FDA Fast Tracks Galmed's Aramchol For Liver Disorder
Clinical stage biopharmaceutical firm Galmed Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to aramchol for the treatment of Non-Alcoholic Steato-Hepatitis (NASH).
Aramchol is a once daily, potentially disease modifying oral therapy for NASH. The drug belongs to the novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs) and is a conjugate of cholic acid and arachidic acid. Findings from a Phase 2A clinical study show that aramchol significantly reduced liver fat content and enhanced metabolic parameters in relation to fatty liver disease. The drug met all primary endpoints in the trial and demonstrated a favorable safety profile.
NASH is a chronic disease of the liver affecting an estimated 12 percent of the population in the U.S. and certain EU nations. The disease is characterized by inflammation, hepatic steatosis, and hepatocite injury, with or without liver fibrosis. There are currently no approved treatments for NASH.
Allen Baharaff, Galmed's CEO, said, “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.”
The FDA accepted Galmed’s Investigational New Drug (IND) application for aramchol this July. This allows the company to begin its planned randomized, multicenter, double blind, placebo controlled, dose ranging Phase 2B trial to investigate aramchol in 240 patients with NASH who are also afflicted with insulin resistance and obesity. The trial will evaluate the drug against two co-primary endpoints, specifically meaningful reduction of liver fat content and resolution of inflammation as measured by biopsies.
Should the planned Phase 2B trial yield successful results, the company said it will proceed to a pivotal Phase 3 clinical trial for aramchol in 2015.