No cases of inflammation observed after 12 months with Phase 3 formulation of pegcetacoplan in patients with advanced geographic atrophy (GA)Decrease in mean lesion growth in nine patients with bilateral GA consistent with Phase 2 FILLY studyPhase 3 DERBY and OAKS studies expected to fully enroll in the first half of 2020WALTHAM, Mass., April 28, 2020 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company pioneering targeted C3 therapies, today announced early data from the Phase 1b APL2-103 study of pegcetacoplan (APL-2) in patients with advanced geographic atrophy (GA) and low vision. The study, which enrolled 12 patients, was initiated to assess the safety of the Phase 3 formulation of pegcetacoplan (15mg/0.1mL). Patients were dosed with pegcetacoplan in one eye using the fellow eye as untreated control. The analysis of APL2-103 has shown that the Phase 3 formulation was well tolerated over 12 months of treatment. Of the 12 patients, there were no cases of inflammation and one patient (8%) developed new-onset exudation. The formulation used in this Phase 1b study is the same as that being evaluated in the Phase 3 DERBY and OAKS GA studies, which are expected to be fully enrolled in the first half of 2020.“Our Phase 1b analysis has provided robust safety data, along with a trend of decreased mean lesion growth, for pegcetacoplan in geographic atrophy patients who received treatment with the Phase 3 formulation over 12 months,” said Federico Grossi, M.D., Ph.D., Chief Medical Officer of Apellis. “We are encouraged by these results, which give us confidence in targeting C3 and advancing pegcetacoplan as a potential treatment for GA in our ongoing Phase 3 studies.”Additional analysis at 12 monthsView full graph by clicking on the image or link below:
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