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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With still no approved therapy for non-alcoholic steatohepatitis, Intercept, Madrigal, Inventiva and others used the liver meeting to build the cases for their NASH candidates.
German biotech could realize more than $2bn in earnouts under pact with Roivant. Galmed teams with MyBiotics in attempt to optimize clinical response to its Phase III NASH candidate Aramchol.
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.