TEL AVIV (Reuters) - Galmed Pharmaceuticals said on Tuesday patients in a mid-stage trial for its treatment for NASH, a fatty liver disease linked to obesity, showed a statistically significant reduction in liver fat.
The results will allow Galmed to meet with regulators as soon as possible and discuss a pivotal Phase 3 study design, Galmed CEO Allen Baharaff said.
The company’s shares were up 220 percent at $22.42 in premarket trade on Nasdaq.
Patients in the Phase 2b study of Galmed’s drug Aramchol had magnetic resonance spectroscopy (MRS) and biopsy at the start of the study and again after 52 weeks. Galmed said data strongly supported the advancement of Aramchol 600 mg to an advanced Phase 3 trial.
Significantly more patients treated with Aramchol 600 mg versus a placebo showed NASH resolution without worsening of fibrosis in the 52-week biopsy, Galmed said.
Statistically significant reductions in liver enzymes ALT and AST were demonstrated in Aramchol 400 mg and 600 mg versus a placebo, it also said.
Reporting by Tova Cohen. Editing by Jane Merriman