Shares of Israel-based Galmed Pharmaceuticals Ltd. (GLMD - Free Report) soared 149.5% after the company announced positive top-line results on its lead candidate, Aramchol, for the treatment of non-alcoholic steatohepatitis (NASH) at 52 weeks.
Consequent of this gain, Galmed shares have gained 94.5% in the last six months compared with the industry’s growth of 8.0%. Shares are up in pre-market trading as well.
Patients enrolled in the phase IIb study, ARREST, underwent Magnetic Resonance Spectroscopy (MRS) and biopsy at baseline and week 52. Patients with biopsy-proven NASH, who were overweight or obese and had pre-diabetes or type II diabetes mellitus, were randomized in a ratio of 2:2:1 (600mg, 400mg and placebo).
The primary endpoint of the study was the change from baseline to end of study, in liver triglycerides ratio as measured by MRS (Aramchol 600mg compared to placebo).
A statistically significant reduction in liver fat was demonstrated by MRS, in patients who had completed 52 weeks of treatment with Aramchol 400mg as compared to placebo. In addition to this, the post hoc analysis of MRS responders (defined by a reduction of ≥5% absolute change from baseline) also demonstrated a clinically and statistically significant effect of Aramchol 600mg compared to placebo.
Moreover, a larger number of patients treated with Aramchol 600mg showed NASH resolution without worsening of fibrosis in the 52-week biopsy. Aramchol 600 mg also resulted in at least one-point improvement in fibrosis score without worsening of NASH, in a higher proportion of patients, as compared to placebo.
Further, statistically significant reductions in live enzymes alanine transaminase (ALT) and aspartate transaminase (AST) were also seen in both Aramchol arms as compared to placebo (p≤0.0002) and (p≤0.001), respectively.
These results indicate that Aramchol 400mg is probably sufficient for fat reduction but, biologically, a higher dose is needed for achieving more stringent histological endpoints, such as NASH resolution and fibrosis reversal. The data strongly support advancing Aramchol 600mg to phase III.
Per estimates, NASH impacts approximately 3-5% of people in the United States and approximately 2-4% globally. NASH is also one of the fastest growing causes of liver cancer and liver transplant in the United States, due to the rise in obesity.
Hence, the successful development and commercialization of Aramchol will be a significant boost for the clinical-stage biopharmaceutical company Galmed, given its potential in the market.
Other companies like Gilead Sciences (GILD - Free Report) , Intercept Pharmaceuticals (ICPT - Free Report) and Novartis (NVS - Free Report) also have promising NASH candidates in their pipelines.
Galmed currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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