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Apellis Provides 24-Month Update from Phase 1b Study of Pegcetacoplan in Patients with Geographic Atrophy
Post hoc analysis showed a 46% decrease in mean lesion growth in eight patients with bilateral GA comparing treated eye vs. untreated fellow eye at 24 months
About this update from Apellis Pharmaceuticals, Inc.
[{"type":"text","content":"Post hoc analysis showed a 46% decrease in mean lesion growth in eight patients with bilateral GA comparing treated eye vs. untreated fellow eye at 24 months (p=0.007)Top-line data from Phase 3 DERBY and OAKS studies expected in Q3 2021 WALTHAM, Mass., April 13, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced 24-month data from the Phase 1b APL2-103 study of pegcetacoplan, an investigational targeted C3 therapy, in patients with advanced geographic atrophy (GA) secondary to age-related macular degeneration (AMD) and low vision. GA is a leading cause of blindness that affects approximately five million people worldwide1,2 and has no treatment. The Phase 1b study, designed to enroll approximately 12 patients with bilateral GA (disease in both eyes), was initiated to assess the safety of the Phase 3 formulation of pegcetacoplan (15mg/0.1mL). Patients were dosed monthly with pegcetacoplan in one eye using the fellow eye as an untreated control. The current post hoc analysis includes eight patients for whom data were available for at least 24 months. In this population, the growth rate of GA lesions in the treated eye was 46% (mean square root) slower than the untreated fellow eye (p=0.007). It has been shown that lesions in both eyes tend to grow at the same rate in patients with bilateral GA.3 Of the 13 enrolled patients, there were no reported cases of inflammation and two patients (16%) developed new-onset exudation during the 24-month study duration. “I am encouraged to see the continued effect of intravitreal pegcetacoplan in patients with GA.” stated Eleonora Lad, M.D., Ph.D., Associate Professor of Ophthalmology at the Duke University Medical Center. “I believe that these findings, which demonstrate a 46% reduction in GA lesion growth at 24 months, are clinically meaningful. I am excited to learn the Phase 3 DERBY and OAKS results later this year.” Post hoc analysis of Study APL2-103 at 24 months A Media Snippet accompanying this announcement is available by clicking on the image or link below: The patient population enrolled in the Phase 1b study is similar to patients enrolled in the Phase 3 DERBY and OAKS studies but allowed for more advanced disease with a wider range of baseline lesion size and lower baseline vi...