Akero Therapeutics Reports Positive Results from Phase 2b Study on Cirrhosis Reversal
Akero Therapeutics (NASDAQ: AKRO) has announced significant topline results from its Phase 2b SYMMETRY study evaluating efruxifermin (EFX) in patients with compensated cirrhosis due to MASH. The study demonstrated statistically significant reversal of cirrhosis at Week 96:
– Among patients with baseline and week 96 biopsies, 39% of the 50mg EFX group showed ≥1 stage improvement in fibrosis with no worsening of MASH, compared to 15% for placebo (24% effect size).
– In the Intent to Treat analysis, 29% of the 50mg EFX group demonstrated improvement, compared to 12% for placebo (17% effect size).
Stronger results were observed in patients not taking GLP-1 at baseline, with 45% showing cirrhosis reversal in the 50mg group versus 17% for placebo. EFX was well-tolerated, with most adverse events being grade 1 or 2 gastrointestinal issues.
Insights on the Study Results:
The SYMMETRY trial results indicate a potential breakthrough in MASH treatment. The high cirrhosis reversal rate of 39% in the 50mg EFX group is unprecedented and holds promise for patients. The doubling of effect size from weeks 36 to 96 suggests increasing benefits with longer treatment duration, crucial for chronic conditions like MASH. The subgroup analysis excluding GLP-1 users showed even more robust results, with a 45% response rate indicating a unique mechanism of action for EFX. Biomarker data supported the histological findings, showing significant improvements in liver stiffness and ELF score.
The safety profile of EFX was favorable, with no serious adverse events related to the drug. This positive benefit-risk profile is essential for a drug intended for chronic use in a large patient population.
These results are particularly significant as compensated cirrhosis in MASH represents a severe stage before decompensation, where mortality risk escalates significantly. The potential ability to reverse cirrhosis could have a substantial impact on the disease trajectory for high-risk patients.
Market Implications:
The positive data from the SYMMETRY study position EFX as a potential first-in-class therapy for MASH cirrhosis, addressing a critical unmet need in the market. The robust efficacy data, especially in cirrhosis reversal, could support premium pricing and favorable reimbursement decisions. Key market implications include a first-mover advantage in the cirrhotic MASH segment, differentiated positioning from existing treatments, a strong safety profile supporting chronic use, and multiple supportive biomarkers for treatment response monitoring.
Overall, the findings from Akero Therapeutics’ Phase 2b study on cirrhosis reversal with EFX present a promising outlook for patients with MASH-related cirrhosis and highlight the potential of EFX as a transformative treatment option.