GOSS Gossamer Bio Inc.

8.93
-0.6  -6%
Previous Close 9.53
Open 9.3
52 Week Low 7.52
52 Week High 27.1497
Market Cap $642,500,825
Shares 71,988,888
Float 55,782,747
Enterprise Value $266,143,102
Volume 656,761
Av. Daily Volume 802,715
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Upcoming Catalysts

Drug Stage Catalyst Date
GB002
Pulmonary arterial hypertension (PAH)
Phase 1b
Phase 1b
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GB1275
Solid tumors
Phase 1/2
Phase 1/2
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Drug Pipeline

Drug Stage Notes
GB001
Nasal polyps / chronic rhinosinusitis
Phase 2
Phase 2
Phase 2 trial did not meet primary endpoint - October 13, 2020.
GB001
Eosinophilic asthma
Phase 2b
Phase 2b
Phase 2b trial did not meet primary endpoint - October 13, 2020.
AKB-4924 (GB004) - SHIFT-UC
Ulcerative Colitis
Phase 2
Phase 2
Phase 2 trial to commence 2H 2020.

Latest News

  1. The trial in moderate-to-severe patients is Aerpio's second clinical trial in COVID-19 patients and is funded in part by the U.S. military

    The military-sponsored trial is complementary to the previously announced I-SPY COVID-19 trial where razuprotafib is being assessed in critically ill COVID-19 patients; those already on high flow oxygen or ventilator

    CINCINNATI, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome…

    The trial in moderate-to-severe patients is Aerpio's second clinical trial in COVID-19 patients and is funded in part by the U.S. military

    The military-sponsored trial is complementary to the previously announced I-SPY COVID-19 trial where razuprotafib is being assessed in critically ill COVID-19 patients; those already on high flow oxygen or ventilator

    CINCINNATI, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc. ("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections, today reported dosing of its first patient in the Phase 2 trial targeting the prevention and treatment of ARDS in patients with moderate-to severe COVID-19. Further details about the study can be found here.

    "We commend our clinical team and the trial investigators who have established a close collaboration in this important program," said Joseph Gardner, President and Founder of Aerpio. "Razuprotafib may also benefit COVID-19 patients who have not yet progressed to ARDS, and we hope that it may fill the need for effective therapeutics for this devastating disease while vaccine development advances. Additionally, therapeutics that can prevent or treat ARDS in COVID-19 may prove useful in other diseases where ARDS is the primary cause of morbidity and mortality."

    About Aerpio Pharmaceuticals

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    About Razuprotafib (formerly known as AKB-9778)

    Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy. In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19.

    Forward Looking Statements

    This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the Company's product candidates, including razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company's plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company's collaboration with Gossamer Bio for GB004, including the continued development of GB004 and the milestone and royalty payments related to the collaboration. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the continued development of GB004 and maintaining and deriving the intended benefits of the Company's collaboration with Gossamer Bio; ability to continue to develop razuprotafib or other product candidates, including in indications related to COVID-19; the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, the design of planned or future clinical trials, commencing clinical trials and enrollment of patients in clinical trials; obtaining any necessary regulatory clearances in order to commence and conduct planned or future clinical trials; the impact of the ongoing COVID-19 pandemic on the Company's business operations, including research and development efforts and the ability of the Company to commence, conduct and complete its planned clinical activities; and competition in the industry in which the Company operates and overall market conditions; and the additional factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q and our other subsequent filings with the SEC.

    These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.

    Contacts

    Investors & Media:

    Aerpio Pharmaceuticals, Inc.

    Joseph Gardner

    President & Founder

    Gina Marek

    VP Finance

    Or



    Investors:

    Irina Koffler

    LifeSci Advisors

    Source: Aerpio Pharmaceuticals, Inc.

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  2. - Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups -

    - Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group -

    - TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints -

    - Gossamer to hold webcast to discuss trial results at 8:00 am EDT -

    Gossamer Bio, Inc. (NASDAQ:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology…

    - Primary endpoint of asthma worsening not met in LEDA Study, however consistent numeric reductions ranging from 32-35% observed across all three GB001 groups -

    - Statistically significant improvements in key secondary endpoint of time to first asthma worsening of 28% and 30% observed for 20 mg and 60 mg doses of GB001, respectively; 23% improvement observed in 40 mg group -

    - TITAN Study in chronic rhinosinusitis did not meet primary or secondary endpoints -

    - Gossamer to hold webcast to discuss trial results at 8:00 am EDT -

    Gossamer Bio, Inc. (NASDAQ:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced topline results from its Phase 2b LEDA trial in patients with moderate-to-severe eosinophilic asthma and its Phase 2 TITAN trial in patients with chronic rhinosinusitis.

