Apellis Pharma Flunks On Primary, Secondary Endpoints In Amyotrophic Lateral Sclerosis Study

Apellis Pharmaceuticals Inc APLS announced that the Phase 2 MERIDIAN study investigating systemic pegcetacoplan for amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of the Combined Assessment of Function and Survival (CAFS) rank score at Week 52.
CAFS ranks patients' clinical outcomes based on survival time and change in the ALS Functional Rating Scale-Revised (ALSFRS-R) score.
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 Swedish Orphan Biovitrum AB BIOVF plan to discontinue the 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.
In April, a Bloomberg report noted that large drugmakers were interested in Apellis Pharmaceuticals.
The report added that Apellis might seek partnerships or licensing agreements for some of its ophthalmology products. Deliberations are ongoing, and there's no certainty they will lead to a transaction.
Price Action: APLS shares are down 2.05% at $84.79 on the last check Thursday.