June 9, 2016 -- Galmed Pharma of Israel has expanded its Phase IIb clinical trial of aramchol, a liver disease treatment, to include a China arm. The announcement is significant because the Galmed trial is most likely one of the first Phase II multinational trials allowed in China. Before last August, when China revamped its regulations governing multinational trials, it was not possible for a company to add a China arm to a Phase II trial. Only Phase III multinational trials were allowed. Aramchol addresses a serious unmet need in China, which no doubt influenced the CFDA’s decision.