    "While we did not achieve statistical significance on the primary endpoint in the LEDA Study, we are encouraged by the consistent results observed for all three doses of once-daily, oral GB001 therapy across the primary and secondary endpoints," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer. "We believe these data provide important information for designing a well-powered Phase 3 program for GB001 in severe asthma. We plan to engage in global regulatory discussions in order to inform our thinking around potential partnerships or strategic alternatives for this program."

    "The results of the robust LEDA Study are meaningful and help us to further understand the DP2 pathway in asthma," said Bruce Levy, M.D., Chief, Division of Pulmonary and Critical Care Medicine at Brigham and Women's Hospital and Professor of Medicine at Harvard Medical School. "I believe GB001 as an oral treatment has the potential to serve the high unmet need of patients with uncontrolled severe asthma."

    LEDA Phase 2b Trial Design

    The LEDA trial enrolled 480 patients with uncontrolled, moderate-to-severe eosinophilic asthma and assessed the effect of oral GB001 add-on therapy to standard of care over 24 weeks, comparing three dose groups of once-daily, oral GB001 (20 mg, n=120; 40 mg, n=118; and 60 mg, n=122) to placebo (n=120).

    The primary endpoint, asthma worsening, included five components and was chosen for its sensitivity in detecting deterioration in clinical outcome measures known to be correlated with exacerbations. A patient was considered to have experienced asthma worsening if they met any of the five components by Week 24. This endpoint has previously been used in the context of steroid withdrawal studies, including a prior Phase 2 trial of GB001.

    LEDA Primary and Secondary Endpoint Results

    The primary endpoint of the trial was not met, though consistent and meaningful numeric reductions in the odds of asthma worsening as compared to placebo were observed across all GB001 groups: 33% (p=0.1425), 32% (p=0.1482), and 35% (p=0.1086), for the GB001 20 mg, 40 mg, and 60 mg groups, respectively. In addition, statistically significant improvements in the key secondary endpoint of time to first asthma worsening as compared to placebo were observed for GB001 20 mg and 60 mg (28% and 30% risk reduction, p=0.0466 and p=0.0304, respectively), with GB001 40 mg also demonstrating a numeric improvement (23%, p=0.1222).

    Consistent reductions for each GB001 group as compared to placebo were seen across all individual components of the asthma worsening endpoint. In a post-hoc analysis, the odds of experiencing severe asthma worsening (i.e. meeting three or more worsening components), were significantly reduced in all three GB001 groups as compared to placebo (72%, 88%, and 81% reductions, p=0.0044, 0.0003, and 0.0008, for GB001 20 mg, 40 mg, and 60 mg, respectively).

    In addition to the primary endpoint of asthma worsening, the expected Phase 3 registrational endpoint of annualized severe exacerbation rate, or AER, was evaluated as a secondary endpoint. While AER is typically formally evaluated in large Phase 3 studies with a one-year duration, reductions as compared to placebo were seen for each GB001 group (GB001 20 mg: 20%; 40 mg: 25%; 60 mg: 11%), although the reductions were not statistically significant.

    Numeric improvements in lung function, as measured by morning peak expiratory flow and pre-bronchodilator FEV1, and asthma control, as measured by the Asthma Control Questionnaire were also observed for all three GB001 groups compared to placebo.

    The trial also provided the opportunity to investigate subgroups based on clinical characteristics and biomarkers. In a post-hoc analysis, a subgroup of patients was preliminarily identified with enhanced treatment response that could allow for the enrollment of an enriched patient population in future studies. We will continue to analyze the clinical data collected in the study, including further characterization of this subgroup.

    Overall, the Phase 2b LEDA Study informed on the Phase 3 registrational endpoint, the optimal patient population and dose selection for future studies. We look forward to discussing our findings with global regulatory authorities and continuing our discussions with potential strategic partners.

    LEDA Safety and Tolerability Results

    The incidence of adverse events was generally comparable across treatment groups: 65.8% placebo, 65.8% GB001 20 mg, 69.5% GB001 40 mg, and 68.0% GB001 60 mg.

