Update on Open-Label Portion of the MERIDIAN Study Investigating Systemic Pegcetacoplan for Amyotrophic Lateral Sclerosis (ALS)
Apellis and Sobi made the decision to discontinue investigational treatment with systemic pegcetacoplan in the open-label period of the MERIDIAN study for amyotrophic lateral sclerosis (ALS). Our decision was made following an unblinded review from an independent data monitoring committee of the available data, which did not support continuation of treatment. Their recommendation was not based on any safety concerns.
Prior to the decision, all patients completed the randomized treatment period, and the data will be analyzed as planned, with top-line results in mid-2023. A decision on next steps for the program will be made following the planned analysis of the full data.
We want to thank all the people living with ALS and their caregivers who participated in the study and appreciate the partnerships built with the broader ALS community. We are committed to continuing our work together as we analyze the data generated from this study.