Shares of the Israeli biotechnology company Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) surged nearly 150% on Tuesday after the company released its results on the Phase 2B ARREST study.
The study was meant to focus on the development of Galmed’s once per day oral medication Aramchol, for the treatment of the liver disease non-alcoholic steatohepatitis (NASH).
A total of 247 patients with NASH who were overweight or obese with either pre-diabetes or type II diabetes participated in the study.
The patients were then divided into three groups, one which was given 600mg of Aramchol, another that was given 400mg of Aramchol and the third which were given a placebo. Patients went through an MRS and biopsy at the beginning and the end of the study.
The main goal of the study was to see a change in the number of liver triglycerides based on the first MRS and biopsy.
According to Galmed Pharmaceuticals, the results “showed a statistically significant reduction in liver fat by MRS with Aramchol 400mg vs. placebo (p=0.0450) and not with 600mg (p=0.0655).”
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The results will also help to determine the primary endpoint for the Phase 3 trial of Aramchol and be able to provide support for a marketing application from the US Food and Drug Administration (FDA).
According to Vlad Ratziu, a Principal Investigator of the ARREST study and Professor of Hepatology, Sorbonne Université and Hospital Pitié – Salpêtrière, Paris, France, “Aramchol’s favorable safety and tolerability profile [supports] long-term treatment” for NASH.
Galmed CEP and President, Allen Baharaff, has said that the company is “excited with the ARREST results that will enable Galmed to meet with the regulators as soon as possible and discuss the pivotal study design.”
Shares of Galmed rose 149.50% on Tuesday after the trial results were released. The company closed at a share value of $17.59 which is significantly higher than the $7.00 that it closed at on Monday.
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