Akero's EFX Shows Significant Fibrosis Reversal In MASH Cirrhosis At 96 Weeks

(RTTNews) - Akero Therapeutics (AKRO) unveiled new data from its Phase 2b SYMMETRY trial highlighting the potential of efruxifermin - EFX to reverse fibrosis in patients with compensated cirrhosis (F4) due to metabolic dysfunction-associated steatohepatitis or MASH.

The results were presented at the EASL Congress 2025 in Amsterdam.

In the presentation, Akero emphasized that cirrhosis caused by MASH has no effective medical treatments besides liver transplant, underscoring the high unmet need. EFX, according to the company, is the first therapy to demonstrate fibrosis reversal in this population, marking a breakthrough that sets it apart from current options.

Lead investigator Dr. Mazen Noureddin stated that without a transplant, MASH cirrhosis patients face a 50% mortality rate within five years. He noted that EFX's anti-fibrotic effects observed in the SYMMETRY trial could represent one of the most significant medical advances in treating liver disease.

At Week 96, fibrosis improvement without MASH worsening was observed in 39% of patients treated with EFX 50mg, compared to 15% in the placebo group, among patients with baseline and follow-up biopsies. In the intent-to-treat population, which included non-responders, 29% of the EFX 50mg group showed improvement, versus 11% on placebo. While the primary endpoint at Week 36 showed numerical improvements, it did not reach statistical significance.

The data showed that EFX's treatment effect grew substantially over time, with the placebo-adjusted response rate doubling from 10% at Week 36 to 24% at Week 96. This sustained response was also confirmed by noninvasive fibrosis markers like ELF scores and liver stiffness by Fibroscan.

Notably, the fibrosis benefits of EFX extended across key subgroups, regardless of patients' type 2 diabetes status or use of GLP-1 drugs or statins. Safety and tolerability remained consistent with earlier trials, with mostly mild to moderate and transient gastrointestinal side effects.

The SYMMETRY study is a randomized, double-blind, placebo-controlled trial involving 182 patients with biopsy-confirmed compensated cirrhosis due to MASH. Patients received weekly doses of EFX 28mg or 50mg, or placebo, for 96 weeks. EFX is now being further evaluated in three ongoing Phase 3 trials targeting all stages of MASH.

EFX, Akero's lead candidate, is an FGF21 analog designed for once-weekly dosing. It has shown potential in improving liver histology, metabolic parameters, and cardiovascular risk markers, offering a comprehensive approach to treating the multifaceted disease of MASH.

Friday, AKRO closed at $39.85, down 5.99%, and is currently trading at $40.12 in after-hours, up 0.69%, on the NASDAQ Global Select Market.