Akero Therapeutics Advances Efruxifermin Study for NASH Treatment: A Potential Breakthrough in Liver Health

Akero Therapeutics is conducting a Phase 3 study to assess the safety and efficacy of Efruxifermin in treating non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages 2 or 3. The study includes two experimental groups receiving different doses of EFX (28 mg and 50 mg) and a placebo group for comparison. The study began on December 1, 2023, and recruitment is ongoing. Favorable results could boost investor confidence and Akero's stock performance.

Akero Therapeutics (AKRO) has recently announced an update on its ongoing clinical study evaluating Efruxifermin (EFX) for the treatment of non-cirrhotic nonalcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis stages 2 or 3. The Phase 3 study, titled 'A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis,' aims to assess the safety and efficacy of EFX in patients with NASH/MASH and fibrosis stages 2 or 3.

The study includes two experimental groups receiving different doses of EFX (28 mg and 50 mg) and a placebo group for comparison. EFX is administered via subcutaneous injection and is designed to improve liver health in patients with NASH/MASH. The study employs a quadruple masking approach, ensuring that participants, care providers, investigators, and outcomes assessors are all blinded to the treatment allocations.

The study began on December 1, 2023, and recruitment is ongoing. The last update was submitted on July 29, 2025, indicating progress in the study. The primary completion and estimated completion dates are yet to be announced.

The market implications of this study update could be significant for Akero Therapeutics. Favorable results could boost investor confidence and potentially enhance the company's stock performance. The competitive landscape for NASH treatments is crowded, with several companies developing therapies, making this study's outcomes crucial for Akero's market positioning.

The THR-β agonist market, which includes EFX, is witnessing rapid growth due to the increasing prevalence of metabolic disorders and rare genetic conditions. The approval of REZDIFFRA by the US FDA in March 2024 for the treatment of MASH with moderate to advanced fibrosis has marked a significant milestone in this space [2].

The competitive landscape for THR-β agonists is expected to intensify as multiple companies pursue candidates. Viking Therapeutics, for instance, is developing VK2809, which has shown promising results in clinical trials [2].

Overall, the combination of clinical innovation, unmet medical need, and supportive regulatory momentum will be critical in shaping the dynamics of the THR-β agonist market over the next decade.

References:
[1] https://www.tipranks.com/news/company-announcements/akero-therapeutics-advances-efruxifermin-study-for-nash-treatment
[2] https://www.prnewswire.com/news-releases/thr--agonist-market-on-the-rise-insights-and-projections-upto-2034--delveinsight-302517059.html