Phase 3 trial of Apellis' geographic atrophy treatment to begin this year
Apellis Pharmaceuticals finalized plans for a phase 3 clinical trial program for APL-2, its treatment for geographic atrophy associated with age-related macular degeneration, the company announced in a press release.
The program, set to begin in the second half of this year, will include two identical 600-patient prospective, multicenter, randomized, double-masked, sham-injection controlled studies evaluating the efficacy and safety of multiple intravitreal injections of the treatment, the release said.
APL-2 is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds to C3 and C3b, blocking the pathways of complement activation, the release said.
“Currently there are no approved treatments for the approximately 1 million patients suffering from GA in the U.S.,” Cedric Francois, MD, PhD, Apellis founder and CEO, said in the release. “We believe that by slowing down the rate of degeneration of retinal tissue through broad C3 inhibition, we may be able to delay or prevent the progression to blindness in these patients.”
The ongoing phase 2 FILLY trial showed a 29% reduction in the growth of geographic atrophy lesions after 12 months in the monthly treatment group, which was a statistically significant difference, and a 20% reduction in the every-other-month treatment group, which was not statistically significant.