A two-trial phase 3 clinical program for APL-2 for geographic atrophy has begun with the first patient enrolled in the DERBY trial and the first patient dosed in the OAKS trial, Apellis Pharmaceuticals announced in a press release.
The two-trial prospective, international, multicenter, randomized, double-masked, sham-injection controlled program will include 600 patients with geographic atrophy and assess the efficacy and safety of multiple intravitreal injections of APL-2, the release said.
“Dosing the first patient in our phase 3 program in geographic atrophy is an exciting milestone for Apellis, physicians and most importantly patients suffering from GA,” Cedric Francois, MD, PhD, co-founder and CEO of Apellis, said in the release. “APL-2 offers hope for patients currently without an approved treatment option.”
APL-2, which received fast track designation from the FDA, previously met its primary endpoint of a reduction in geographic atrophy lesion growth after 12 months in the phase 2 FILLY trial.