Date: 2016-03-01
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Galmed Pharmaceuticals (Israel)
Product: aramchol
Action mechanism: bile-acid conjugate. 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: HIV-associated lipodystrophy and nonalcoholic fatty liver disease (NAFLD)
Therapeutic area: Hepatic diseases - Liver diseases
Country: USA
Trial details: The ARRIVE (ARamchol™ for the Reversal of HIV-AssociatEd Lipodystrophy and NAFLD) Study is a randomized, double-blinded, allocation-concealed, placebo-controlled, proof-of-concept Phase IIa clinical trial is an investigator-initiated study. It is conducted at the University of California San Diego by Professor Rohit Loomba. The study will evaluate up to 50 patients with HIV-Associated Lipodystrophy and NAFLD, with either Aramchol™ at 600 mg or placebo for 12 weeks. Pre- and post-treatment MRI-measured liver fat content and total body fat via dual energy x-rayabsorptiometry (DEXA) will be compared. The primary end point of successful therapy will be an improvement in hepatic steatosis as measured by MRI. Secondary endpoints will be an improvement in total body fat, metabolic profile, and liver biochemistry
Latest
news:
