Galmed Pharma: FDA Grants Fast Track Designation To Aramchol - Quick Facts

(RTTNews) - Galmed Pharmaceuticals Ltd. (GLMD) announced Tuesday that the U.S. Food and Drug Administration, or the FDA, approved its request for Fast Track Designation of its product candidate, aramchol, for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH.

According to scientific literature, NASH is a chronic disease that affects approximately12% of the population in United States and in certain European Union nations and its prevalence is expected to increase in parallel with increased rates of obesity and diabetes. There are currently no approved drugs for the treatment of NASH.

As Galmed recently disclosed, Galmed intends to begin, later this year, a Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance in Israel, Europe and certain Latin American countries.

This planned Phase IIb clinical trial is in accordance with the study design recommended by the United Kingdom's Medicines and Healthcare Products Regulatory Agency, deemed acceptable by Germany's Bundesinstitut fur Arzneimittel und Medizinprodukte, or BfArM, deemed satisfactory by France's Agence Nationale de Securite du Medicament et des Produits de Sante, or ANSM, and confirmed as acceptable by the FDA.

BfArM and ANSM also confirmed, in minutes of each of their respective scientific advisory meetings, that if successful, this Phase IIb trial may serve as a basis for Phase III pivotal trials of aramchol.

In addition, the FDA cleared Galmed's Investigational New Drug application for aramchol in July 2014, which, following completion of certain preliminary testing and protocol matters required by the FDA in recent correspondence, will permit Galmed to conduct clinical trials of aramchol in the United States for the treatment of fatty liver disorders.