Pharma Focus America

Akero Therapeutics Announces Positive End-of-Phase 2 Meeting with the FDA and SYNCHRONY Phase 3 Program for Efruxifermin in NASH

Thursday, March 30, 2023

Akero Therapeutics, Inc., a clinical-stage company developing transformational treatments for patients with serious metabolic disease and high unmet medical need, today announced a positive End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) as well as details of the anticipated SYNCHRONY Phase 3 efruxifermin program for the treatment of nonalcoholic steatohepatitis (NASH). There are currently no approved therapies for the treatment of NASH, a serious form of liver disease estimated to affect more than 17 million Americans.

“We are appreciative of the FDA’s support and guidance and are pleased to have aligned on key features of our SYNCHRONY Phase 3 program, with further dialogue envisaged following readout of the Phase 2b SYMMETRY trial evaluating EFX in patients with cirrhosis due to NASH,” said Kitty Yale, chief development officer of Akero. “The strength of EFX’s clinical profile reported to date in our Phase 2 studies gives us confidence in EFX’s potential to be a best-in-class FGF21 analog for treating NASH, if approved, and we look forward to enrolling patients into our first two Phase 3 trials within the SYNCHRONY program later this year.”

Based on ongoing discussions with the FDA, the SYNCHRONY Phase 3 program will start enrolling patients into two parallel, randomized, placebo-controlled clinical trials during the second half of this year.

  • SYNCHRONY Histology will evaluate the efficacy of 28mg and 50mg doses of EFX in patients with biopsy confirmed pre-cirrhotic NASH, with fibrosis stage 2 or 3 (F2-F3). The primary endpoint will be ≥ 1-stage fibrosis improvement AND resolution of NASH.
  • SYNCHRONY Real-World will assess safety and tolerability of EFX in patients with non-invasively diagnosed NASH or NAFLD. Key secondary endpoints are to include change in biomarkers of fibrosis and other established non-invasive endpoints.
  • The duration of and total number of subjects to be enrolled in the SYNCHRONY Histology and Real-World trials are subject to confirmation with the FDA.

Following readout of the Phase 2b SYMMETRY trial during the fourth quarter of this year, and subsequent interactions with the FDA, Akero expects to finalize the design of the third Phase 3 clinical trial within the SYNCHRONY program.

  • SYNCHRONY Outcomes is planned to evaluate the efficacy and safety of EFX in a compensated cirrhotic population, for which the primary endpoint will be clinical outcomes.

As previously indicated and consistent with ICH guidelines, the overall SYNCHRONY program has been designed to comprise a minimum of 1,500 patients exposed to the dose(s) of EFX that are anticipated to be proposed for approval.

 

Source: globenewswire.com

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