Apellis Announces Pegcetacoplan Showed Continuous and Clinically Meaningful Effects at Month 18 in Phase 3 DERBY and OAKS Studies for Geographic Atrophy (GA)

• Both monthly and every-other-month pegcetacoplan continued to reduce GA lesion growth compared to pooled sham at 18 months with all p-values (nominal) below 0.05
  • Treatment effects in DERBY were comparable to OAKS during months 6-18
  • Pegcetacoplan continued to demonstrate a favorable safety profile 
• Combined 18-month data show the potential for improving treatment effects over time
• Data to be included in the NDA submission planned for Q2
• Conference call today at 8:30 a.m. ET

WALTHAM, Mass., March 16, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced longer-term data from the Phase 3 DERBY and OAKS studies, which showed that intravitreal pegcetacoplan, an investigational, targeted C3 therapy, continued to reduce geographic atrophy (GA) lesion growth and demonstrate a favorable safety profile at month 18 for the treatment of GA secondary to age-related macular degeneration (AMD). These data will be included in the New Drug Application (NDA) that the company plans to submit to the U.S. Food and Drug Administration (FDA) in the second quarter of 2022.

“It is exciting to see these positive data with pegcetacoplan, which showed continuous and potentially improving effects over time. These 18-month results provide further evidence that pegcetacoplan meaningfully slows disease progression and has the potential to preserve vision longer,” said Jeffrey S. Heier, M.D., principal investigator of the DERBY study and director, retina service and director, retinal research, Ophthalmic Consultants of Boston. “In my practice, I have seen how devastating it can be for people living with GA to lose more of their vision year after year. There is an urgent unmet need in GA, and these results reinforce the potential of pegcetacoplan to become the first-ever treatment for patients with this debilitating disease.”

Monthly and Every-Other-Month Pegcetacoplan Showed Continuous Effects Over Time

A Media Snippet accompanying this announcement is available by clicking on the image or link below:

In a longer-term analysis of the primary endpoint, pegcetacoplan continued to reduce GA lesion growth compared to pooled sham at month 18 (all p-values are nominal):

• In OAKS, pegcetacoplan reduced GA lesion growth with both monthly (22%; p