Akero Therapeutics, Inc. announced 96-week results from the Phase 2b HARMONY trial in The Lancet. Results showed that participants treated with EFX exhibited improvements in fibrosis and MASH, with almost one-third experiencing near complete disease reversal. EFX also improved markers of liver injury and metabolic health. In the 50mg EFX group, 49% achieved at least one stage fibrosis improvement without MASH worsening, compared to 19% for placebo. EFX was generally well tolerated, with mild to moderate gastrointestinal events being the most frequent adverse effects. EFX is currently being evaluated in three Phase 3 studies for MASH.

The HARMONY trial was a Phase 2b study that evaluated EFX in adults with MASH and fibrosis stage 2 or 3. Results showed significant improvements in fibrosis and MASH in EFX-treated participants compared to placebo. Secondary endpoints were also met, with 40% and 37% of participants achieving MASH resolution without fibrosis worsening in the 28mg and 50mg EFX groups, respectively. Analysis also showed sustained response in the 50mg EFX group, with most week 24 responders maintaining their status at week 96. EFX is currently being evaluated in Phase 3 clinical trials.

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