
- Apellis Pharmaceuticals Inc (NASDAQ:APLS) announced longer-term data from the Phase 3 DERBY and OAKS studies, which showed that intravitreal pegcetacoplan continued to reduce geographic atrophy (GA) lesion growth.
- These data will be included in the U.S. marketing application that the Company plans to submit in Q2 of 2022.
- In the OAKS study, pegcetacoplan reduced GA lesion growth with both monthly (22%) and every other month treatment (16%), and in the DERBY study, the percentages stood at 13% and 12%, respectively.
- Also See: Apellis - Sobi's Pegcetacoplan Wins European Approval For Rare Blood Disorder.
- Pegcetacoplan demonstrated marked improvements in DERBY during months 6-12 with reductions of 17% with monthly and 16% with every-other-month treatment compared to months 0-6, and the treatment effects were sustained through month 18.
- The treatment effects observed in DERBY were comparable with OAKS during months 6-18.
- Data at 18 months from the combined studies show the potential for improving treatment effects with pegcetacoplan over time.
- The rate of infectious endophthalmitis was 0.044% per injection, and the rate of intraocular inflammation was 0.23% per injection.
- Price Action: APLS shares are up 15.20% at $46.13 during the market session on the last check Wednesday.