Akero Therapeutics Reports Breakthrough in MASH Cirrhosis Treatment

SOUTH SAN FRANCISCO, Calif. — Akero Therapeutics, Inc. (NASDAQ: AKRO) announced groundbreaking results from its Phase 2b SYMMETRY study, revealing that its drug candidate efruxifermin (EFX) significantly reversed compensated cirrhosis caused by metabolic dysfunction-associated steatohepatitis (MASH). The findings, released on January 27, 2025, mark a potential turning point in treating this severe liver condition.

In the study, 39% of patients treated with 50mg EFX showed at least a one-stage improvement in fibrosis without worsening MASH, compared to 15% in the placebo group. The Intent to Treat (ITT) analysis, which included all randomized patients, showed a 29% improvement rate for the 50mg EFX group versus 12% for placebo. The results were particularly pronounced in patients not taking GLP-1 therapy, with 45% of the 50mg EFX group achieving cirrhosis reversal compared to 17% for placebo.

“Until today, we’ve not had the prospect of an effective treatment for compensated cirrhosis due to MASH, which is associated with high rates of short-term morbidity and mortality,” said Dr. Mazen Nourredin, principal investigator for the SYMMETRY study and a professor at Houston Methodist Hospital. “Now we have reason to be optimistic about the future potential of EFX as a much-needed treatment for cirrhosis, if approved.”

EFX, a once-weekly subcutaneous treatment, was generally well-tolerated, with most adverse events being mild to moderate gastrointestinal issues. No deaths or serious adverse events were attributed to the drug. The study also noted improvements in noninvasive measures of liver fibrosis and injury, including liver stiffness and enzyme levels.

The SYMMETRY study enrolled 182 patients with biopsy-confirmed compensated cirrhosis due to MASH, a condition projected to affect 3 million Americans by 2030. MASH cirrhosis is the fastest-growing cause of liver transplants and liver cancer in the U.S. and Europe.

Akero Therapeutics plans to continue evaluating EFX in its ongoing Phase 3 SYNCHRONY Outcomes study. “We believe today’s first-ever public report of reversal of cirrhosis due to MASH sets EFX apart from other approved or investigational treatments,” said Dr. Andrew Cheng, Akero’s president and CEO.