Apellis Reports Top-Line Results from Phase 2 MERIDIAN Study in ALS

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[{"type":"text","content":"WALTHAM, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced that the Phase 2 MERIDIAN study investigating systemic pegcetacoplan for the treatment of amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival (CAFS) rank score at Week 52. The study also did not meet key secondary efficacy endpoints. Systemic pegcetacoplan was well tolerated in the study, and the data were consistent with the established safety profile. Based on the lack of efficacy, Apellis and Sobi plan to discontinue development of systemic pegcetacoplan for ALS. In April, Apellis and Sobi discontinued treatment in the open-label portion of the study, following a recommendation from an independent data monitoring committee. “We are disappointed in the outcome of the MERIDIAN study, especially on behalf of the ALS community who has been waiting for new treatments for this complex and unrelenting disease. We would like to sincerely thank the study participants and their caregivers from around the world who contributed to this important research,” said Jeffrey Eisele, Ph.D., chief development officer, Apellis. “Our hope is that the data generated from this study will continue to support future research and development in ALS.” The full MERIDIAN dataset is being analyzed, and detailed data is expected to be presented at a future medical meeting. About the Phase 2 MERIDIAN StudyThe Phase 2 MERIDIAN study (NCT04579666) is a randomized, double-blind, placebo-controlled, multicenter study designed to evaluate the efficacy and safety of systemic pegcetacoplan in approximately 250 adults with sporadic amyotrophic lateral sclerosis (ALS). Study participants were randomized in a 2:1 ratio to receive pegcetacoplan or placebo while continuing to receive their existing standard of care treatment for ALS for 52 weeks. The primary endpoint of the study is the Combined Assessment of Function and Survival (CAFS) rank scores. Key secondary endpoints include measures of overall function, survival, lung function, and muscle strength. After 52 weeks, all study participants were to receive pegcetacoplan. To reduce the burden on people living with ALS and their caregivers, the study has been designed to minimize the number of in-clinic visits. About Amyotrophic Lateral Scle...

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