Akero (AKRO.US) positive results in drug trial for fatty liver disease, pre-market surges by 20%.

Akero Therapeutics (AKRO.US) announced that a Phase 2b study has shown positive preliminary results at week 96, evaluating the efficacy and safety of their lead candidate, Efruxifermin, in patients with non-alcoholic steatohepatitis (NASH) with metabolic dysfunction associated with liver cirrhosis, fibrosis stage 2 or 3. Following the news release, Akero's stock surged, rising by as much as 97.81%, and at the time of writing, the company was up 21.54% in premarket trading, at $33.8. The clinical-stage company reported that the study met the primary endpoint of improvement at 24 weeks, with both the 50mg and 28mg doses of Efruxifermin showing improvement in fibrosis without worsening of liver histology, compared to only 20% in the placebo group. By week 96, the response rates for the primary endpoint in the 50mg and 28mg Efruxifermin groups increased to 75% and 46%, respectively, compared to 24% in the placebo group. The study also met other histological endpoints at week 96, with 36% and 31% of patients receiving treatment with 50mg and 28mg of Efruxifermin, respectively, showing improvement in fibrosis stage 2 without worsening of liver histology, compared to only 3% in the placebo group. Reportedly, Efruxifermin was well tolerated with no reported deaths and 15 cases of serious adverse events, with adverse reactions relatively balanced across the dose groups. The study aims to conduct a second liver biopsy after 96 weeks of treatment, with results expected in the first quarter of 2025.