ARREST study for NASH expands to China

Galmed Pharmaceuticals announced its ARREST Study has expanded to China, according to a press release. The phase 2b clinical trial tests aramchol for the treatment of nonalcoholic steatohepatitis.

ARREST is a randomized, multinational study that will include over 70 clinical centers from 12 countries, including the U.S. Researchers will test the efficacy of aramchol (Galmed Pharmaceuticals), a conjugate of cholic acid and arachidic acid, for NASH while also looking at efficacy in patients who are obese or experience insulin resistance.

The trial in China will be led by George K.K. Lau, MD, FAASLD, FRCP, chair professor in clinical hepatology and co-director of The Institute of Translational Hepatology at 302 Hospital in Beijing.

“The significant and unfortunate growth rate in personal lifestyle decisions that give rise to [nonalcoholic fatty liver disease] and NASH in China, and the Far East in general, are worrisome,” Lau said in the release. “Over the last 5 [to] 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. 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 addition to the ARREST study, Galmed initiated a pharmacokinetic study in Chinese patients who are domiciled in the U.S. known as “Pharmacokinetics of Single and Multiple Escalating Doses of Aramchol Administered under Fed Conditions in Healthy Chinese Volunteers.” It is a 6-month study consisting of two parts: 32 individuals will receive a single escalating dose and then 32 additional individuals will receive a multiple escalating dose. Results for the first part of the pharmacokinetics study are expected to be available in August.

“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,” Allen Baharaff, chief executive officer of Galmed, said in the release. “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.”

In a phase 2a clinical trial, aramchol effectively reduced liver fat when taken at 300 mg once daily for 3 months. The FDA granted fast track designation to aramchol in September 2014.

Disclosure: Healio.com/Hepatology was unable to confirm relevant financial disclosures of Lau at the time of publication. Baharaff is employed by Galmed.