    Adverse events of interest (liver chemistry elevations leading to study drug discontinuation) occurred more frequently in GB001 60 mg (4.1%, n=5) than placebo (0.8%, n=1), GB001 20 mg (0.8%, n=1), or GB001 40 mg (1.7%, n=2). One adverse event of interest was a serious adverse event of liver chemistry elevations meeting Hy's Law criteria in the GB001 60 mg group. The patient was asymptomatic during the event, which was reversible and resolved without sequelae.

    Full results from LEDA will be submitted for future presentation at an upcoming scientific meeting.

    TITAN Phase 2a Trial in Chronic Rhinosinusitis with and without Nasal Polyps

    The proof-of-concept TITAN trial enrolled 97 patients with chronic rhinosinusitis with and without nasal polyps and assessed treatment with GB001 40 mg vs. placebo over 16 weeks. Neither the primary nor the secondary endpoints of the trial were met. The safety and tolerability of GB001 40 mg was generally consistent with that observed in the LEDA Study. We do not plan to continue further development of GB001 in chronic rhinosinusitis.

    Conference Call and Webcast

    Gossamer's management team will host a conference call and live audio webcast at 8:00am EDT today, Tuesday, October 13, to discuss its GB001 Phase 2 clinical trial results.

    The live audio webcast may be accessed through the Events/Presentations page in the Investors section of the Company's website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

    Conference ID: 1333166

    Domestic Dial-in Number: (833) 640-7726

    International Dial-in Number: (602) 585-9912

    Live Webcast: https://edge.media-server.com/mmc/p/6yqpwnxf

    A replay of the audio webcast will be available for 30 days on the Investors section of the Company's website, www.gossamerbio.com.

    About GB001

    GB001 is a potent and highly selective oral antagonist of the DP2 pathway, a potentially important modulator of the inflammatory cascade in asthma. GB001 is an investigational, once-daily tablet being developed as an add-on maintenance treatment for moderate-to-severe uncontrolled asthma.

    About the GB001 Phase 2b LEDA Study

    LEDA (GB001-2001, NCT03683576) was a 24-week, randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2b trial in patients with moderate-to-severe eosinophilic asthma. The patient population included 480 adult patients, randomized equally to placebo, GB001 20 mg, GB001 40 mg, and GB001 60 mg, who were receiving Global Initiative for Asthma (GINA) Step 4 or 5 standard of care treatment with inhaled medium or high dose corticosteroids and at least one additional asthma controller medication. The objective of the trial was to evaluate the efficacy and safety of GB001 relative to placebo when added to standard of care treatment.

    The primary endpoint was the proportion of patients who experienced asthma worsening by Week 24. Asthma worsening was a composite outcome defined as the occurrence of any one of the following at any time by Week 24: deterioration of morning peak expiratory flow, pre-bronchodilator forced expiratory volume in 1 second (FEV1), or asthma control as measured by the Asthma Control Questionnaire 5, relative to baseline; an increase in rescue medication use relative to baseline; or the occurrence of a severe asthma exacerbation, defined as deterioration of asthma that led to the use of systemic corticosteroids for at least 3 days, hospitalization, or an Emergency Department visit.

    Secondary endpoints included time to first asthma worsening and the annualized rate of severe asthma exacerbations.

    The safety of GB001 was assessed by adverse events, clinical laboratory tests, electrocardiograms, and vital signs.

    About the GB001 Phase 2 TITAN Study

    TITAN (GB001-2101, NCT03956862) was a 16-week, randomized, double-blind, placebo-controlled, dose-ranging, multi-center Phase 2 trial in patients with chronic rhinosinusitis with and without nasal polyps. The patient population included 97 adult patients, randomized equally to placebo and GB001 40 mg, stratified by nasal polyp status. The objective of the trial was to evaluate the efficacy and safety of GB001 40 mg relative to placebo when added to standard of care treatment of intranasal corticosteroids.

    The primary endpoint was the change from baseline to Week 16 in SNOT-22, a patient-reported, quality of life instrument that assesses the impact of chronic rhinosinusitis. A key secondary endpoint in subjects with nasal polyps was the change from baseline to Week 16 in nasal polyp score.

    The safety of GB001 was assessed by adverse events, clinical laboratory tests, electrocardiograms, and vital signs.

