AKRO - Akero plans to begin Phase 3 trial of NASH treatment in H2 after successful FDA meet

2023-03-29 16:38:00 ET

• Akero Therapeutics said it had a positive end-of-Phase 2 meeting with the U.S. Food and Drug Administration and also discussed details of the upcoming Phase 3 trial of efruxifermin to treat nonalcoholic steatohepatitis ( NASH ).
• The company will start enrolling patients for the late-stage trial during the second half of the year.
• “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 (efruxifermin) in patients with cirrhosis due to NASH,” said Kitty Yale, chief development officer of Akero.
• The planned Phase 3 study consists of three trials - SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes - to evaluate the safety and efficacy of efruxifermin.
• The company will evaluate 28mg and 50mg of EFX in the phase 3 trials.
• There are currently no approved therapies for the treatment of NASH.
• Press Release

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