Galmed Pharmaceuticals Says Ongoing Phase IIB ARREST Trial Expanded To China

Galmed Pharmaceuticals Ltd. GLMD revealed Tuesday it expanded the clinical operations of its ongoing Phase IIb ARREST study into China. According to the company, it commenced a pharmacokinetic ("PK") trial in healthy Chinese subjects domiciled in the United States.

Galmed Pharmaceuticals said the trial investigator in China is Professor George K.K. Lau, who acts as Co-Director of Hepatology at 302 Hospital in Beijing and Director at Humanity and Health Medical Center in Hong Kong. The company added that Professor Lau has a distinguished research career and was recognized as an international leader in clinical trials, primarily in the field of chronic hepatitis B virus (HBV) infection and other liver-related diseases.

The company quoted Professor Lau as having 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." Lau added, "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."

Galmed's president and CEO, Allen Baharaff, reacted, "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."

In parallel, the company 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 said that it expects to enroll a maximum of 64 subjects in this six-month study, consisting of two parts.

The stock traded 2.73 percent higher on Tuesday.