Galmed Pharmaceuticals Ltd. said a certain dose of its Aramchol drug met the main goal of reducing liver fat in patients with a liver disease in a midstage trial.
The phase 2b study, named Arrest, was conducted in 247 overweight or obese patients with biopsy-proven nonalcoholic steatohepatitis, or NASH, and had prediabetes or type 2 diabetes.
NASH, the most severe form of nonalcoholic fatty liver disease, is characterized by the abnormal accumulation of fat in the liver and in some cases could progress to more serious diseases such as advanced scarring, irreversible damage, liver failure or liver cancer.
Patients in the study were treated with either a 400-milligram dose or a 600-milligram dose of Aramchol or placebo. Based on the results, 47% of patients on the higher dose showed a liver fat reduction in contrast to placebo's 24.4%.
Additional biopsy results showed that 16.7% of the patients treated with Aramchol's 600-milligram dose had symptoms of their disease resolved without a worsening in scarring, compared to placebo's 5.0%; while 19.2% of patients achieved NASH resolution, compared to 7.5% on placebo.
Furthermore, 29.5% of the patient group who received the higher dose saw at least a 1-point improvement in their liver scarring without the NASH worsening, versus 17.5% for placebo.
The company noted that the biopsy results may be used as the main goal of a phase 3 trial. The results of the late-stage trial will then be used to file a marketing application with the U.S. Food and Drug Administration.
Galmed's President and CEO Allen Baharaff said the company will meet with regulators as soon as possible to discuss the design of the phase 3 study.
