Apellis Announces New Analysis Demonstrating Targeted C3 Therapy Pegcetacoplan Slows Progression of Early Disease in Patients with Geographic Atrophy (GA)

• Post hoc analysis of Phase 2 FILLY study shows 39% reduction in rate of progression from nascent GA, an earlier form of disease, to GA in patients treated with pegcetacoplan monthly vs. sham
  
• First ever observation of slowed nascent GA progression in a Phase 2 study signals potential benefit of earlier intervention with pegcetacoplan in patients with GA
  
• Data support hypothesis that targeting C3 with pegcetacoplan addresses an underlying cause of disease, excessive complement activation, as evidenced by slowed progression of nascent GA to GA
  

WALTHAM, Mass., Oct. 03, 2020 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced the results of a post hoc analysis of the Phase 2 FILLY study investigating intravitreal pegcetacoplan (APL-2) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The post hoc analysis found that monthly treatment with pegcetacoplan significantly reduced the rate of progression from nascent GA to GA in areas of the retina outside of existing GA lesions. The data were presented today in a late-breaking oral session at the European Society of Retina Specialists 2020 Virtual (EURETINA).

Pegcetacoplan is the only targeted C3 therapy in Phase 3 clinical trials for GA, a complement-driven eye disease^1,2 that causes blindness, affects approximately five million people globally^3,4 and has no approved treatment.

• In the post hoc analysis, progression from nascent GA to GA was observed in 50.0% of the pegcetacoplan-treated group and 81.8% of the sham-treated group (p=0.02).
  
• The 39% reduction in progression from nascent GA to GA indicates that pegcetacoplan slows the rate of progression of AMD in areas of the retina outside of GA lesions.
  
• Progression from large drusen (deposits in the retina that are a hallmark of AMD) to nascent GA or GA at Month 12 was observed in 22.6% of patients in the pegcetacoplan-treated group and 33.3% of patients in the sham-treated group (p=0.31).
  

“Our findings from this post-hoc analysis demonstrate that intravitreal pegcetacoplan, a targeted C3 therapy, significantly lowers the rate of progression from nascent GA to GA in patients when compared to sham controls,” said SriniVas Sadda, M.D., President & Chief Scientific Officer of the Doheny Eye Institute and lead investigator. “This study provides exciting evidence to support further exploration of the potential of pegcetacoplan for earlier intervention in the course of GA.”