Akero Therapeutics Advances Phase 3 Study on Efruxifermin for NASH/MASH Cirrhosis

Akero Therapeutics is conducting a Phase 3 clinical study to assess the safety and efficacy of efruxifermin in patients with NASH/MASH-related cirrhosis. The study aims to evaluate the drug's effectiveness and safety in treating a growing health concern with limited treatment options. The study began on September 4, 2024, with the primary completion and estimated completion dates yet to be announced. Successful results could boost confidence in the company's product pipeline and influence Akero Therapeutics' stock performance.

Akero Therapeutics is currently conducting a Phase 3 clinical trial to evaluate the safety and efficacy of efruxifermin in patients with NASH/MASH-related cirrhosis. The study, which began on September 4, 2024, aims to assess the drug's potential in treating this growing health concern, which has limited treatment options. The primary and estimated completion dates are yet to be announced.

The study's success could significantly impact the THR-β agonist market, which is witnessing rapid growth due to the increasing prevalence of metabolic disorders such as MASH and rare genetic conditions like X-ALD. The market size is expected to surge significantly by 2034, driven by the growing global burden of obesity, type 2 diabetes, and metabolic syndromes, which are strongly linked to NASH and NAFLD [1].

Efruxifermin, if successful, could bolster Akero Therapeutics' product pipeline and influence its stock performance. The company's Phase 3 study follows the approval of REZDIFFRA (resmetirom) by the US FDA in March 2024, marking a significant milestone in the THR-β agonist market. REZDIFFRA is the first approved THR-β agonist for treating adults with noncirrhotic MASH and moderate to advanced liver fibrosis (F2-F3) [1].

The competitive landscape in the THR-β agonist market is intensifying, with multiple companies pursuing pipeline candidates. Madrigal Pharmaceuticals, the developer of resmetirom, currently holds a first-mover advantage, but pipeline candidates such as VK2809 (Viking Therapeutics) are showing promising results in clinical trials. The market is expected to grow as more drugs reach late-stage trials and potential approvals. Expansion of indications beyond MASH could broaden the addressable market [1].

Successful results from Akero Therapeutics' Phase 3 study could accelerate the development and approval of efruxifermin, contributing to the market's growth and furthering the therapeutic potential of THR-β agonists. However, the drug's success is not guaranteed, and the market's future will depend on the results of ongoing clinical trials and the evolution of payer acceptance and reimbursement frameworks.

References:
[1] PR Newswire. (2025). THR-β Agonist Market on the Rise: Insights and Projections Upto 2034. Retrieved from https://www.prnewswire.com/news-releases/thr--agonist-market-on-the-rise-insights-and-projections-upto-2034--delveinsight-302517059.html