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.
Read it here: http://www.chronicliverdisease.org/reuters/article.cfm?article=20180612Other2021305796
Press Release
Galmed's 600 mg Aramchol™ Achieved a Regulatory Approvable Endpoint Showing NASH Resolution Without Worsening of Fibrosis, in NASH Patients, in the Global Phase 2b ARREST 52-Week Study
Data Strongly Support Advancement of Aramchol™ 600mg to Phase 3
TEL AVIV, Israel, June 12, 2018 /PRNewswire/ --
Statistically significant reduction in liver fat was demonstrated by Magnetic Resonance Spectroscopy (MRS) in patients completing 52 weeks of treatment with Aramchol 400mg vs. placebo. Post hoc analysis of MRS responders, defined by a reduction of =5% absolute change from baseline, demonstrated a clinically and statistically significant effect of Aramchol 600mg vs. placebo.
Significantly more patients treated with Aramchol 600mg vs. placebo showed NASH resolution without worsening of fibrosis in the 52-week biopsy, a regulatory approvable endpoint.
A higher proportion of patients with at least one-point improvement in fibrosis score without worsening of NASH was demonstrated in Aramchol 600mg vs. placebo, in the 52-week biopsy, a regulatory approvable endpoint.
Statistically significant reductions in ALT and AST were demonstrated in Aramchol 400mg and 600mg vs. placebo.
Aramchol continues to show favorable safety and tolerability profile.
TEL AVIV, Israel, June 12, 2018 /PRNewswire/ --
Statistically significant reduction in liver fat was demonstrated by Magnetic Resonance Spectroscopy (MRS) in patients completing 52 weeks of treatment with Aramchol 400mg vs. placebo. Post hoc analysis of MRS responders, defined by a reduction of =5% absolute change from baseline, demonstrated a clinically and statistically significant effect of Aramchol 600mg vs. placebo.
Significantly more patients treated with Aramchol 600mg vs. placebo showed NASH resolution without worsening of fibrosis in the 52-week biopsy, a regulatory approvable endpoint.
A higher proportion of patients with at least one-point improvement in fibrosis score without worsening of NASH was demonstrated in Aramchol 600mg vs. placebo, in the 52-week biopsy, a regulatory approvable endpoint.
Statistically significant reductions in ALT and AST were demonstrated in Aramchol 400mg and 600mg vs. placebo.
Aramchol continues to show favorable safety and tolerability profile.
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