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.
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.
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.