Galmed Pharmaceuticals Ltd (Nasdaq: GLMD), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases, on Monday reported results from the first 16 patients in the Open-Label Part of the ARMOR Phase 3 study who underwent a scheduled post-baseline biopsy.
The company said that end of treatment biopsies were performed for eight patients at 24 weeks, six at 48 weeks and two at 72 weeks. Treatment with Aramchol reduced fibrosis progression in 15 out of the 16 patients. Eight out of the 16 patients (50%) showed fibrosis improvement by ≥1 stage (four of eight after 24 weeks, three of six after 48 weeks and one of two after 72 weeks). In three patients (19%), fibrosis was reduced by two points. In seven of 16 (44%) patients there was fibrosis improvement without worsening of NASH. Aramchol continues to show good safety and tolerability.
This new data from Galmed's ARMOR Phase 3 Open-Label Part will be presented at The Liver Meeting Digital Experience 2021, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will be held form 12 to 15 November 2021.
Prof Scott Friedman MD, Dean for Therapeutic Discovery, Fishberg Professor of Medicine and Pharmacologic Sciences at Mount Sinai was quoted as stating: "These most recent findings add to the growing evidence of likely efficacy of Aramchol in NASH. Combined with the previous results indicating a direct antifibrotic activity of this agent towards fibrogenic cells, these new data are cause for optimism as we await further Phase 3 results. "
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