Galmed To Design Phase III NASH Trial With FDA After Strong Aramchol Data
The Israel-based biopharma company said a Phase IIb trial of its oral treatment of non-alcoholic steatohepatitis hit the necessary endpoints to support a Phase III trial and FDA marketing application.
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Rather than expose patients and others to SARS-CoV-2, Provention opted to pause a Phase III type 1 diabetes trial. Addex and Iveric have since delayed trial initiations and more studies are likely to be impacted as coronavirus concerns mount.
Intercept hopes to be first to market in NASH with an indication to treat fibrosis. It also is enrolling a study to show a benefit in NASH patients with cirrhosis.
Recently filed NDA for obeticholic acid relies on US FDA's specified endpoints for treatment of fibrosis, but European standards are less clear cut, the company acknowledges.