Galmed reports results from Open-Label Part of the ARMOR study

Galmed reported full results from the Open-Label Part of the ARMOR study corroborating effects of Aramchol across all efficacy parameters. The study enrolled 157 subjects with biopsy-proven NASH randomized 1:1:1 into three groups differing in the timing of the post-baseline liver biopsy (Week 24, Week 48, and Week 72). Fifty-one (51) subjects underwent post-baseline biopsies prior to study discontinuation (28 subjects at less than48 weeks and 23 subjects at greater than or equal to48 weeks). The study was designed to assess the safety, pharmacokinetics and efficacy kinetics as a function of treatment duration. Three independent pathologists and three different histopathology reading methodologies were used to assess the antifibrotic effect of Aramchol: fibrosis stage based on NASH CRN; ranked assessment (improvement/worsening/stable) of paired (pre- and post-baseline) biopsies, blinded to sequence; and an automated and continuous score of Fibrosis Composite Severity, using FibroNest, a quantitative AI digital pathology image analysis method. Noninvasive tests (NITs) included imaging (fibroscan) and biomarkers (liver enzymes, FIB-4, Pro-C3 and ELF). Aramchol treatment resulted in a high proportion of subjects showing fibrosis improvement based on all three biopsy reading methodologies, with a larger treatment effect with longer duration of therapy. Following a treatment duration of 48 weeks or more, improvement in fibrosis was demonstrated in 39% of subjects according to NASH CRN and 61% of subjects according to ranked assessment. At Week 48 AI demonstrated fibrosis improvement in 100% of subjects when responders were defined by an absolute reduction of the FCS score greater than0.3, 65% when responders were defined by a relative reduction of greater than25%, and a statistically significant reduction from baseline in mean FCS score (pless than0.0001). NASH resolution without worsening of fibrosis was demonstrated in 26.5% of subjects. Fibroscan, ALT, AST, and FIB4 were analyzed using MMRM, based on all subjects (N=154). Fibroscan results were consistent, with an improvement in fibrosis showing a mean absolute reduction from baseline to week 72 of 2.5 kPa (pless than0.0001). At Week 72, ALT was reduced by 22 U/L (pless than0.0001), AST was reduced by 18 U/L (pless than0.0001), and FIB-4 was reduced by 0.30 (pless than0.0001). Pro-C3 and ELF were analyzed for 43 subjects at week 24 showing reduction in both Pro-C3 levels (pless than0.0001) and ELF (p=0.0038). The Open Label part demonstrated the good safety profile of Aramchol 300mg BID including long-term follow up. The incidence of serious adverse events was consistent with the population (10.4%) and early discontinuation rates due to adverse events were low (4.5%).