-- 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 --
-- Statistically significant reductions in biomarkers associated with liver fibrosis including ALT, AST, Fib-4 and ProC-3 was also observed in ~ 50 patients --
-- 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--
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 Today @ 8.30am Eastern Time
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.
Galmed 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.
Results support discussions with FDA to potentially allow a smaller and shorter double-blind placebo control histology-based part to support regulatory submission of an NDA.
A summary of the results is presented below:
Late Breaker AASLD Cohort 1 (N=20) | ARCON Cohort 2 (N~50) | ||||
visit | Change from baseline 3 | p value | Change from baseline 3 | p value | |
ALT | week 24 | -20.88 | |||