Akero Reinforces Phase III FGF21 Analog Candidate with Enhanced Fibrosis Response Rates in MASH Data Update

1. Akero Therapeutics releases additional data from its Phase 2b HARMONY study, supporting the efficacy of its FGF21 analog candidate, efruxifermin (EFX), in treating metabolic dysfunction-associated steatohepatitis (MASH).
2. At 96 weeks, 50mg EFX group showed 75% improvement in fibrosis without worsening of MASH, while the 28mg group achieved 46%; both significantly exceeding the 24% improvement in the placebo group.
3. The study met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment.
4. The response rates on the primary endpoint increased to 75% (p<0.001) for the 50mg EFX group and 46% (p=0.07) for the 28mg EFX group compared to 24% for placebo at week 96. 5. The Phase 2b HARMONY study is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging trial in biopsy-confirmed adult MASH patients with fibrosis stage 2 or 3. 6. Akero's stock price experienced a premarket jump of up to 72% and settled at an 18% increase after the market opened. 7. The drug candidate, efruxifermin, is already in a Phase III program recruiting a variety of MASH patients. 8. The study results suggest that efruxifermin has the potential to deliver substantially higher rates of fibrosis improvement compared to other treatments like resmetirom. 9. Minor changes in bone density were observed in people who received Akero's drug, but these changes were not considered significantly different from what is expected in the study population. These findings indicate that Akero's FGF21 analog, efruxifermin, demonstrates promising fibrosis response rates in the treatment of MASH, potentially positioning it as a leading therapy in the disease space.