Apellis announces mixed Phase 3 GA trial results; OAKS met primary endpoint, DERBY missed

Apellis Pharmaceuticals, Inc.

OAKS trial met primary endpoint: monthly pegcetacoplan reduced GA lesion growth by 22% (p=0.0003), every-other-month by 16% (p=0.0052) vs sham at 12 months.
DERBY trial missed primary endpoint: monthly reduced growth by 12% (p=0.0528), every-other-month by 11% (p=0.0750) vs sham.
Prespecified combined analysis: monthly reduced growth by 17% (p<0.0001), every-other-month by 14% (p=0.0012) vs sham at 12 months.
Greater effect in extrafoveal lesions: combined analysis showed 26% (monthly) and 23% (every-other-month) reduction vs sham (p<0.001).
Company plans to submit NDA to FDA in H1 2022 and MAA in Europe; well-tolerated with low rates of endophthalmitis and intraocular inflammation.

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