Akero Therapeutics to Present EFX Data at EASL Congress 2024

Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage biotechnology firm dedicated to developing transformative treatments for severe metabolic diseases, has unveiled important data regarding its leading drug candidate, efruxifermin (EFX). These findings were presented at the 2024 European Association for the Study of the Liver (EASL) Congress in Milan, Italy. The presentations, which will later be accessible on Akero’s website, highlight significant advancements in treating metabolic dysfunction-associated steatohepatitis (MASH), particularly for patients with fibrosis stages 2 and 3 (F2-F3).

Key data from the HARMONY Phase 2b study were prominently featured during the event. This study assessed the efficacy and safety of EFX over 96 weeks. Initially, at the 24-week mark, the primary endpoint was met as both 50 mg and 28 mg doses of EFX achieved ≥1-stage improvement in fibrosis without worsening MASH, with response rates of 41% and 39% respectively, compared to 20% for the placebo group. Remarkably, by week 96, the response rates rose to 75% for the 50 mg group and 46% for the 28 mg group, significantly outperforming the placebo group, which recorded a 24% response rate.

Further substantial improvements were observed in secondary histology endpoints at week 96. Patients treated with 50 mg and 28 mg EFX experienced a 2-stage improvement in fibrosis rates of 36% and 31%, respectively, far exceeding the 3% improvement seen in the placebo group. The study revealed that the positive effects of EFX were not only sustained but also expanded with prolonged treatment, with the most pronounced benefits observed in the 50 mg EFX group. Over 80% of EFX-treated patients who showed fibrosis improvement at week 24 maintained this improvement through week 96, whereas more than half of the placebo responders at week 24 did not sustain their response.

EFX also demonstrated efficacy in patients with baseline F3 fibrosis, indicating potential for treating more advanced stages associated with higher risks of progression to cirrhosis. The safety profile of EFX was encouraging, with no signs of liver injury or severe adverse events. The most common side effects were transient Grade 1 or 2 gastrointestinal events, consistent with observations from the first 24 weeks.

Additionally, a poster presentation detailed a post-hoc analysis of biomarkers related to collagen synthesis and degradation, enhancing understanding of EFX's impact on liver fibrosis and extracellular matrix (ECM) remodeling. EFX treatment was linked to beneficial changes in ECM, reducing interstitial collagens and regenerating structural collagens, alongside decreased markers of liver injury.

These robust findings underscore EFX's potential to improve metabolic and liver health, marking it as a promising candidate in the MASH treatment landscape. Akero's President and CEO, Dr. Andrew Cheng, expressed optimism, highlighting the unprecedented sustained response rates and the significant improvement in fibrosis stages without worsening MASH as key differentiators for EFX.

The HARMONY study, a multicenter, double-blind, placebo-controlled clinical trial, enrolled 128 adult patients with biopsy-confirmed MASH and fibrosis stages F2 or F3. The primary endpoint was achieving ≥1-stage fibrosis improvement without MASH worsening at week 24, with an extension to 96 weeks for secondary endpoints, including further fibrosis improvement and resolution markers, safety, and tolerability.

Akero’s lead candidate, EFX, is designed to mimic the endogenous hormone FGF21, targeting the complex, multi-system disease state of MASH through weekly subcutaneous dosing. EFX's potential benefits include reduced liver fat and inflammation, enhanced insulin sensitivity, and improved lipid profiles, addressing cardiovascular risks.

Akero continues to advance EFX through several clinical trials, including the ongoing SYMMETRY study in patients with compensated cirrhosis due to MASH and the Phase 3 SYNCHRONY Histology and Real-World studies. A new SYNCHRONY Outcomes study is slated to begin in the second quarter of 2024, consolidating the foundation laid by earlier Phase 2b trials.

These developments reinforce Akero's commitment to addressing serious metabolic disorders, with EFX promising significant advancements in treating MASH and improving patient outcomes.