    About Gossamer Bio

    Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

    Forward-Looking Statements

    Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the potential for the LEDA Study results to allow for the design of a well-powered Phase 3 program for GB001 and our plans to discuss such results with global regulatory authorities to inform potential partnerships or strategic alternatives; potential plans to advance GB0O1; and the potential of GB001 to serve asthma patients. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of our plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer's business, including, without limitation: Gossamer may not proceed into Phase 3 clinical trials for GB001, including because the LEDA Study results may not support continued clinical development of GB001; topline results Gossamer reports is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial, and the FDA and other regulatory authorities may not agree with Gossamer's interpretation of such results; disruption to our operations from the recent global outbreak of the COVID-19 pandemic, including clinical trial and regulatory meeting delays; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; potential delays in the commencement, enrollment and completion of any future clinical trials of GB001 and the success of any such trials; Gossamer may not be successful in establishing strategic partnerships or collaborations and may not realize the benefits of such arrangements; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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  3. - Newly disclosed data build on topline results and continue to support GB004's differentiated approach of targeting epithelial barrier restoration in patients with ulcerative colitis -

    - GB004 demonstrated superior barrier protection compared to tofacitinib in pre-clinical human monolayer assay -

    - SHIFT-UC Phase 2 study active and screening patients for enrollment -

    Gossamer Bio, Inc. (NASDAQ:GOSS), today announced multiple updates for its GB004 program. GB004 is an oral, gut-targeted HIF-1α stabilizer, designed to promote mucosal healing and resolve local inflammation through a non-immunosuppressive mechanism of action in patients with inflammatory bowel disease.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005210/en/

    - Newly disclosed data build on topline results and continue to support GB004's differentiated approach of targeting epithelial barrier restoration in patients with ulcerative colitis -

    - GB004 demonstrated superior barrier protection compared to tofacitinib in pre-clinical human monolayer assay -

    - SHIFT-UC Phase 2 study active and screening patients for enrollment -

    Gossamer Bio, Inc. (NASDAQ:GOSS), today announced multiple updates for its GB004 program. GB004 is an oral, gut-targeted HIF-1α stabilizer, designed to promote mucosal healing and resolve local inflammation through a non-immunosuppressive mechanism of action in patients with inflammatory bowel disease.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201012005210/en/

    Median Reduction from Baseline in Fecal Calprotectin (Graphic: Business Wire)

    Median Reduction from Baseline in Fecal Calprotectin (Graphic: Business Wire)

    Data Presented at UEGW Virtual 2020

    William Sandborn, M.D., Chief of the Division of Gastroenterology of University of California San Diego, presented data at the UEGW Virtual Week 2020 from the successful Phase 1b translational medicine study of GB004 in mild-to-moderate ulcerative colitis, or UC.

    The Phase 1b study evaluated safety, tolerability, and pharmacokinetics over 4 weeks of treatment in patients with active UC despite treatment with 5-aminosalicylate (5-ASA) therapy. In addition to trends disclosed earlier this year, the presentation included newly disclosed data on the reduction of an important inflammatory biomarker in IBD, fecal calprotectin, and the resolution of rectal bleeding, which is considered to be an objective measure of disease activity.

    Key Exploratory Outcomes

    Outcome / Biomarker (4 weeks)

    Placebo

    GB004

    Mucosal Healing

    0% (0/11)

    17% (4/23)

    Histologic Remission

    18% (2/11)

    43% (10/23)

    Resolution of Rectal Bleeding

    36% (4/11)

    57% (12/21)

    Reduction from Baseline in Fecal Calprotectin

    7% (n=11)

    38% (n=21)

    GB004's differentiated mechanism of action was also highlighted in a second poster summarizing data from two pre-clinical studies. In a human monolayer assay, GB004 demonstrated superior protection of barrier integrity compared to tofacitinib, a pan-JAK inhibitor approved for the treatment of moderate-to-severe UC. In a separate mouse organoid study, GB004 induced HIF-1α-dependent genes, including barrier function genes such as Claudin 1, which were elevated in patients in the Phase 1b trial, further validating GB004's mechanism of action.

    Both posters presented at UEGW Virtual Week 2020 and a replay of Dr. Sandborn's presentation can now be viewed in the "Posters & Publications" of Gossamer's website at https://www.gossamerbio.com/pipeline/posters-and-publications/.

    GB004 SHIFT-UC Phase 2 Study in Patients with Active Mild-to-Moderate UC

    Gossamer has begun screening patients in a global Phase 2 study of GB004 in patients with active ulcerative colitis despite treatment with 5-ASA (NCT04556383). Up to 195 subjects are expected to be enrolled, randomized evenly across two dose arms of GB004 and placebo.

    The primary endpoint of the study is clinical remission at week 12. Patients will continue blinded treatment through week 36, after which they will have the option to roll onto an open-label extension. Additional endpoints such as mucosal healing, histologic remission, clinical response, and disease clearance also will be assessed.

