AKRO - Akero to evaluate lead asset in an adaptive Phase 2b/3 NASH trial

Akero Therapeutics (AKRO) has received written guidance from the FDA that enables the company to implement a combined Phase 2b/3 study for its lead candidate efruxifermin ((EFX)) in NASH patients.Under the planned adaptive trial design, Akero will evaluate two EFX doses in a 24-week Phase 2b portion of the trial for the selection of a single dose for the Phase 3 portion of the study. The company remains on track to initiate the trial in biopsy-confirmed NASH patients in the first half of 2021.In June, the company announced additional positive data from the BALANCED study for EFX in NASH patients.

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Akero to evaluate lead asset in an adaptive Phase 2b/3 NASH trial