Apellis Pharmaceuticals Inc, a global biopharmaceutical company pioneering targeted C3 therapies, today announced that it completed enrollment in the Phase 3 DERBY and OAKS studies investigating intravitreal pegcetacoplan (APL-2), a targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA causes blindness and is a progressive complement-driven eye disease1,2 that affects approximately five million people globally.3,4 There are no approved therapies for GA.
“Completing enrollment in the Phase 3 DERBY and OAKS studies is a critical milestone that moves us one step closer to bringing the first treatment for geographic atrophy to patients. We are extremely grateful to all patients participating in these groundbreaking studies,” said Federico Grossi, M.D., Ph.D., Chief Medical Officer of Apellis. “People living with GA need a treatment and we believe targeting the complement system at C3 with pegcetacoplan has the potential to control the excessive complement activation that drives the irreversible growth of GA lesions that cause blindness. We look forward to seeing top-line results in the third quarter of 2021.”
A total of 1,259 patients are enrolled in DERBY and OAKS, which are pivotal randomized Phase 3 studies designed to compare the efficacy and safety of intravitreal pegcetacoplan with sham treatment in patients with GA secondary to AMD. The primary objective of the studies is to evaluate the reduction in growth of GA lesion size, measured by fundus autofluorescence (FAF) at month 12 compared to baseline.
Read the full press release here.