Reuters Health Information: Israeli company Galmed gets positive trial results for liver drug
Israeli company Galmed gets positive trial results for liver drug
Last Updated: 2018-06-12
By Reuters Staff
TEL AVIV (Reuters) - Galmed Pharmaceuticals said on Tuesday patients in a mid-stage trial for its treatment for non-alcoholic steatohepatitis (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. Aramchol is an oral, once-daily, liver-targeted SCD1 modulator.
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.
According to a company statement, "Aramchol (arachidyl amido cholanoic acid) is a novel fatty acid bile acid conjugate, inducing beneficial modulation of intra-hepatic lipid metabolism. Aramchol's ability to modulate hepatic lipid metabolism was discovered and validated in animal models, demonstrating down regulation of the three key pathologies of NASH; steatosis, inflammation and fibrosis. The effect of Aramchol on fibrosis is mediated by down regulation of steatosis and directly on human collagen producing cells. Aramchol has been granted by the FDA Fast Track designation status for the treatment of NASH."