Galmed Medical Research Initiates Phase I Study of Aramchol, Leading Drug Candidate for Fatty Liver Disease
Galmed Medical Research Ltd. announced that it has started its Phase-I study in healthy human volunteers of its novel drug, Aramchol, developed for Fatty Liver Disease. This double blind, placebo controlled Phase-I trial was initiated at the Tel-Aviv Sourasky Medical Center (Tel-Aviv, Israel), is designed to assess and characterize the safety and tolerability of Aramchol in healthy male subjects at single doses and subsequently in overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses. It is also aimed at assessing the pharmacokinetics of Aramchol at the administered doses and to characterize the drug effect on lipid profile and functional pharmacodynamics following single and multiple dose administrations.
Aramchol, developed by Prof. Tuvia Gilat, founder and CEO of Galmed Medical Research, is a member of the Fatty Acid Bile Acid Conjugate (FABAC) family and has been demonstrated in several animal species to reduce liver lipids, particularly triglycerides, in pre-established Fatty Liver Disease.
“There have been numerous attempts using both new drug development and known drugs to treat Fatty liver Diseases, but to date no established treatment exists for this disease" said Prof. Gilat. "Following the encouraging efficacy results in our numerous animal modes, we are looking forward to advance the drug into patient population rapidly."
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