- Apellis Pharmaceuticals Inc APLS announced that the Phase 2 MERIDIAN study evaluating systemic Pegcetacoplan in amyotrophic lateral sclerosis (ALS) did not meet its primary endpoint of Combined Assessment of Function and Survival (CAFS). Rank score in week 52.
- CAFS assesses patients’ clinical outcomes based on survival time and change in ALS Functional Rating Scale-Revised (ALSFRS-R) score.
- The study also failed to meet key secondary efficacy endpoints. Systemic Pegcetacoplan was well tolerated in the study and the data were consistent with the established safety profile.
- Due to the lack of effectiveness, Apellis and Swedish Orphan Biovitrum AB BIOVF plan to discontinue development of systemic Pegcetacoplan for ALS.
- In April, Apellis and Sobi discontinued treatment in the open-label portion of the study on the recommendation of an independent data monitoring committee.
- In April, a Bloomberg report found that major drugmakers were interested in Apellis Pharmaceuticals.
- The report added that Apellis may be seeking partnerships or licensing deals for some of its eye care products. Consultations are ongoing and there is no certainty about this will result in a transaction.
- Price promotion: APLS shares are down 2.05% at $84.79 at last check on Thursday.
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