Date: 2014-09-02
Type of information: Completion of the trial
phase: preclinical
Announcement: completion of toxicology studies
Company: Galmed Pharmaceuticals (Israel)
Product: aramchol
Action
mechanism: Aramchol is a conjugate of cholic acid and arachidic acid. This is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters. Aramchol affects liver fat metabolism and has been shown in a phase IIa clinical study to significantly reduce liver fat content as well as improve metabolic parameters associated with fatty liver disease.
Disease: NASH (non-alcoholic steatohepatitis)
Therapeutic area: Hepatic diseases - Liver diseases
Country:
Trial details:
Latest
news: * On September 2, 2014, Galmed Pharmaceuticals, 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 that it successfully completed two six-month chronic toxicology studies of its drug candidate, aramchol. These studies were performed in compliance with the European Medicines Agency\'s ICH M3 (R2) guidelines by WIL Research, a global contract research organization, at its facility in Holland. The studies are required in advance of the commencement of human clinical trials and marketing authorization for pharmaceuticals in Europe and support Galmed\'s planned Phase IIb clinical trial of aramchol for the treatment of Non-Alcoholic Steato-Hepatitis, or NASH, in patients who also suffer from obesity and insulin resistance, which Galmed intends to initiate in the European Union, Israel and Latin America later this year. Galmed is continuing these two toxicology studies for an additional three months to satisfy an initial requirement of the FDA to complete nine-month pre-clinical toxicology studies of aramchol prior to conducting clinical trials in the United States. In a six-month toxicology study in rats, testing a maximum aramchol dose of 1,000 mg/kg per day, WIL Research did not observe any treatment-related mortalities or effects on body weight. In addition, WIL Research did not observe any significant adverse events in the ophthalmologic, hematologic and biochemical testing or in macroscopic and microscopic organ examinations conducted during the study. In a concurrent six-month toxicology study in dogs, testing a maximum aramchol dose of 1,500 mg/kg per day, WIL Research likewise did not observe any treatment-related mortalities or effects on body weight, and did not observe any significant adverse events in the ophthalmologic, hematologic and biochemical testing or in the macroscopic organ examination conducted during the study. However, unlike the study in rats, blood tests revealed a decrease in total blood cholesterol levels, including low-density lipoprotein, or LDL, high-density lipoprotein, or HDL, and phospholipids, and there was a slight increase in the size of the adrenal glands of the dogs, which WIL Research assessed as a physiologic compensatory response to the decrease in blood cholesterol levels. WIL Research did not consider the decrease in blood cholesterol levels or the physiologic response of the adrenal glands as a toxic effect, but rather as a pharmacodynamic effect, which is a biochemical and physiological effect of the drug on the body. No maximum tolerated doses were reached in the studies.
