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UPDATE: Galmed Pharma Reports FDA Approval of Fast Track Designation for Aramchol

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Galmed Pharmaceuticals Ltd.
(Nasdaq: GLMD) ("Galmed"), a clinical-stage biopharmaceutical company focused
on the development and commercialization of a once-daily, oral therapy for the
treatment of liver diseases and cholesterol gallstones, announced today 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. 

FDA Fast Track Designation facilitates the development, and expedites the
review, of drugs which treat a serious or life-threatening condition and fill
an unmet medical need.  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. Further, 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.

Commenting on the FDA's Fast Track Designation of aramchol, Galmed's Chief
Executive Officer, Allen Baharaff, stated: "The Fast Track Designation of
aramchol will allow for continued contact between Galmed and the FDA to
optimally design aramchol's future studies, including clinical trials in the
United States, and may enable Galmed to accelerate its development, FDA
approval and the time to market." 

Posted-In: News FDA Press Releases

 

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