published by other companies with later-stage NASH drug candidates," said Hepion's Chief Medical Officer, Todd Hobbs MD. "But notably, these declines in Pro-C3 with CRV431 occurred in only 4 weeks, compared to declines with other agents, where the changes occurred over several months."

    "These biomarker findings offer us two important insights. First, CRV431 has sustained effects, as evidenced by the Pro-C3 changes at day 42. The long terminal half-life of CRV431 can explain these findings and, in fact, circulating blood concentrations of CRV431 are present at day 42, even though drug administration stopped on day 28," said Hepion's Senior VP, Clinical Pharmacology & Analytics, Patrick Mayo, PhD.

    "Second, the most recent data generated from our AMBITION trial has allowed us to put our machine learning and proprietary AI-POWR™ to work," continued Dr. Mayo. "We have been able to construct models that may predict a priori who will respond to CRV431. In this context, we believe that we can predict how much of a reduction in ALT and Pro-C3 may be expected in any given subject, even as early as the first administered dose of CRV431. Indeed, we demonstrated that this works very elegantly in predicting ALT and Pro-C3 responses of subjects in the AMBITION trial with a high degree of accuracy. The PK-PD modeling also demonstrated great accuracy in predicting clinical response, as indicated by modeling diagnostics including predicted versus observed plots. Moreover, we have used our transcriptomics to investigate and construct a network of genes that gave us a very consistent picture of antifibrotic effects when CRV431 was tested in the latest clinical program. Interestingly, we also looked at these same genes in our preclinical animal models, our cellular assays, and our studies of human liver slices, and we observed the same findings with the collagen-related gene network."

    "These powerful tools allow us to investigate CRV431 in silico which should allow us to simulate future trials before conducting them in the clinic. The more data we feed into our AI, the more the AI will learn. This, in turn, should enable us to be very precise in this very heterogenous NASH disease. Our AI, therefore, is a very powerful and important tool. The Phase 2a study provided a treasure-trove of information that has allowed us to fine-tune our AI and adjust the design of our planned Phase 2b study," concluded Dr. Mayo.

    Robert Foster, PharmD, PhD, Hepion's CEO, commented, "Dr. Mayo and his team are conducting truly ground-breaking work. Many of us at Hepion have been working on cyclophilin inhibitor drug development for the better part of three decades. But, any kind of drug development is inherently risky, especially when relying solely on traditional tools. We believe we may now be able to mitigate a great deal of development risk with the AI and machine learning tools developed and utilized by our clinical pharmacology group. The fact that our team has been able to identify early changes in important biomarkers and in collagen genes, while developing predictive responder analyses, should help propel us in the NASH drug development space. Ultimately, our goal is to employ our models to optimize trial design, efficiency, cost, and outcomes, while mitigating development risk. In many ways, we believe that what we are doing is unprecedented in NASH drug development. We are confident that the AMBITION trial and our detailed analyses set the stage for success in the upcoming and larger Phase 2b program called, ASCEND-NASH."

    The full AMBITION analysis will be presented by Stephen Harrison, MD, at the upcoming AASLD "The Liver Meeting," in early November 2021.

    Conference Call & Webcast Details

    Hepion is pleased to invite all interested parties to participate in a conference call today at 8:30 a.m. ET, during which both the Phase 2a AMBITION trial data and the design of the planned Phase 2b ASCEND-NASH trial will be discussed. To participate telephonically, please dial (855) 493-3481 (U.S.) or (929) 517-0949 (international), conference ID 3568976, approximately 10 minutes prior to the start time. A live, listen-only webcast of the conference call, which will include accompanying slides, can be accessed by visiting the "Events" page of the "Investors" section at www.hepionpharma.com. An archive of the webcast will be available for approximately 90 days following the conclusion of the conference call.

    About Hepion Pharmaceuticals

    The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.

    Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.

    For further information, please contact:

    Stephen Kilmer

    Hepion Pharmaceuticals Investor Relations

    Direct: (646) 274-3580

    skilmer@hepionpharma.com  



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  1. EDISON, N.J., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, today announced that it expects to release additional data from its Phase 2a ‘AMBITION' NASH clinical trial before the market opens on Monday, September 13, 2021. As previously disclosed, all primary endpoints were achieved in the trial.

