Apellis Presents New Phase 3 DERBY and OAKS Data of Intravitreal Pegcetacoplan for GA

Apellis Pharmaceuticals announced that five oral presentations and two on-demand papers are being highlighted at the American Society of Retina Specialists Annual Scientific Meeting taking place July 13 -16, 2022 in New York City.

New data include an analysis from the Phase 3 DERBY and OAKS studies, which showed the mean rate (slope) of GA lesion growth at 18 months with both monthly and every-other-month intravitreal pegcetacoplan, an investigational, targeted C3 therapy for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The results were consistent with previously reported 18-month data, with all P-values (nominal) below 0.05.

Apellis announced the submission of a new drug application (NDA) for pegcetacoplan for GA to the FDA last month. The FDA decision on NDA filing acceptance is expected in August 2022. Apellis also plans to submit a marketing authorization application to the European Medicines Agency in the second half of 2022.

Symposium presentation details:

Phase 3 DERBY and OAKS Studies

• Assessment of Geographic Atrophy Lesion Progression in the Phase 3 OAKS and DERBY Trials; Dry AMD 1 Symposium; July 14; 9:06 - 9:10 a.m. ET
   
• Safety of Intravitreal Pegcetacoplan for Geographic Atrophy (GA): Results from the OAKS and DERBY Trials; Dry AMD 1 Symposium; July 14; 9:16 - 9:20 a.m. ET
   
• Relationship Between Number of Intermediate-Large Drusen and Geographic Atrophy (GA) Lesion Growth Rate in the Sham Groups of the OAKS, DERBY, and FILLY Trials; Dry AMD 3 Symposium; July 16; 10:59 - 11:03 a.m. ET

GA Disease Burden

• Retrospective Cohort Analysis of Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration Followed Up for 3 Years; Dry AMD 2 Symposium; July 15; 9:30 - 9:36 a.m. ET
   
• Characterizing Real-World Functional Outcomes in Patients with Geographic Atrophy: An IRIS Registry Analysis; Dry AMD 2 Symposium; July 15; 9:36 - 9:42 a.m. ET

Papers on demand:

• MOSAIC: A Qualitative Study of the Clinical, Humanistic, and Financial Burden of Geographic Atrophy (GA) Among Patients and Caregivers
   
• Detailed Baseline Demographics and Disease Characteristics of Patients with Geographic Atrophy (GA) Enrolled in the Phase 3 OAKS and DERBY Clinical Trials

About DERBY and OAKS

DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients in DERBY and OAKS will continue to receive masked treatment for 24 months. Secondary functional endpoints will be evaluated after all patients have received treatment for 24 months.