Apellis' C3 inhibitor slows progression of dry AMD in Phase II

Apellis Pharmaceuticals Inc. (Crestwood, Ky.) reported data from the single-blind, international Phase II FILLY trial in 246 patients with geographic atrophy (GA), an advanced form of dry age-related macular degeneration (AMD), showing that APL-2 met the primary endpoint of reducing lesion growth compared to sham procedure. Specifically, once-monthly intravitreal injections of APL-2 reduced GA lesion growth from baseline to 12 months by 29% vs. 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.

A post hoc analysis of the trial’s second 6-month period showed that the two APL-2 regimens reduced GA lesion growth by 47% (p<0.001) and 33% (p=0.01) vs. sham control, respectively...