Galmed Pharmaceuticals (Galmed) has signed an investigator initiated clinical trial agreement with Icahn School of Medicine at Mount Sinai, US, for a Phase IIa trial to evaluate the effect of Aramchol in combination with vitamin D to treat Fibrotic Nonalcoholic Fatty Liver Disease (NAFLD) patients.
The study, entitled ‘A Placebo-controlled Single-blinded Study of Aramchol with Supplemental Vitamin D in Patients with Vitamin D Deficiency and Nonalcoholic Fatty Liver Disease (NAFLD) and Fibrosis’, will enrol 80 patients with NAFLD and fibrosis.
To be led by principal investigator Dr Andrea Branch, a professor of medicine in Icahn School of Medicine, the study will be performed at Icahn School of Medicine at Mount Sinai and an additional centre in Israel.
The trial is expected to be completed in the first half of 2018.
Galmed has already filed a patent application for the composition of matter patent on the new combination therapy.
The study design includes four dose alternatives, Aramchol 400mgs, vitamin D, Aramchol 400mgs and vitamin D in combination, and Placebo, administrated for 24 weeks, followed by a four week follow-up period.
The study’s primary endpoint is the change in liver stiffness (baseline to end of treatment), measured by Magnetic Resonance Elastography (MRE).
Secondary endpoints cover changes in the intrahepatic fat content (measured by MRI and FibroScan / CAP), and other metabolic parameters.
Dr Branch said: "The liver is a key regulator of lipid metabolism and frequently becomes inflamed and damaged in patients with metabolic abnormalities, including type-2 diabetes and obesity.
"Aramchol, a bile acid-fatty acid conjugate, was previously shown to decrease liver fat. Vitamin D3 is a key regulatory hormone that reduces inflammation and improves the barrier function of the intestine, potentially protecting the liver from harmful bacterial products that would otherwise reach the liver and cause injury.
"In addition to the innovative dual therapy, the trial has several more novel features. It will be open to patients with NASH and well-compensated liver cirrhosis (unlike many trials that exclude these patients), as well as to patients with less extensive liver damage, and it will not require a liver biopsy for participation."
Galmed stated that it would continue to investigate compounds complementary to Aramchol, including safe, FDA-approved compounds reposition to treat fibrosis.