FDA clears investigational new drug application of aramchol to treat NASH

The FDA has granted clearance to an investigational new drug application for aramchol to be used in clinical trials to treat nonalcoholic steatohepatitis, according to a press release from Galmed Pharmaceuticals.

Aramchol, a combination of cholic and arachidic acids, is a first in class member of a novel family of synthetic fatty-acid / bile-acid conjugates, according to the release.

"We believe that the IND application clearance serves as an additional validation for our development program and will allow us to perform clinical studies for our primary indication, NASH [nonalcoholic steatohepatitis], as well as additional proof of concept studies of aramchol in the United States in the future," Allen Baharaff, chief executive officer at Galmed, said in the release. "We further believe that the indications we are seeking to address with aramchol are increasingly relevant public health issues as they are major causes of cardiovascular and liver-related morbidity and mortality, with no approved treatment currently available."

As a result of the clearance, Galmed has submitted a request for Fast Track Designation for the drug, which would facilitate the development of the drug and expedite the review process.

In a phase 2a clinical trial, aramchol was effective in reducing liver fat when taken at a dose of 300 mg once-daily for 3 months, according to the release.

Galmed reported it will conduct a phase 2b clinical trial of aramchol in 240 patients with NASH later this year.