Akero's MASH Drug Shows Promise in Reversing Liver Cirrhosis, Boosting Industry Outlook

Akero Therapeutics has made significant strides in the treatment of metabolic dysfunction-associated steatohepatitis (MASH), with its lead candidate efruxifermin demonstrating impressive results in reversing liver cirrhosis. The biotechnology company's announcement of positive long-term data from its Phase IIb SYMMETRY trial has not only revitalized investor confidence but also raised hopes for patients suffering from advanced liver disease.

Efruxifermin's Breakthrough in Cirrhosis Reversal

Efruxifermin, an engineered Fc-FGF21 fusion protein, has shown a remarkable ability to improve liver fibrosis in patients with cirrhosis due to MASH. After 96 weeks of treatment, the drug demonstrated a 24% benefit on fibrosis reduction over placebo. Patients receiving the highest dose of 50 mg experienced a 39% improvement in liver fibrosis compared to a 15% improvement in the placebo group.

The results are particularly significant given the poor prognosis for MASH-associated cirrhosis patients, who face a 50% five-year mortality rate. Catriona Yale, chief development officer at Akero, emphasized the importance of these findings, stating, "Longer dosing matters for this drug."

Clinical Trial Details and Patient Outcomes

The SYMMETRY study's long-term data revealed that 29% of participants receiving the highest dose of efruxifermin experienced improvement in liver scarring of at least one stage without MASH worsening, compared to 12% in the placebo group. In a subgroup analysis of patients with liver biopsy results at both baseline and week 96, the improvement was even more pronounced, with 39% of high-dose recipients showing improved liver scarring without MASH worsening, versus 15% in the placebo group.

Interestingly, a subgroup of patients confirmed not to be taking GLP-1 medications saw a 45% improvement compared to 17% in the placebo arm, suggesting efruxifermin's effectiveness independent of GLP-1 therapy.

Market Impact and Industry Implications

The announcement of efruxifermin's success had an immediate and dramatic effect on Akero's stock, which surged by 115% in early trading following the news. The positive results also had a ripple effect on the broader MASH treatment landscape, with shares of competitor 89bio, which is developing a similar drug, rising by up to 50%.

Analysts have responded enthusiastically to the data, with Jefferies calling it a "homerun" and stating that it "further boosts confidence in Phase III which is now very de-risked." The results are particularly significant as they represent the first compound to show a significant reversal of cirrhosis due to MASH in clinical testing.

While the FDA approved the first treatment for MASH in March 2024 with Madrigal Pharmaceuticals' Rezdiffra, that drug is intended for less advanced liver disease. Efruxifermin's potential in treating more advanced, stage 4 patients could fill a critical gap in the treatment landscape.