Galmed reports 52-week results from Phase 2b ARREST study
Galmed (GLMD) announced top-line, 52-week results from the global Phase 2b ARREST study. In the ARREST study, patients underwent MRS and biopsy at baseline and week 52, which were centrally read, blinded to treatment allocation.
The primary endpoint of the study was the change from baseline to end of study in liver triglycerides ratio as measured by MRS (Aramchol 600mg vs. placebo).
Secondary endpoints, demonstrated through biopsy, included fibrosis improvement by at least one stage or more without worsening of NASH (defined by an increase of inflammation and or ballooning) and NASH resolution (defined by ballooning score 0 and inflammation score 0-1 at termination) without worsening of fibrosis.
Other secondary endpoints included improvement (2 points or more) in NASH activity index, as measured by NAS or SAF, without worsening fibrosis and change in baseline to week 52/termination in ALT. 247 patients with biopsy-proven NASH who were overweight or obese and had pre-diabetes or type II diabetes mellitus were randomized in a ratio of 2:2:1 (600 mg, 400 mg and placebo).
Baseline histology of enrolled patients demonstrated a population with advanced disease, with 60% having stage 2 and 3 fibrosis and 70% having NAS greater than or equal to 5 at baseline.
Results from the study showed a statistically significant reduction in liver fat by MRS with Aramchol 400mg vs. placebo and not with 600mg.
Further, analysis of MRS responders defined by a reduction of greater than or equal to 5% absolute change from baseline demonstrated a clinically and statistically significant effect of Aramchol 600 mg vs placebo.
Results for the two biopsy endpoints, which may currently constitute a primary endpoint for a Phase 3 trial to support an FDA marketing application, demonstrated the following: (i) significantly more patients treated with Aramchol 600mg vs. placebo achieved NASH resolution without worsening of fibrosis (16.7% vs. 5.0%; p=0.0514) and NASH resolution; and (ii) a higher proportion of patients showed at least one-point improvement in fibrosis score without worsening of NASH in Aramchol 600 mg vs. placebo.
Statistically significant reductions in live enzymes alanine transaminase and aspartate transaminase were demonstrated in both Aramchol arms vs. placebo, respectively. Secondary endpoints based on NAS and SAF activity score, greater than or equal to 2 points improvement, show a higher proportion of patients with improvement in the Aramchol arms.
At 52 weeks of treatment, Aramchol continues to show a favorable safety and tolerability profile. Serious Adverse Events were reported in 12.5%, 8.9% and 9.2% of patients in placebo, Aramchol 400mg and 600mg arms, respectively.
No clustering of event type or atypical events for the studied population were reported in either Aramchol arms.
Early terminations due to adverse events occurred in 4.2%, 3.0% and 4.1% in placebo, Aramchol 400 mg and 600 mg arms, respectively.
GLMD closed at $7.05, it last traded at $18.65.
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