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Galmed Announces FDA Clearance of IND of Armachol for the Treatment of Fatty Liver Disorders
Date:7/22/2014

to address with aramchol are increasingly relevant public health issues as they are major causes of cardiovascular and liver-related morbidity and mortality, with no approved treatment currently available."

Aramchol, a conjugate of cholic acid and arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates or FABACs. FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters.

As Galmed recently disclosed, Galmed intends to begin, later this year, a multi-center, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb clinical trial of aramchol in 240 NASH patients who also suffer from obesity and insulin resistance.  The trial will have two co-primary end-points: significant reduction of liver fat content measured by NMRS and resolution of inflammation measured by 2 biopsies at the beginning and end of the study. This planned Phase IIb clinical trial for aramchol in NASH patients 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.

To date, in a Phase IIa trial Galmed demonstrated that aramchol may reduce liver fat in a dose dependent manner, as evidenced by a statistically significant reduction of liver fat over a three-month treatment period of once-daily 300 mg doses of aramchol, and may induce positive trends of changes in s
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SOURCE Galmed Pharmaceuticals Ltd.
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