Clinical Accelerator are very pleased to announce collaboration with Galmed Pharmaceuticals Ltd. (NASDAQ: GLMD), on conducting a phase IIB clinical trial for the treatment of patients with overweight or obesity and who are pre diabetic or type II diabetic with the liver condition NASH (Non-Alcoholic Steatohepatitis) at seven sites in Georgia and Lithuania.

This trial is a multi-center randomized, double blind, placebo-controlled, dose-ranging Phase IIB study, which is evaluating the efficacy and safety of two doses of Galmed’s novel drug candidate , Aramchol^TM, in NASH overweight or obese patients who are pre-diabetic or already have type II diabetes [1].  The trial is already underway in other participating clinical sites in the USA, Israel, Europe and Latin America. Clinical Accelerator aims to add further impetus to recruitment at four sites in Georgia and three in Lithuania.

Eligible subjects are being enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.  Subject evaluations occur for 10 scheduled visits over one year. After completion of the treatment period, the subjects will be followed for an additional period of 13 weeks without study medication thus making 11 visits in all.

Aramchol , a conjugate of cholic acid and arachidic acid, is a first-in-class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs)  and have been the subject of extensive research over the last 16 years by Galmed’s research team lead by the late Professor Tuvia Gilat.

Aramchol itself has already been shown in a phase IIA clinical study to statistically significantly reduce liver fat content as well as improve metabolic measures associated with fatty liver disease, having a simple once-daily oral dose with no severe adverse effects.

Clinical Accelerator is an independent clinical trial management organisation operating principally in Central and Eastern Europe, Russia, Ukraine and CIS countries.  The organisation offers a broad range of clinical trial services together with dedicated patient enrolment support to worldwide clients in the pharmaceutical, biotechnology, nutraceutical and medical device industries.

Clinical Accelerator always locates GCP-orientated sites with enthusiastic investigators who have the capability to conduct trials to high standards and challenging timelines at competitive rates of remuneration.  Moreover, patients in its areas of operation are usually very happy to participate in clinical trials and research studies, facilitating effective recruitment and retention.

We look forward to a very successful outcome for Galmed’s Phase IIB study and we are delighted to be one of their collaborators in the development of Aramchol, which is showing exciting potential for the treatment of the increasingly common condition of fatty liver disease.

REFERENCES

1. A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH (Aramchol_005) https://clinicaltrials.gov/ct2/show/study/NCT02279524?show_desc=Y#desc
2. galmedpharma.com/about