The Phase 3 SYNCHRONY clinical trial program consists of three trials, two of which have started enrolling patients and the third to be initiated in Q2’24. The first two trials under way are parallel, randomized, placebo-controlled trials: SYNCHRONY Histology evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), and SYNCHRONY Real-World assessing safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease (MASLD). SYNCHRONY Histology is expected to enroll approximately 1,000 patients with biopsy-confirmed MASH, fibrosis stage 2 or 3 (F2-F3) 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 ≥ 1-stage fibrosis improvement AND resolution of 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 MASH or 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. Read more at Clinicaltrials.gov: SYNCHRONY Histology and SYNCHRONY Real-World.