Galmed Medical Research, Ltd
announces today the successful completion of the first part of its Phase-I study in healthy human volunteers of its novel drug, Aramchol, developed for Fatty Liver Disease.
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 1 (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.
This double blind, placebo controlled phase-I trial has been carried out at the Tel-Aviv Sourasky Medical Center (Tel-Aviv, Israel). The study was designed to assess and characterizes the safety and tolerability of Armachol in healthy male subjects at single ascending doses. It was also aimed at assessing the pharmacokinetic profile of the drug following single ascending oral dose administrations.
The Aramchol was given at doses ranging from 30 mg up to 900 mg. The results of this study proved that all doses were well tolerated with no apparent side effects compared to placebo. Also, a dose dependent increase in plasma levels of Aramchol with high absorption of the drug was obtained. This study also confirmed the relatively high elimination half life of the compound suitable for once daily dosing. The next part of the study will be shortly carried out in overweight, mildly hypercholesterolemic, otherwise healthy male subjects receiving multiple doses. It is also aimed at assessing the pharmacokinetics of Aramchol and to characterize the drug effect on lipid profile and functional pharmacodynamics following multiple dose administrations.
The completion of the first part of the Phase I studies follows the successful completion of toxicological and pharmacological studies. "These data are very encouraging and the clinical study confirms the safety and pharmacokinetics of the drug. These results will enable us to continue smoothly to the next phase of the study," said Dr. Itzchak Angel, Galmed's Vice President for Research and Development.
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 rates 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.
About Galmed Medical Research, Ltd
Galmed Medical Research, Ltd is a 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.
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.
Galmed Medical Research, Ltd