Apellis' C3 inhibitor slows progression of dry AMD
Apellis Pharmaceuticals Inc. (Crestwood, Ky.) said its lead candidate APL-2 met the primary endpoint of reducing lesion growth compared to sham procedure in the Phase II FILLY trial to treat geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD) for which there are no approved treatments. Apellis CEO Cedric Francois told BioCentury the company plans to start Phase III testing of the complement 3 (C3) inhibitor to treat GA associated with AMD in 2H18.
In the single-blind, 246-patient trial, once-monthly intravitreal injections of APL-2 reduced GA lesion growth from baseline to 12 months by 29% compared to sham control (p=0.008). APL-2 given every other month reduced the endpoint by 20% vs. sham control (p=0.067). The company said the pre-specified threshold for significance was a p-value of ≤0.1...