Galmed Medical Research Initiates Phase I Study Of Aramchol, Leading Drug Candidate For Fatty Liver Disease

Main Category: Liver Disease / Hepatitis
Also Included In: Clinical Trials / Drug Trials;  Cholesterol
Article Date: 24 Sep 2008 - 2:00 PDT

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Galmed Medical Research Ltd., a leading biopharmaceutical company that develops innovative proprietary drugs for the treatment of cholesterol and liver diseases, announced today 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."

Non-alcoholic fatty liver disease (NAFLD) is the most common chronic liver disease today in most western countries. In population studies, mostly in adults, prevalence of 20-30% were found and its prevalence is rising rapidly in parallel with the prevalence of obesity. NAFLD may progress to non-alcoholic steatohepatitis (NASH), cirrhosis and its complications in about 25% of cases. It has also recently been found that NAFLD and NASH are strong predisposing factors to atherosclerosis and Cardio Vascular disease.

The market size for a drug for Fatty Liver has been estimated to be around $4.4Billion during the 2nd year of marketing and to grow subsequently. This is for the US only; markets in Europe and the rest of the world could be similar.

Aramchol is a novel discovery product designed to affect liver fat and cholesterol metabolism. The effect is mediated by inhibition of a key enzyme involved in the metabolism of fats in the liver and other tissues, called Stearoyl-CoA desaturase (SCD1). In liver cells (hepatocytes), the drug stimulates the break down of fatty acids, by activating a process called beta oxidation while synthesis of fatty acids is markedly decreased. Both effects contribute thus to the documented decrease in liver triglycerides.

The initiation of the Phase I studies follows the successful completion of toxicological and pharmacological studies. "Of significant interest to the medical community is that Aramchol has been found effective in animal models both before and after establishment of fatty liver disease. It also reduces very markedly plasma cholesterol levels, is devoid of side-effects and has an excellent pharmaceutical profile." said Dr. Itzchak Angel, Galmed's Vice President for Research and Development.

About Galmed Medical Research, Ltd

Galmed Medical Research, Ltd is a leading biopharmaceutical company which develops innovative, proprietary drugs for the treatment of cholesterol and liver diseases. The Company has developed a series of proprietary fatty acid bile-acid conjugates (FABACs) which selectively affect several pathways in lipid metabolism. These compounds have potential in variety of therapies, as demonstrated in several species in vivo and in human cells and tissues in vitro.

Galmed Medical Research, Ltd