    About Gossamer Bio

    Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

    Forward-Looking Statements

    Gossamer cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding plans to advance our product candidates and the potential clinical benefits of our product candidates. The inclusion of forward-looking statements should not be regarded as a representation by Gossamer that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Gossamer's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; disruption to our operations from the recent global outbreak of the COVID-19 pandemic, including clinical trial delays; the Company's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; the results of preclinical studies and early clinical trials are not necessarily predictive of future results; the success of Gossamer's clinical trials and preclinical studies for its product candidates; interim results do not necessarily predict final results and one or more of the outcomes may materially change as the trial continues and more patient data become available and following more comprehensive audit and verification procedures; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of our product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Gossamer's ability to obtain and maintain intellectual property protection for its product candidates; Gossamer's ability to comply with its obligations in collaboration agreements with third parties or the agreements under which it licenses intellectual property rights from third parties; Gossamer may use its capital resources sooner than it expects; and other risks described in the Company's prior press releases and the Company's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in the Company's annual report on Form 10-K and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Gossamer undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

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  4. Gossamer Bio, Inc. (NASDAQ:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced that it will present data relevant to GB004 at United European Gastroenterology Virtual Week 2020, which takes place from October 11th through 13th.Thisincludes an oral presentation from William Sandborn, M.D., Chief of the Division of Gastroenterology of University of California San Diego, detailing clinical data from the completed GB004 Phase 1b trial in patients with active mild-to-moderate ulcerative colitis.

    Details for presentations related to GB004, a HIF-1α stabilizer in clinical development for the treatment

    Gossamer Bio, Inc. (NASDAQ:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, today announced that it will present data relevant to GB004 at United European Gastroenterology Virtual Week 2020, which takes place from October 11th through 13th. This includes an oral presentation from William Sandborn, M.D., Chief of the Division of Gastroenterology of University of California San Diego, detailing clinical data from the completed GB004 Phase 1b trial in patients with active mild-to-moderate ulcerative colitis.

    Details for presentations related to GB004, a HIF-1α stabilizer in clinical development for the treatment of inflammatory bowel disease, are as follows:

    Session Type: Moderated Poster Session

    Session Title: IBD Clinical II

    Poster Code: P0589

    Poster Title: Safety, Pharmacokinetic, Biomarker, Histologic, and Rectal Bleeding Activity Following Treatment with the Gut-Targeted, PHD-Inhibitor and HIF-1α Stabilizer GB004 in a Phase 1b Trial in Mild-to-Moderate Ulcerative Colitis

    Presenting Author: William Sandborn, M.D.

    Date: Sunday, October 11th

    Time: 3:40pm CEST / 9:40am EDT / 6:40am PDT

    Session Type: E-Poster Session

    Session Title: Poster Exhibition

    Poster Code: P0562

    Poster Title: GB004 exhibits protective effects directly on epithelial cells using ex vivo organoid and monolayer cultures

    Presenting Author: Kristen Taylor Meadows, Ph.D.

    About Gossamer Bio

    Gossamer Bio is a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology. Its goal is to be an industry leader in each of these therapeutic areas and to enhance and extend the lives of patients suffering from such diseases.

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  5. CINCINNATI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc.("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections, today announced that it has completed patient enrollment in its double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure (IOP) associated with open angle glaucoma (OAG) or ocular hypertension (OHT).

    The study is designed to evaluate the safety and efficacy of a topical ocular…

    CINCINNATI, Sept. 15, 2020 (GLOBE NEWSWIRE) -- Aerpio Pharmaceuticals, Inc.("Aerpio") (NASDAQ:ARPO), a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections, today announced that it has completed patient enrollment in its double-blind, placebo-controlled Phase 2 trial in patients with elevated intraocular pressure (IOP) associated with open angle glaucoma (OAG) or ocular hypertension (OHT).

    The study is designed to evaluate the safety and efficacy of a topical ocular formulation of razuprotafib in approximately 195 patients followed over a 28-day period, and patients must undergo a 28-day washout prior to randomization.  Patients enrolled in the trial are administered a baseline of latanoprost ophthalmic solution 0.005%, and then randomized in a 1:1:1 fashion to receive adjunctive therapy consisting of placebo, 40 mg/ml razuprotafib once-daily, or 40 mg/ml razuprotafib twice-daily. The primary endpoint of the study is mean diurnal IOP at 28 days in the razuprotafib treated groups compared to the latanoprost monotherapy group.

    "We remain on track to report top line results from this trial in the fourth quarter," said Kevin Peters, M.D., Chief Scientific Officer and Chief Medical Officer of Aerpio. "We believe that razuprotafib will represent an attractive adjunctive therapy for glaucoma patients based on its novel mechanism of action and favorable tolerability profile, and we have worldwide rights to the program." 

    About Aerpio Pharmaceuticals

    Aerpio Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing compounds that activate Tie2 to treat ocular diseases and diabetic complications, as well as other indications in which the Company believes that activation of Tie2 may have therapeutic potential, including acute respiratory distress syndrome ("ARDS") associated with COVID-19 infections. Recently published mouse and human genetic data implicate the Angpt/Tie2 pathway in maintenance of Schlemm's canal, a critical component of the conventional outflow tract. The Company's lead compound, razuprotafib (formerly AKB-9778), a first-in-class small molecule inhibitor of vascular endothelial protein tyrosine phosphatase ("VE-PTP"), is being developed as a potential treatment for open angle glaucoma, and the Company intends to investigate the therapeutic potential of razuprotafib in other indications.. The Company is also evaluating development options for ARP-1536, a humanized monoclonal antibody, for its therapeutic potential in the treatment of diabetic vascular complications including nephropathy and diabetic macular edema ("DME"). The Company's third asset is a bispecific antibody that binds both VEGF and VE-PTP which is designed to inhibit VEGF activation and activate Tie2. This bispecific antibody has the potential to be an improved treatment for wet age-related macular degeneration and DME via intravitreal injection. Finally, the Company has exclusively out-licensed AKB-4924 (now called GB004), a first-in-class small molecule inhibitor of hypoxia-inducible factor-1 (HIF). GB004 is being developed by AKB-4924's exclusive licensor, Gossamer Bio, Inc. (NASDAQ:GOSS). For more information, please visit www.aerpio.com.

    About Razuprotafib (formerly known as AKB-9778)

    Razuprotafib binds to and inhibits vascular endothelial protein tyrosine phosphatase (VE-PTP), an important negative regulator of Tie2. Decreased Tie2 activity contributes to vascular instability in many diseases including diabetes and more recently has been shown to contribute to the development of increased IOP and glaucoma. Razuprotafib activates the Tie2 receptor irrespective of extracellular levels of its binding ligands, angiopoietin-1 (agonist) or angiopoietin-2 (antagonist) and may be the most efficient pharmacologic approach to maintain normal Tie2 activation. Aerpio is studying a topical ocular formulation of razuprotafib in open angle glaucoma and exploring the utility of subcutaneous razuprotafib for diabetic complications, including diabetic nephropathy.  In addition, a subcutaneous formulation of razuprotafib is being explored for its therapeutic potential in treating or preventing ARDS associated with COVID-19. 

    Forward Looking Statements

    This press release contains forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, the Company's product candidates, including razuprotafib, ARP-1536 and the bispecific antibody asset, the clinical development plan therefor and the therapeutic potential thereof, the Company's plans and expectations with respect to razuprotafib and the development therefor and therapeutic potential thereof in addressing COVID-19 and the intended benefits from the Company's collaboration with Gossamer Bio for GB004, including the continued development of GB004 and the milestone and royalty payments related to the collaboration. Actual results could differ from those projected in any forward-looking statements due to several risk factors. Such factors include, among others, the continued development of GB004 and maintaining and deriving the intended benefits of the Company's collaboration with Gossamer Bio; ability to continue to develop razuprotafib or other product candidates, including in indications related to COVID-19; the inherent uncertainties associated with the drug development process, including uncertainties in regulatory interactions, the design of planned or future clinical trials, commencing clinical trials and enrollment of patients in clinical trials; obtaining any necessary regulatory clearances in order to commence and conduct planned or future clinical trials; the impact of the ongoing COVID-19 pandemic on the Company's business operations, including research and development efforts and the ability of the Company to commence, conduct and complete its planned clinical activities; and competition in the industry in which the Company operates and overall market conditions; and the additional factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2019, as updated by our subsequent Quarterly Reports on Form 10-Q and our other subsequent filings with the SEC.

    These forward-looking statements are made as of the date of this press release, and the Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the Company files with the SEC available at www.sec.gov.

    Contacts

    Investors & Media:

    Aerpio Pharmaceuticals, Inc.

    Joseph Gardner

    President & Founder

    Gina Marek

    VP Finance

    Or

    Investors:

    Irina Koffler

    LifeSci Advisors

    Source: Aerpio Pharmaceuticals, Inc.

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