Akero Therapeutics Inc (NASDAQ: AKRO) has seen a surge in its stock price after releasing preliminary topline week 96 results from the HARMONY Phase 2b study of its lead product candidate efruxifermin (EFX) for pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3).
The study, which previously met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment, showed impressive results at week 96. The response rates on this endpoint increased to 75% for the 50mg EFX group and 46% for the 28mg EFX group, compared to 24% for placebo.
Additionally, the study also met additional histology endpoints at week 96, with a significant number of patients experiencing a 2-stage improvement in fibrosis without worsening of MASH. The placebo-adjusted effect size on fibrosis improvement without worsening of MASH more than doubled between week 24 and week 96 for the 50mg EFX group.
In a subset of patients at higher risk of progression to cirrhosis, a substantial number of patients in the 50mg EFX and 28mg EFX groups experienced at least a one-stage improvement in fibrosis without worsening of MASH, highlighting the potential of EFX in treating this condition.
The study also showed sustained response and broader fibrosis improvement without worsening of MASH, particularly at the 50mg EFX dose. EFX was reported to be generally well-tolerated, with no deaths reported and a balanced number of serious adverse events across dose groups.
In contrast, in October 2023, Akero reported disappointing results for the SYMMETRY Phase 2b trial in patients with compensated cirrhosis (F4) due to MASH, Child-Pugh class A. However, the results from the second biopsy after 96 weeks of treatment are on track to be reported in the first quarter of 2025.
Overall, the positive results from the HARMONY study have boosted investor confidence in Akero Therapeutics, leading to a significant increase in its stock price. As the company continues to advance its clinical trials and develop potential treatments for metabolic disorders, it remains a key player in the biopharmaceutical industry.
