Galmed Pharmaceuticals to Hold a Symposium on Non-Invasive Diagnostics during the International Liver Congress in Spain

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Apr 07, 2016, 08:00 ET

TEL AVIV, Israel, April 7, 2016 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of a once-daily, oral therapy for the treatment of liver diseases, announced today that it will hold the 2^nd "NASH 2020" forum entitled "NASH: Beyond Liver Biopsy – Current and Next Generation Diagnostic Methods" during the International Liver Congress (ILC), the annual meeting of the European Association for the Study of the Liver (EASL), on April 16^th in Barcelona, Spain.

"NASH 2020" is a discussion and educational forum open by invitation-only to ARREST Study investigators to allow KoLs and researchers an optimal venue to discuss timely and relevant clinical issues related to NASH in the context of Galmed's ongoing ARREST Study.

This year's forum will cover the currently accepted scoring methodologies for non-invasive prediction of NAFLD severity, as well as provide an overview on the latest research of non-invasive biomarkers. New approaches based on blood, metabolomic and microbiome profiling will be reviewed. The forum will also discuss imaging tools, such as MRI and new forms of elastometry methods for non-invasive quantification of hepatic steatosis and fibrosis.

Faculty members include Prof. Vlad Ratzio (Hôpital Pitié Salpêtrière and Université Pierre et Marie Curie, Paris, France), the ARREST Study global Principle Investigator, Prof. Rohit Loomba (University of California at San Diego, California, USA), Prof. José Mato (bioGUNE and CIC biomaGUNE, Basque Country, Spain), amongst others.

Professor Vlad Ratziu, the forum Chairperson, commented, "Providing effective therapies to NASH patients is not just about research and testing of promising compounds in clinical trials. It is also about optimizing performance of non-invasive diagnostic methods that identify patients at risk and follow progression of the disease or treatment response." Prof. Ratziu continued, "With their vision and understanding of the field, Galmed is now a key partner to dedicated investigators worldwide in our collective effort to develop all aspects of NASH management."

Allen Baharaff, President and Chief Executive Officer of Galmed, added "At Galmed, we are acutely aware of the clinical need to develop non-invasive diagnostic tools for NASH, and are devoted to supporting these developments." Mr. Baharaff continued, "We believe that highly valuable information will be generated from the approximately 1000 screened and randomized subjects in the ARREST Study. This data will enable us to collaborate with diagnostic leading companies to develop and validate non-invasive prognostic tools to differentiate between NAFLD and NASH patients, as well as design a complementary diagnostic tool for Aramchol's efficacy." Mr. Baharaff concluded, "Ultimately, Galmed aims to take comprehensive ownership of the patient's treatment path."

About Nonalcoholic Fatty Liver Disease and Nonalcoholic Steatohepatitis:
Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the United States and it affects almost 30% of adults in Western countries. With climbing obesity rates and more sedentary patient populations, the prevalence of NAFLD is increasing worldwide and is becoming the predominant cause of chronic liver disease in parts of the world. NAFLD represents a spectrum of diseases ranging from simple excess liver fat, or steatosis, to nonalcoholic steatohepatitis (NASH). NASH is the progressive form of fatty liver disease that can lead to cardiovascular disease, cirrhosis and liver-related mortality in persons who drink little or no alcohol. NASH represents the more severe end of this spectrum and is characterized by steatosis, ballooning degeneration and lobular inflammation with or without fibrosis. Long-term risks of NASH include cardiovascular disease, cirrhosis, hepatocellular carcinoma and end stage liver disease requiring liver transplantation.

About Galmed Pharmaceuticals Ltd.:
Galmed is a clinical-stage biopharmaceutical company focused on the development of a novel, once-daily, oral therapy for the treatment of liver diseases utilizing its proprietary first-in-class family of synthetic fatty-acid/bile-acid conjugates, or FABACs. Galmed believes that its product candidate, Aramchol^™, has the potential to be a disease modifying treatment for fatty liver disorders, including NASH, which is a chronic disease that Galmed believes constitutes a large unmet medical need. Galmed is currently conducting the ARREST Study, a multicenter, randomized, double blind, placebo-controlled Phase IIb clinical study designed to evaluate the efficacy and safety of Aramchol^™ in subjects with NASH, who are overweight or obese, and who are pre-diabetic or type-II-diabetic. More information about the ARREST Study may be found on ClinicalTrials.gov identifier: NCT02279524.

Forward-Looking Statements:
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. Applicable risks and uncertainties include those identified under the heading "Risk Factors" included in Galmed's most recent Annual Report on Form 20-F filed with the Securities and Exchange Commission, or the SEC, on March 22, 2016, 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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