Akero Therapeutics' MASH Trial Success Sends Stock Soaring

Akero Therapeutics has reported groundbreaking results from its extended 96-week analysis of a phase 2b trial for efruxifermin (EFX) in metabolic dysfunction-associated steatohepatitis (MASH) patients with compensated cirrhosis. The announcement has led to a dramatic surge in the company's stock price, nearly doubling in premarket trading.

Statistically Significant Results in Key Analyses

The trial, which initially missed its primary endpoint at 36 weeks in 2023, has now demonstrated statistically significant improvements in two crucial 96-week analyses. The intention-to-treat (ITT) analysis showed that 29% of patients on the high dose of EFX experienced reversal of cirrhosis without worsening of MASH, compared to 12% for placebo (p=0.031). In the completer analysis, which excluded patients without Week 96 biopsies, the response rates were even more impressive at 39% for the high-dose EFX group versus 15% for placebo (p=0.009).

These results are particularly noteworthy as they represent the first time a treatment has shown reversal of cirrhosis in MASH patients, a goal that has long eluded researchers in the field. Analysts from Evercore ISI have hailed the data as "transformational," suggesting that Akero's phase 3 trial is now significantly derisked.

Deepening Effects Over Time

The extended analysis revealed that the efficacy of EFX appears to increase over time. While there was only a 10 percentage point difference between EFX and placebo at 36 weeks, this gap widened to 24 percentage points by Week 96. This trend adds weight to Akero's argument that the drug's effects on compensated cirrhosis become more pronounced with longer treatment duration.

Implications for GLP-1 Therapies

Akero also presented a subgroup analysis examining EFX's performance in patients not taking GLP-1 drugs such as Eli Lilly's Zepbound and Novo Nordisk's Wegovy. In this cohort, the response rates were 45% for EFX and 17% for placebo, leading Akero to suggest that the observed cirrhosis reversal was not attributable to GLP-1 therapy. This finding could have significant implications for the positioning of EFX in the evolving landscape of MASH treatments.

Market Response and Future Outlook

The positive data has had a dramatic effect on Akero's market position, with shares jumping approximately 100% to nearly $54 in premarket trading. This surge brings the stock price close to levels last seen before the initial phase 2b primary endpoint miss in 2023.

Akero is currently conducting three late-phase studies to evaluate EFX in different subpopulations of MASH patients, including a phase 3 trial in compensated cirrhosis patients that began dosing last year. The company's progress and the latest data have sparked speculation about its potential as a buyout target, adding further interest to its stock performance.

As the pharmaceutical industry continues to search for effective treatments for MASH, Akero's EFX has now positioned itself as a leading candidate, potentially offering hope to patients with this challenging liver condition.