Akero Therapeutics Reports Favorable Fibrosis Progress in MASH Trial

Akero Therapeutics has recently unveiled positive interim results from their Phase IIb HARMONY clinical trial, which evaluated the efficacy of their experimental drug, efruxifermin, in treating patients with metabolic dysfunction-associated steatohepatitis (MASH). The 96-week study demonstrated that efruxifermin, an FGF21 analog, significantly improved liver fibrosis in participants.
Among those who received the 50-mg dosage of efruxifermin, a notable 75% experienced at least one stage of fibrosis regression without an exacerbation of MASH, a marked contrast to the 24% improvement observed in the placebo group. This difference was deemed statistically significant, with a p-value well below 0.001.
The 28-mg dose of efruxifermin also showed promise, with 46% of patients achieving a similar level of fibrosis improvement. However, this did not reach statistical significance when compared to the placebo group.
Additionally, the drug met a crucial secondary endpoint in the HARMONY study. It was found that 36% and 31% of patients on the 50-mg and 28-mg doses, respectively, showed a fibrosis improvement of at least two stages. This outcome was not only significantly better than the placebo rate of 3% but was also an impressive tenfold increase.
Akero's CEO, Andrew Cheng, highlighted the drug's potential for sustained fibrosis improvement and its broad applicability across patient groups, particularly with the 50-mg dose. He also mentioned that the company is committed to further evaluating efruxifermin in the Phase III SYNCHRONY program.
Previous data from the HARMONY trial at the 24-week mark showed a one-stage fibrosis improvement in 39% and 41% of patients treated with the 28-mg and 50-mg doses, respectively, with a placebo rate of 20%. The latest findings indicate that efruxifermin's effects on fibrosis improvement are not only substantial but also long-lasting, especially at the higher dosage.
These results are particularly encouraging for Akero, following the disappointment of the Phase IIb SYMMETRY study in October 2023, where efruxifermin failed to outperform the placebo in improving fibrosis without worsening MASH. The new data suggest that with extended exposure, efruxifermin could offer a meaningful treatment option for patients with MASH, potentially leading to a resurgence in the company's fortunes.