AKRO - Akero Therapeutics Presents Poster and Late-breaking Oral Presentation on EFX at the EASL Congress 2024 | Benzinga
SOUTH SAN FRANCISCO, Calif., June 08, 2024 (GLOBE NEWSWIRE) -- Akero Therapeutics, Inc. (NASDAQ:AKRO), a clinical-stage biotechnology company developing transformational treatments for patients with serious metabolic disorders marked by high unmet medical need, today announced two presentations featuring its lead product candidate efruxifermin (EFX) at the European Association for the Study of the Liver (EASL) Congress 2024, in Milan, Italy. The presentations will also be available on Akero's website following the meeting.
A late-breaking oral presentation will feature 96-week data from HARMONY, a Phase 2b study evaluating the efficacy and safety of EFX in patients with metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2–F3). The study met its primary endpoint of ?1-stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50 mg EFX (41%, p<0.05) and 28 mg EFX (39%, p<0.05) dose groups, compared to 20% for the placebo group. At Week 96, response rates for this endpoint increased to 75% (p<0.001) for 50 mg EFX and 46% (p=0.07) for 28 mg EFX, vs 24% for placebo.
The study also met additional histology endpoints at week 96. Notably 36% (p<0.01) and 31% (p<0.01) of patients treated with 50 mg EFX and 28 mg EFX, respectively, had a 2-stage improvement in fibrosis without worsening of MASH, more than 10-fold the placebo rate of 3%.
A comparison of week 96 with week 24 results showed that treatment response among EFX-treated patients was both sustained and expanded with longer treatment, particularly among the 50 mg EFX group. More than 80% of all EFX-treated patients with improved fibrosis at week 24 experienced sustained improvement through week 96, reflecting maintained reductions in markers of liver injury and fibrosis, whereas more than half of placebo responders at week 24 failed to maintain their response. In addition, 63% of patients treated with EFX 50 mg who were non-responders at week 24 experienced an improvement in fibrosis and no worsening of MASH with the benefit of treatment for 96 weeks, three times the placebo rate of 21%. In a subset of patients with baseline F3, treatment with EFX was associated with response on fibrosis improvement similar to the overall study population of F2 and F3 patients treated with EFX, showing the potential for treating more-advanced fibrosis, associated with increased risk of progression to cirrhosis. Results from the HARMONY study indicate EFX was generally well tolerated, with no liver injury or decompensation events, and no deaths. The most frequent adverse events (AEs) were transient Grade 1 or 2 gastrointestinal events, with an overall event profile similar to what was observed during the first 24 weeks.
A poster presentation will present results from a post-hoc analysis of key biomarkers associated with collagen synthesis and degradation. These data improve our understanding of EFX pharmacology and its effects on extracellular matrix (ECM) remodeling in the liver and fibrosis improvement. EFX treatment was associated with significant changes in the ECM toward a potentially beneficial phenotype, with decreased ...