Business
Galmed Announces Positive Results from First 16 Patients in Open-Label Part of ARMOR Study
-- Treatment with Aramchol 300mg BID reduced fibrosis progression measured by histology in 15 out of the 16 patients completed as of data cutoff -- -- 50% of
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":"-- Treatment with Aramchol 300mg BID reduced fibrosis progression measured by histology in 15 out of the 16 patients completed as of data cutoff --\n -- 50% of the 16 patients showed fibrosis improvement by ≥1 stage, seen as early as 24 weeks --\n --Data demonstrates that treatment with Aramchol 300mg BID resulted in clinically significant greater histological improvement than observed previously with Aramchol 600mg QD --\n -- Data add to body of evidence from prior studies demonstrating the benefit of Aramchol for patients with histologically confirmed NASH and fibrosis and provides clinical support for the hypothesis that a higher daily dose will result in improved clinical benefit --\n -- Data will be presented at a late-breaking poster presentation 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 from November 12-15, 2021 --\n Galmed's management team will host a conference call and webcast to provide an update on current developments with respect to its clinical programs for Aramchol including NASH Expert Insights on the ongoing Open-Label Part of the ARMOR study, and to discuss financial results for the quarter ended September 30, 2021 on November 8th @ 8.30am Eastern Time\n\n\nTEL AVIV, Israel, Nov. 1, 2021 /PRNewswire/ -- 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. \nEnd 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.\nA 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 Experi...