Galmed Pharma Reports Expansion of Ongoing Phase IIb ARREST Study to China

Galmed Pharmaceuticals Ltd.

("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 has expanded the clinical operations of its ongoing Phase IIb ARREST study into China and has also commenced a pharmacokinetic ("PK") study in healthy Chinese subjects domiciled in the United States. The trial investigator in China is Professor George K.K. Lau, who serves as Co-Director of Hepatology at 302 Hospital in Beijing and Director at Humanity and Health Medical Center in Hong Kong. Professor Lau has a distinguished research career and is recognized as an international leader in clinical trials, primarily in the field of chronic hepatitis B virus (HBV) infection and other liver-related diseases. Professor Lau has more than 500 publications in scientific journals, such as the New England Journal of Medicine, Lancet, Gastroenterology, Journal of Hepatology, Hepatology and Blood. Professor Lau commented, "The significant, and unfortunate, growth rate in personal lifestyle decisions that give rise to NAFLD and NASH in China, and the Far East in general, are worrisome. Over the last 5-10 years, the scientific and medical community in China and beyond have awoken to this reality and concluded that this disease represents a significant unmet need." Professor Lau concluded, "I'm enthusiastic to investigate the effect of Aramchol™ on NASH patients and its seeming ability to hit important molecular targets, and affect change, in this complex disease." In parallel, Galmed has also initiated a pharmacokinetic ("PK") study in Chinese subjects who are domiciled in the United States, entitled "Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered under Fed Conditions in Healthy Chinese Volunteers." The Company expects to enroll up to 64 subjects in this six-month study, consisting of two parts. In part A, 32 subjects shall receive a single escalating dose; Part B shall enroll 32 subjects which shall receive a multiple escalating dose. Dr. Evelyn Darius will serve as the Study Investigator. If the PK profile from Part A is similar to the existing PK data in non-Chinese subjects, then the study may be stopped prior to enrolling Part B. The results of Part A of the PK study are expected to be available in August 2016. Allen Baharaff, Galmed's President and Chief Executive Officer stated, "With an increasing obesity and diabetes epidemic in the Chinese population, in proportions similar to the Western world, we believe China is likely to experience an increasing outbreak of NASH and NAFLD patients." New epidemiology data recently presented at the 3rd Chinternational Hepatology Symposium (CIHS) in Beijing indicate that NAFLD could replace viral hepatitis as the leading cause of chronic liver disease in China. Mr. Baharaff concluded, "It's important that we are undertaking this expansion now and assuming a leadership position in this strategic market. This trial will contribute to the extension of the clinical development of Aramchol internationally and, in particular, in China, where CFDA regulations demands full clinical development before approval."