    Hepion is pleased to invite all interested parties to participate in a conference call and webcast at 8:30 a.m. ET on September 13, during which the previously disclosed AMBITION topline results, as well as the additional…

    EDISON, N.J., Sept. 10, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on Artificial Intelligence ("AI")-driven therapeutic drug development for the treatment of non-alcoholic steatohepatitis ("NASH") and liver disease, today announced that it expects to release additional data from its Phase 2a ‘AMBITION' NASH clinical trial before the market opens on Monday, September 13, 2021. As previously disclosed, all primary endpoints were achieved in the trial.

    Hepion is pleased to invite all interested parties to participate in a conference call and webcast at 8:30 a.m. ET on September 13, during which the previously disclosed AMBITION topline results, as well as the additional new data, will be discussed.

    To participate telephonically, please dial (855) 493-3481 (U.S.) or (929) 517-0949 (international), conference ID 3568976, approximately 10 minutes prior to the start time. A live, listen-only webcast of the conference call, which will include accompanying slides, can be accessed by visiting the "Events" page of the "Investors" section at www.hepionpharma.com. An archive of the webcast will be available for approximately 90 days following the conclusion of the conference call.

    About Hepion Pharmaceuticals

    The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.

    Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing NASH clinical development program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.

    For further information, please contact:

    Stephen Kilmer

    Hepion Pharmaceuticals Investor Relations

    Direct: (646) 274-3580

    skilmer@hepionpharma.com  



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  2. EDISON, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced the postponement of its adjourned 2021 Annual Meeting of Stockholders (the "Annual Meeting") that was to be held on July 23, 2021, at 9:00 a.m. Eastern Time due to a lack of a quorum. The meeting will be rescheduled for a date yet to be determined by the Board of Directors. The Board of Directors will establish a new record date for the Annual Meeting and, based on this record date, the Company will deliver a notice of the new Annual Meeting date to stockholders…

    EDISON, N.J., July 23, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced the postponement of its adjourned 2021 Annual Meeting of Stockholders (the "Annual Meeting") that was to be held on July 23, 2021, at 9:00 a.m. Eastern Time due to a lack of a quorum. The meeting will be rescheduled for a date yet to be determined by the Board of Directors. The Board of Directors will establish a new record date for the Annual Meeting and, based on this record date, the Company will deliver a notice of the new Annual Meeting date to stockholders entitled to receive notice of the Annual Meeting.

    About Hepion Pharmaceuticals

    The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.

    Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.

    For further information, please contact:

    Stephen Kilmer

    Hepion Pharmaceuticals Investor Relations

    Direct: (646) 274-3580

    skilmer@hepionpharma.com



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    • Safety, Tolerability and Pharmacokinetics ("PK") Primary Endpoints Met
    • Reductions in Liver Transaminases Indicate Dose-Related Improvements in Key NASH Biomarker
    • Concentration-Effect Relationship Demonstrated for ALT Reductions
    • Multiomic Analyses and Machine Learning Paving the Way for Phase 2b, Anticipated to Start Later in 2021

    EDISON, N.J., July 13, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced positive topline results from its Phase 2a ‘AMBITION' NASH clinical trial. All primary endpoints of the trial were met.

    AMBITION…

    • Safety, Tolerability and Pharmacokinetics ("PK") Primary Endpoints Met
    • Reductions in Liver Transaminases Indicate Dose-Related Improvements in Key NASH Biomarker
    • Concentration-Effect Relationship Demonstrated for ALT Reductions
    • Multiomic Analyses and Machine Learning Paving the Way for Phase 2b, Anticipated to Start Later in 2021

    EDISON, N.J., July 13, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced positive topline results from its Phase 2a ‘AMBITION' NASH clinical trial. All primary endpoints of the trial were met.

    AMBITION was a Phase 2a randomized, multi-center, placebo controlled, single-blind trial designed to investigate once daily oral administration of CRV431 at doses of 75 mg and 225 mg administered as soft gelatin capsules to presumed F2 and F3 NASH subjects for 28 days, followed by a 14-day observation period for safety.

    The primary outcome measure of the AMBITION trial was the incidence of safety and tolerability events of CRV431 versus placebo. CRV431 at both study doses was well tolerated, and there were no serious adverse events ("SAEs"), and the few adverse events ("AEs") observed were mostly mild and unrelated to study drug.

