ARREST Phase IIb Top-Line 52 weeks results

Below, we are re-publishing with permission the press-release issued by Galmed Pharmaceuticals Ltd. on the 12th of June 2018

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

  • 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.

You can find more information here: http://galmedpharma.investorroom.com/2018-06-12-Galmeds-600-mg-Aramchol-TM-Achieved-a-Regulatory-Approvable-Endpoint-Showing-NASH-Resolution-Without-Worsening-of-Fibrosis-in-NASH-Patients-in-the-Global-Phase-2b-ARREST-52-Week-Study

* The study is conducted in part by Clinical Accelerator

This entry was posted in Central and Eastern Europe, ClinAccel.Net, Clinical Accelerator. Bookmark the permalink.

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