Pegcetacoplan treatment shows increased effects over time in geographic atrophy

Pegcetacoplan, a targeted C3 therapy designed to regulate excessive activation os the complement cascade, is on track to become the first treatment for geographic atrophy (GA) with a PDFU date of Nov. 26 and EU MAA submission on track by end of year. Data of phase 3 DERBY and OAKS studies demonstrate a robust reduction of GA lesion growth compared to sham.

The stages of advanced dry AMD or Geographic Atrophy

Apellis Pharmaceuticals has announced top-line data at 24 months showing increased effects over time with intravitreal pegcetacoplan, in the Phase 3 DERBY and OAKS studies in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
In a pre-specified analysis of GA lesion growth over 24 months, both monthly and every-other-month (EOM) pegcetacoplan showed a clinically meaningful reduction in GA lesion growth from baseline compared to sham:

• DERBY: 19% monthly, p=0.0004; 16% EOM, p=0.0030

• OAKS: 22% monthly, p<0.0001; 18% EOM, p=0.0002

Between months 18-24, the pegcetacoplan treatment effect accelerated compared to previous six-month periods, with robust reductions of GA lesion growth versus sham (all p-values are nominal). The increased effects were driven by a greater slowing of lesion growth by pegcetacoplan and not by an increase in the lesion growth rate in the sham group.

• DERBY: 36% monthly, p<0.0001; 29% EOM, p=0.0002

• OAKS: 24% monthly, p=0.0080; 25% EOM, p=0.0007

Additionally, the reduction of GA lesion growth in patients with extrafoveal lesions (28% monthly; 28% EOM) was comparable to the reduction in patients with foveal lesions (34% monthly; 28% EOM) in the combined studies between months 18-24.