    In the AMBITION trial, CRV431 blood concentrations after oral dosing of either 75 mg or 225 mg once daily were in the anticipated effective range for NASH treatment. The drug reached maximum concentrations within two hours after dosing with an effective half-life of approximately 30 hours, which supports once daily dosing.

    It has been reported in recent literature that reductions in serum alanine aminotransferase ("ALT") may be used as a surrogate measure for histologic improvement in NASH.1,2 The AMBITION trial did not include liver biopsies, however early indications of efficacy in the form of ALT reductions were observed with both CRV431 dosing cohorts. The percent ALT change from baseline to Day 28 numerically demonstrated a CRV431 versus placebo dose-response. These declines were statistically significant from placebo (p < 0.05) when CRV431 doses were pooled. Area-under-the ALT-Curve ("AUC") for ALT changes, which has been useful in evaluating the magnitude of effect for clinical laboratory measurements of transaminases in NASH, was also calculated. As set out in the table below, CRV431 demonstrated decreasing ALT AUCs with increasing dose, indicating a positive dose-response. In addition, the 225 mg cohort ALT AUC was statistically different from the placebo group AUC.

    TestPlacebo

    (n=14)
    CRV431 75 mg

    (n=12)
    CRV431 225 mg

    (n=15)
    ALT (% change)-6.1±13.3

    (mean±SD)

    -5.2 (median)
    -18.4±25.8 (mean±SD)*

    -15.9 (median)
    -21.1±21.1 (mean±SD)*

    -20.0 (median)
    Area-Under-the-ALT-Curve (AUC)

    (IU*D/L)
    1465.1 ± 810.91190.5 ± 712.1859.9 ± 387.0**

    *   Pooled 75 mg & 225 mg statistically significant from placebo, p < 0.05, unpaired t-test.

    **Statistically significant from placebo, p < 0.05, ANOVA with Bonferroni Post-Hoc

    "The observed changes in serum ALT at this early timepoint, along with the safety and tolerability data are very encouraging and suggest a potential positive impact of CRV431 on hepatocyte health relative to placebo," commented Stephen Harrison, MD, Principal Investigator of the AMBITION study, Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University. "I am eagerly anticipating additional biomarker data for this cohort and am hopeful to see corroborating evidence of a biochemical effect. Given the chronic nature of this disease, long-term therapy is likely going to be needed and, therefore, a therapy that is well tolerated, oral and once daily would be advantageous."

    "Statistical significance in a dose response on ALT is very encouraging, suggesting a rapid drug effect. A thorough review of literature by our group suggested that a 10% to 15% decline in ALT in four weeks over placebo would indicate a beneficial drug effect," stated Patrick Mayo, Ph.D., Hepion's SVP, Clinical Pharmacology and Analytics. "Our clinical pharmacology group has already developed a population pharmacokinetic-pharmacodynamic, or PK-PD, model which predicts CRV431 blood concentration effect on ALT reductions, which is not usually possible at this early stage in drug development. Additionally, preliminary transcriptomic and lipidomic analyses further support a drug effect when CRV431 blood concentrations exceed 800 ng/mL. This Phase 2a study confirmed CRV431 tolerability and successfully elucidated drug dose range for the upcoming Phase 2b trial."

    "In order to embark on a phase 2b program in NASH, these results were critical to inform us on many key parameters for use of CRV431 in this patient population," said Todd Hobbs, MD, Hepion's Chief Medical Officer. "Despite the challenges of starting clinical research during the COVID pandemic, the team was able to successfully complete this important trial. We look forward to the start of the large Phase 2b ‘ASCEND-NASH' trial later this year, which will evaluate CRV431 in biopsy-proven NASH subjects with advanced fibrosis."

    "CRV431 is a cyclophilin inhibitor that represents a new approach to treating NASH," commented Robert Foster, PharmD, Ph.D., Hepion's CEO. "CRV431 is extensively extracted by the liver after oral dosing and, as such, its potential in treating liver disease is heavily dependent on liver function. We know that liver function declines with NASH, so it was important to design a study to delineate the effects of NASH on the safety, tolerability and PK of CRV431. In addition, this study gave us an opportunity to explore the efficacy potential of CRV431 in NASH subjects. The current findings support this potential, and we will continue to analyze additional incoming data from this trial which should allow us to better understand CRV431. We expect this additional data from the AMBITION trial in the near-term and will report it once we complete our analyses."

