Apellis Pharmaceuticals has announced that it has finalized the trial design for its planned Phase 3 program evaluating APL-2 for the treatment of patients with geographic atrophy (GA), aka dry macular degeneration.
The Phase 3 program, planned to begin in the second half of 2018, will consist of two identical studies to assess the efficacy and safety of multiple injections of APL-2 in the eyes of patients with GA. The Phase 3 trials will be substantially similar in design to Apellis’ ongoing Phase 2 FILLY trial, which, at 12 months, showed a 29% reduction in the growth of GA lesions (damaged areas of the retina) in the monthly treatment group and a 20% reduction in the every other month treatment group.
“Our Phase 3 trial design is intended to address a patient population similar to the one we studied in Phase 2, which we believe is representative of the general population of patients with GA in the United States,” said Cedric Francois, MD, PhD, founder and chief executive officer of Apellis. “Currently there are no approved treatments for the approximately one million patients suffering from GA in the US. 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.”
For current information about all major research for treatment of geographic atrophy, see “A Guide to Research in Dry AMD” on this site.