Akero’s EFX Shows Significant Fibrosis Reversal In | Global Market News
(RTTNews) – Akero Therapeutics (AKRO) unveiled new information from its Phase 2b SYMMETRY trial highlighting the potential of efruxifermin – EFX to reverse fibrosis in sufferers with compensated cirrhosis (F4) on account of metabolic dysfunction-associated steatohepatitis or MASH.
The outcomes have been introduced on the EASL Congress 2025 in Amsterdam.
In the presentation, Akero emphasised that cirrhosis attributable to MASH has no efficient medical remedies moreover liver transplant, underscoring the high unmet need. EFX, in keeping with the company, is the primary remedy to reveal fibrosis reversal on this population, marking a breakthrough that units it other than present choices.
Lead investigator Dr. Mazen Noureddin acknowledged that with out a transplant, MASH cirrhosis sufferers face a 50% mortality fee within 5 years. He famous that EFX’s anti-fibrotic results noticed within the SYMMETRY trial may symbolize one of probably the most vital medical advances in treating liver illness.
At Week 96, fibrosis enchancment with out MASH worsening was noticed in 39% of sufferers handled with EFX 50mg, in comparison with 15% within the placebo group, amongst sufferers with baseline and follow-up biopsies. In the intent-to-treat population, which included non-responders, 29% of the EFX 50mg group confirmed enchancment, versus 11% on placebo. While the first endpoint at Week 36 confirmed numerical enhancements, it didn’t attain statistical significance.
The information confirmed that EFX’s therapy impact grew considerably over time, with the placebo-adjusted response fee doubling from 10% at Week 36 to 24% at Week 96. This sustained response was additionally confirmed by noninvasive fibrosis markers like ELF scores and liver stiffness by Fibroscan.
Notably, the fibrosis advantages of EFX prolonged throughout key subgroups, regardless of sufferers’ kind 2 diabetes standing or use of GLP-1 medication or statins. Safety and tolerability remained according to earlier trials, with largely gentle to average and transient gastrointestinal unwanted effects.
The SYMMETRY research is a randomized, double-blind, placebo-controlled trial involving 182 sufferers with biopsy-confirmed compensated cirrhosis on account of MASH. Patients obtained weekly doses of EFX 28mg or 50mg, or placebo, for 96 weeks. EFX is now being additional evaluated in three ongoing Phase 3 trials concentrating on all levels of MASH.
EFX, Akero’s lead candidate, is an FGF21 analog designed for once-weekly dosing. It has proven potential in enhancing liver histology, metabolic parameters, and cardiovascular risk markers, offering a complete strategy to treating the multifaceted illness of MASH.
Friday, AKRO closed at $39.85, down 5.99%, and is presently trading at $40.12 in after-hours, up 0.69%, on the NASDAQ Global Select Market.
The views and opinions expressed herein are the views and opinions of the creator and don’t essentially replicate these of Nasdaq, Inc.
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