Israeli-based clinical-stage bio-pharmaceutical company Galmed has closed patient enrolment for its Phase IIb ARREST study of Aramchol to treat liver diseases such as non-alcoholic steato-hepatitis (NASH).
Orally administered aramchol is a conjugate of cholic acid and arachidic acid and belongs to synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs).
It partially obstructs activity of Stearoyl Coenzyme A Desaturase 1 (SCD1) in the liver, resulting in a reduced synthesis of fatty acids with a subsequent decrease in storage of triglycerides and other esters of fatty acids, thereby reducing liver fat.
The Phase IIb ARREST study will be conducted as a global, multi-centre, randomised, double blind, placebo-controlled trial, which will test the safety and efficacy of Aramchol while examining 240 patients with NASH who are overweight or obese, and who are pre-diabetic or type-II-diabetic.
The study is primarily focused on achieving reduction in liver fat content measured by magnetic resonance spectroscopy (MRS).
The trial will also explore its secondary histological endpoints of achieving improvement in fibrosis, two-point improvement in NAS (NAFLD Activity Score) and resolution of NASH, as well as assess surrogate metabolic endpoints.
ARREST study global principal investigator Professor Vlad Ratziu said: "The ARREST study is the largest study to date to incorporate both MRI and histology endpoints.
“I expect that Aramchol will demonstrate the effects seen in pre-clinical and clinical studies on the three pathologies of NASH: steatosis, inflammation and fibrosis.”
The study will be conducted for a period of 52 weeks followed up with a 12 weeks phase, with its result expected to be released in the second quarter of 2018.
Image: Micrograph displaying steatohepatitis. Photo: courtesy of Nephron.