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Aramchol Phase 3 Trial for Non-Alcoholic Steatohepatitis and Liver Fibrosis
Amilo-5MER for Chronic Inflammatory Disorders
Symposium Being Held January 26th at 11am Eastern Time
TEL AVIV, Israel, Jan. 19, 2021 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases, announced today that it will host a Key Opinion Leader (KOL) symposium and pipeline update on Tuesday, January 26, 2021 at 11am Eastern Time. The symposium will primarily focus on Aramchol, currently in Phase 3 for non-alcoholic steatohepatitis (NASH) and liver fibrosis, and Amilo-5MER for chronic inflammatory disorders.
The symposium will feature KOL Arun Sanyal, MD of Virginia Commonwealth University Medical Center, and Shomron Ben-Horin, MD of Tel-Aviv University. The event will provide a detailed overview of Galmed's two pipeline assets, Aramchol in Phase 3 for NASH and fibrosis and Amilo-5MER in development for chronic inflammatory disorders. A Q&A session will follow the formal presentations.
If you are unable to attend the event live, a replay will be available on the Galmed website following the event for a limited time.
Arun Sanyal, MD is Professor of Medicine and Chairman of the Gastroenterology Division of Virginia Commonwealth University (VCU) Medical Center in Richmond, Virginia, USA. Prof. Sanyal also serves as Chairman of the National Institutes of Health (NIH) non-alcoholic steatohepatitis (NASH) Clinical Research Network and the Liver Forum for NASH and fibrosis.
Professor Sanyal's research interests include all aspects of non-alcoholic fatty liver disease and NASH as well as complications of end-stage liver disease. He has served as a member of numerous advisory boards to pharmaceutical companies and the liver center at Yale University. He chaired the hepatobiliary pathophysiology study section of the NIH and was a founding member of the Hepatology Committee of the American Board of Internal Medicine. He has also served as Secretary and President of the American Association for Study of Liver Diseases. Prof. Sanyal is a leading global expert and clinician in chronic liver disease.
Prof. Sanyal is a leader in training future medical researchers and in identifying the mechanisms and clinical outcomes and developing effective management for nonalcoholic fatty liver disease and metabolic syndrome. Professor Sanyal has developed, mediated, and encouraged global liver research as a physician-scientist for over 25 years.
Professor Ben-Horin specializes in inflammatory bowel diseases (IBD) and has received his medical and gastroenterology training in Israel and was a Post-Doc scientist in immunology at Columbia University Presbyterian Hospital in New-York, USA. Prof. Ben-Horin is presently the Chief of the Gastroenterology Department at Sheba Medical Center, Israel, a Full Professor of Medicine at the Tel-Aviv University, and an Adjunct Professor of Medicine at the Sun Yat-Sen University Hospital, Guangzhou, China. He has served as a member of the Scientific Committee of the European Crohn's and Colitis Organization (ECCO) and is presently the Chair of the Israeli IBD Society. Prof. Ben-Horin has published over 200 peer-reviewed scientific papers and is a member of the Editorial Board of the journals Gut, APT and JCC. Prof. Ben-Horin is also the Director of IBD-passport: A web-based global support program for traveling IBD patients.
About Aramchol and Non-alcoholic Steatohepatitis (NASH)
Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, liver targeted SCD1 modulator, developed as an oral therapy for the treatment of nonalcoholic steatohepatitis ("NASH") and fibrosis. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating downregulation of the three key pathologies of NASH: steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by downregulation of steatosis and directly on human collagen producing cells. Aramchol has been granted Fast Track Designation status by the FDA for the treatment of NASH.
NASH is an emerging world crisis impacting an estimated 3% to 5% of the U.S. population and an estimated 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. NASH is the progressive form of non-alcoholic fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality.
About Galmed Pharmaceuticals Ltd.
Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. Our lead compound, Aramchol™, a backbone drug candidate for the treatment of NASH and fibrosis is currently in a Phase 3 registrational study. We are also collaborating with the Hebrew University in the development of Amilo-5MER, a 5 amino acid synthetic peptide and plan to initiate a first in human study by the first quarter of 2021.
This press release may include forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to Galmed's objectives, plans and strategies, as well as statements, other than historical facts, that address activities, events or developments that Galmed intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as "believes," "hopes," "may," "anticipates," "should," "intends," "plans," "will," "expects," "estimates," "projects," "positioned," "strategy" and similar expressions and are based on assumptions and assessments made in light of management's experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statements. Many factors could cause Galmed's actual activities or results to differ materially from the activities and results anticipated in forward-looking statements, including, but not limited to, the following: the timing and cost of Galmed's pivotal Phase 3 ARMOR trial, or the ARMOR Study or any other pre-clinical or clinical trials; completion and receiving favorable results of the ARMOR Study for Aramchol or any other pre-clinical or clinical trial; the impact of the COVID-19 pandemic; regulatory action with respect to Aramchol or any other product candidate by the FDA or the EMA; the commercial launch and future sales of Aramchol or any other future products or product candidates; Galmed's ability to comply with all applicable post-market regulatory requirements for Aramchol or any other product candidate in the countries in which it seeks to market the product; Galmed's ability to achieve favorable pricing for Aramchol or any other product candidate; Galmed's expectations regarding the commercial market for NASH patients or any other indication; third-party payor reimbursement for Aramchol or any other product candidate; Galmed's estimates regarding anticipated capital requirements and Galmed's needs for additional financing; market adoption of Aramchol or any other product candidate by physicians and patients; the timing, cost or other aspects of the commercial launch of Aramchol or any other product candidate; the development and approval of the use of Aramchol or any other product candidate for additional indications or in combination therapy; and Galmed's expectations regarding licensing, acquisitions and strategic operations. More detailed information about the risks and uncertainties affecting Galmed is contained under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the SEC on March 12, 2020, and in other filings that Galmed has made and may make with the SEC in the future. The forward-looking statements contained in this press release are made as of the date of this press release and reflect Galmed's current views with respect to future events, and Galmed does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE Galmed Pharmaceuticals Ltd.