- The experimental drug efruxifermin showed it can help patients with a type of liver disease to reverse scarring of the organ without worsening the condition in a keenly awaited mid-stage trial.
- This drug is being studied in patients with severe scarring or cirrhosis due to a type of fatty liver disease known as metabolic dysfunction-associated steatohepatitis (MASH).
- Ticker: AKRO
Akero Therapeutics reports preliminary topline results showing statistically significant reversal of compensated cirrhosis due to MASH-by both completer and ITT analyses-at Week 96 in phase 2b symmetry study
- Co released preliminary topline week 96 results from SYMMETRY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with biopsy-confirmed compensated cirrhosis (F4), Child-Pugh Class A, due to metabolic dysfunction-associated steatohepatitis (MASH). Among patients with baseline and week 96 biopsies, 39% of patients treated with 50mg EFX experienced reversal of cirrhosis with no worsening of MASH, compared to 15% for placebo. In the Intent to Treat (ITT) population, with all missing week 96 biopsies treated as failures, 29% of patients in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH, compared to approximately 12% in the placebo group.
- With more than a doubling of effect size from weeks 36 to 96 in the 50mg group (from 10% to 24%), the SYMMETRY study underscores the benefit of longer EFX treatment for patients with compensated cirrhosis (F4).
- In a subgroup of patients with baseline and week 96 biopsies who were not taking GLP-1 at baseline, 45% in the 50mg EFX group experienced reversal of cirrhosis with no worsening of MASH compared to 17% for placebo, suggesting that the observed reversal of cirrhosis was not attributable to GLP-1 therapy.
