Galmed Pharmaceuticals Commences Patient Screening for Aramchol Pharmacokinetic and Food Effect Studies
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 it commenced patient screening for pharmacokinetic, or PK, and food effect studies of aramchol. In written correspondence regarding a requested pre-Investigational New Drug application meeting, the U.S. Food and Drug Administration recommended that Galmed conduct such studies prior to commencing its planned Phase IIb clinical trial of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH, in obese patients with insulin resistance.
Galmed Pharmaceuticals, Ltd. Galmed will conduct the study at the Sourasky Medical Center in Tel Aviv, Israel with Dr. Jacob Atzmon as its principal investigator. The studies are designed for the enrollment of 66 healthy male volunteers who will receive the same two doses of aramchol that Galmed proposes to use in its planned Phase IIb clinical trial. Galmed expects the studies to also provide additional safety data to further support existing safety data from its prior pre-clinical studies and Phase I and Phase IIa clinical trials of aramchol. Galmed anticipates completing the studies by the end of the third quarter of this year.
Following the completion of the PK and food effect studies, Galmed currently plans to initiate its Phase IIb clinical trial of aramchol in Europe and Israel in the fourth quarter of this year.
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