    1Hoofnagle, JH, et al. Aliment Pharmacol Ther. 2013; 38:134-143.

    2Loomba, R. Clin Gastroenterol Hepatol. 2014; 12:1731-1732.

    About Hepion Pharmaceuticals

    The Company's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.

    Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.

    For further information, please contact:

    Stephen Kilmer

    Hepion Pharmaceuticals Investor Relations

    Direct: (646) 274-3580

    skilmer@hepionpharma.com  



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  3. EDISON, N.J., June 25, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced that its 2021 Annual Meeting of Stockholders, scheduled for June 25, 2021, has been adjourned due to a lack of quorum. The adjourned meeting will be held at 9:00 a.m. Eastern Time on Friday, July 23, 2021. The record date for determining stockholders eligible to vote on the proposals at the Annual Meeting remains April 29, 2021. A stockholder may use one of the following simple methods to vote:

    EDISON, N.J., June 25, 2021 (GLOBE NEWSWIRE) -- Hepion Pharmaceuticals, Inc. (NASDAQ:HEPA), a clinical stage biopharmaceutical company focused on the development of therapeutic drugs for the treatment of liver disease arising from non-alcoholic steatohepatitis ("NASH"), today announced that its 2021 Annual Meeting of Stockholders, scheduled for June 25, 2021, has been adjourned due to a lack of quorum. The adjourned meeting will be held at 9:00 a.m. Eastern Time on Friday, July 23, 2021. The record date for determining stockholders eligible to vote on the proposals at the Annual Meeting remains April 29, 2021. A stockholder may use one of the following simple methods to vote:

    • Vote by Internet at www.proxyvote.com until 11:59 PM EDT on July 22, 2021 using the control number appearing on the proxy card.

    • Vote by mail by marking, dating and signing the proxy card, and returning it in the postage-paid envelope provided to Philadelphia Stock Transfer, Inc.

    • Vote at the Annual Meeting.

    The Company strongly encourages any eligible stockholder that has not yet voted their shares, or provided voting instructions to their broker or other record holder, to do so promptly. No action is required by any stockholder who has previously delivered a proxy and who does not wish to revoke or change that proxy.

    If you have any questions or need assistance voting your shares, please call Kingsdale Advisors at:

    North American Toll Free Phone:

    1-800-749-9052

    Email: contactus@kingsdaleadvisors.com

    Call Collect Outside North America: 416-867-2272

    About Hepion Pharmaceuticals

    Hepion's lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes. CRV431 is currently in clinical-phase development for the treatment of NASH, with the potential to play an important role in the overall treatment of liver disease - from triggering events through to end-stage disease. CRV431 has been shown to reduce liver fibrosis and hepatocellular carcinoma tumor burden in experimental models of NASH; and has demonstrated antiviral activities towards HBV, HCV, and HDV through several mechanisms, in nonclinical studies.

    Hepion has created a proprietary AI platform, called AI-POWR™, which stands for Artificial Intelligence - Precision Medicine; Omics (including genomics, proteomics, metabolomics, transcriptomics, and lipidomics); World database access; and Response and clinical outcomes. Hepion intends to use AI-POWR™ to help identify which NASH patients will best respond to CRV431, potentially shortening development timelines and increasing the delta between placebo and treatment groups. In addition to using AI-POWR™ to drive its ongoing Phase 2a NASH program, Hepion will use the platform to identify additional potential indications for CRV431 to expand the company's footprint in the cyclophilin inhibition therapeutic space.

    Forward Looking Statements

    Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated," and "intend," among others. These forward-looking statements are based on Hepion Pharmaceuticals' current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; risks associated with delays, increased costs and funding shortages caused by the COVID-19 pandemic; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. Hepion Pharmaceuticals does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Hepion Pharmaceuticals' Form 10-K for the year ended December 31, 2020 and other periodic reports filed with the Securities and Exchange Commission.

    For further information, please contact:

    Stephen Kilmer

    Hepion Pharmaceuticals Investor Relations

    Direct: (646) 274-3580

    skilmer@hepionpharma.com  



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