Apellis reports top-line results from phase II MERIDIAN study of pegcetacoplan in ALS.
Apellis Pharmaceuticals, Inc. announced that the Phase II 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.”
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