Akero Therapeutics has shared encouraging preliminary results from a Phase 2b trial assessing the effectiveness and safety of their lead product candidate, efruxifermin. The study focused on patients dealing with pre-cirrhotic metabolic dysfunction-associated steatohepatitis, at fibrosis stage 2 or 3.
Progress Update at Week 96
The clinical-stage company revealed that the study had successfully achieved its primary goal of a 1-stage improvement in fibrosis without MASH deterioration during the initial 24 weeks of treatment. Both the 50mg efruxifermin and 28mg efruxifermin groups demonstrated positive outcomes, with response rates reaching 75% and 46% respectively, in contrast to the 20% rate seen in the placebo group.
Further Achievements
As the trial progressed to week 96, the positive outcomes continued to manifest. The percentage of patients experiencing a 2-stage improvement in fibrosis without MASH worsening was notably higher in the efruxifermin groups at 36% and 31%, compared to just 3% in the placebo group.
Safety and Future Developments
Eefruxifermin proved to be well tolerated overall, with no reported fatalities during the study period. While fifteen serious adverse events were documented, they were evenly distributed across the various dosage groups. The next phase of the study involves a second biopsy after 96 weeks of treatment, with results expected to be unveiled in the first quarter of 2025.
