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Galmed Announces New Positive Data from Ongoing ARMOR Study Open Label Part Showing Clinically Significant Effect on Fibrosis Improvement
-- Updated liver histology data from first 20 patients show 60% fibrosis improvement by at least 1 stage as early as 24 weeks, data will be presented at
About this update from Galmed Pharmaceuticals Ltd.
[{"type":"text","content":"\n -- Updated liver histology data from first 20 patients show 60% fibrosis improvement by at least 1 stage as early as 24 weeks, data will be presented at AASLD Late Breaker Presentations --\n-- Statistically significant reductions in biomarkers associated with liver fibrosis including ALT, AST, Fib-4 and ProC-3 was also observed in ~ 50 patients --\n-- Results are an early indication that higher dose of Aramchol could provide statistically and clinically meaningful effect on fibrosis in the double-blind placebo controlled regulatory part for submission of an NDA under Sub-part H--\nGalmed'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 Today @ 8.30am Eastern Time\n TEL AVIV, Israel, Nov. 8, 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 histology and biomarkers analyses in the ongoing Open-Label Part of the ARMOR Phase 3 study. \n\n \n \n \n \n \n \n\n \nGalmed previously announced a substantial effect on fibrosis improvement based on histology, in the 16 first patients from the ongoing Open-Label Part of the ARMOR study. New analyses of biomarkers corroborate this effect showing statistically significant reductions in biomarkers associated with liver fibrosis including ALT, AST, Fib-4 and ProC-3. Reductions of a similar magnitude are seen in a cohort of the first 20 patients for which paired biopsy have been analyzed (Late breaker AASLD Cohort N=20) and a cohort of 50 patients for which biomarker data was analyzed (ARCON Cohort N=50) based on all available data (N=139). Aramchol continues to show excellent safety and tolerability profile. Data support that higher dose of Aramchol could provide statistically and clinically meaningful effect on fibrosis in the upcoming double-blind placebo controlled part for submission of the ARMOR study to support an NDA under Sub-part H. \nResults support discussions with FDA to potentially allow a smaller and shorter double-blind placebo control histology-based part ...