Galmed initiates ARREST Study for potential NASH drug

Galmed Pharmaceuticals announced the beginning of enrollment for its phase 2b clinical trial, also known as the ARREST Study, to test aramchol for the treatment of nonalcoholic steatohepatitis, according to a news release.

The ARREST Study is a randomized, multinational study that will include over 70 clinical centers from 12 countries, including the U.S. Researchers plan to test the efficacy of aramchol for NASH, also looking at efficacy in patients who are obese or experience insulin resistance. The main goals of the study are to see if aramchol leads to a significant reduction of liver fat content measured by magnetic resonance spectroscopy, leads to the complete resolution of NASH and leads to improved NAFLD Activity Score and liver inflammation, according to the release.

“We believe that U.S.-based patient recruitment will shorten the recruitment time for our ARREST Study, as well as improve the study’s breadth and relevance,” Allen Baharaff, chief executive officer of Galmed, said in the release, “Galmed currently expects to release interim results of the ARREST Study in the first half of 2016, later than originally planned, due to our revised geographic strategy of enrollment on the study. Galmed further reaffirmed that it expects to release top-line data by the end of 2016.”

Baharaff further stated: “While the alignment and coordination of the study’s geographic expansion caused a slight delay, we believe we're much better off for adding robust clinical operations in the United States and look forward to the interim results.”

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, a conjugate of cholic acid and arachidic acid, in September 2014.