Benzinga | Nov 1, 2021 10:13AM EDT

Galmed Announces Results From First 16 Patients In Open-Label Part Of ARMOR Study

Galmed Pharmaceuticals Ltd. (NASDAQ:GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today results from the first 16 patients in the Open-Label Part of the ARMOR Phase 3 study who underwent a scheduled post-baseline biopsy.

End of treatment biopsies were performed for 8 patients at 24 weeks, 6 at 48 weeks and 2 at 72 weeks. Altogether treatment with Aramchol reduced fibrosis progression in 15 out of the 16 patients. 8 out of the 16 patients (50%) showed fibrosis improvement by ?1 stage (4 of 8 after 24 weeks, 3 of 6 after 48 weeks and 1 of 2 after 72 weeks). In 3 patients (19%), fibrosis was reduced by 2 points. In 7 of 16 (44%) patients there was fibrosis improvement without worsening of NASH. Aramchol continues to show good safety and tolerability.

A late-breaking poster presentation that includes this new data from Galmed's ARMOR Phase 3 Open-Label Part will be presented at The Liver Meeting Digital Experience(tm) 2021, the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), which will be held form November 12-15, 2021. The abstract covering this new data will also be featured in the December issue of the scientific journal Hepatology and is available on the website of the AASLD.

Prof. Scott Friedman MD, Dean for Therapeutic Discovery, Fishberg Professor of Medicine and Pharmacologic Sciences at Mount Sinai commented: "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. "

Allen Baharaff, President and CEO of Galmed commented: "The data we present today provides initial clinical support for our hypothesis that higher Aramchol exposure results in improved clinical benefit and that a direct anti-fibrotic effect of Aramchol may be manifested as early as 24 weeks." Mr. Baharaff continued: "The findings are a direct outcome of the drug development optimization work we have carried since the completion of the Phase 2b ARREST study in our mission to de-risk our Phase 3 study and bring to the market a leading drug for NASH and fibrosis."