Apellis reports mixed results for geographic atrophy drug
Despite the mixed phase 3 results, the company says it plans to submit NDA to FDA in 2022
Apellis reported the top-line results from the Phase 3 DERBY and OAKS studies evaluating intravitreal pegcetacoplan in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
Overall, 1258 adults with GA were included in the studies. In OAKS, pegcetacoplan, significantly reduced GA lesion growth by 22% when taken monthly and by 16% when taken every-other-month compared to pooled sham at 12 months, meeting the primary endpoint.
In DERBY, the primary endpoint was not met. Monthly and every-other-month treatment pegcetacoplan reduced GA lesion growth in 12% and 11%, compared to pooled sham at 12 months.
In a prespecified analysis of the combined studies, monthly treatment with pegcetacoplan reduced GA lesion growth by 17% and every-other-month treatment with pegcetacoplan reduced GA lesion growth by 17% (p<0.0001) compared to pooled sham at 12 months.
The company plans to submit a New Drug Application for pegcetacoplan for GA to the FDA in the first half of 2022.
Read the full press release here.