Akero Therapeutics doses first patients in efruxifermin Phase 3 SYNCHRONY trial

Akero Therapeutics reported patients have received their first doses of efruxifermin in the SYNCHRONY Phase 3 program. Two parallel, randomized, placebo-controlled trials have commenced: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic nonalcoholic steatohepatitis/metabolic dysfunction-associated steatohepatiti, and SYNCHRONY Real-World assessing safety and tolerability of EFX in patients with non-invasively diagnosed NASH/MASH or non-alcoholic fatty liver disease/metabolic dysfunction-associated steatotic liver disease. SYNCHRONY Histology is expected to enroll approximately 1,000 patients with biopsy-confirmed NASH/MASH, fibrosis stage 2 or 3 to receive weekly injections of EFX 28mg, EFX 50mg, or placebo. The primary endpoint, to support an application for accelerated approval, is the proportion of patients experiencing greater than or equal to 1-stage fibrosis improvement AND resolution of NASH/MASH after 52 weeks of treatment. After 52 weeks, patients will continue treatment as randomized in SYNCHRONY Histology to be followed for long-term clinical outcomes, such as progression to cirrhosis. SYNCHRONY Real-World is expected to enroll approximately 600 patients with NASH/MASH or NAFLD/MASLD diagnosed by non-invasive tests to receive weekly injections of EFX 50mg or placebo. The primary endpoint of safety and tolerability will be assessed after 52 weeks of treatment. Key secondary endpoints in both the Histology and Real-World studies include changes from baseline in markers of liver injury and fibrosis, glycemic control and lipids. In all EFX Phase 3 studies, patients will self-administer EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use in the event EFX is approved for marketing. This optimized formulation delivers blood levels of EFX comparable to those of the liquid formulation used in prior clinical studies. An FDA Type B, End-of-Phase-2 meeting has been scheduled for the first quarter of 2024 to review the design of the planned SYNCHRONY Outcomes study evaluating EFX in the treatment of NASH/MASH patients with compensated cirrhosis (F4). SYNCHRONY Outcomes, as proposed to FDA, will evaluate regression of fibrosis based on histology, with the potential to support applications for accelerated and conditional approval in the United States and Europe, respectively, and follow patients with cirrhosis for long-term clinical outcomes to support full approval.