Arun J. Sanyal
Galmed Pharmaceuticals announced the initiation of a late-stage clinical trial to evaluate Aramchol for the treatment of nonalcoholic steatohepatitis with fibrosis, according to a press release.
“Aramchol improves both the metabolic underpinning and lipotoxic stress driving NASH and fibrogenic drive by its effects on stellate cells,” Arun J. Sanyal, MD, principal investigator from the Virginia Commonwealth University, said in the release. “These pleiotropic beneficial effects along with the excellent safety and tolerability profile plus the positive data from earlier phase 2A and 2B trials provide a strong rationale to proceed to a phase 3/4 trial.”
The company previously announced results from the phase 2b trial at The Liver Meeting 2018 in which the investigators observed notable effects on NASH resolution and fibrosis improvement with an excellent safety profile.
The placebo-controlled phase 3/4 study will comprise 2,000 patients with NASH, fibrosis stage 2 or stage 3, overweight or obesity, and prediabetes or type 2 diabetes, enrolled from 185 sites in the U.S., Europe, Latin America and Asia. Treated patients will receive Aramchol 300 mg two times per day for 52 weeks.
“I also look forward to collaborating with colleagues around the world, in the U.S. and Europe but also in areas outside the western World where NASH is highly prevalent,” Vlad Ratziu, MD, principal investigator from the University Hospitals Pitié Salpêtrière in Paris, France, said in the release. “ARREST, a truly global phase 2b trial that recruited worldwide including in Central America and Asia, created much anticipation and interest with Aramchol and should help Galmed drive fast recruitment in a timely manner.” – by Talitha Bennett