Apellis Announces 24-Month Results Showing Increased Effects Over Time with Pegcetacoplan in Phase 3 DERBY and OAKS Studies in Geographic Atrophy (GA)

Pegcetacoplan treatment effect accelerated between months 18-24, demonstrating a robust reduction of GA lesion growth compared to sham (all p-values are nominal)

• DERBY: 36% monthly, p<0.0001; 29% every-other-month (EOM), p=0.0002
• OAKS: 24% monthly, p=0.0080; 25% EOM, p=0.0007
  

Consistent with expectations, no clinically meaningful difference on key functional endpoints observed at 24 months

Continued to demonstrate a favorable safety profile

Potential to become the first-ever treatment for GA with a U.S. PDUFA date of Nov. 26, 2022; EU marketing authorization application submission on track by end of year

Conference call today at 8:30 a.m. ET

Excerpt from the Press Release:

WALTHAM, Mass., Aug. 24, 2022 (GLOBE NEWSWIRE) — Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced top-line data at 24 months showing increased effects over time with intravitreal pegcetacoplan, an investigational, targeted C3 therapy, in the Phase 3 DERBY and OAKS studies in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

“I am thrilled to see the increased effects over time, which suggest that pegcetacoplan is preserving more and more photoreceptor cells that are directly responsible for vision,” said Eleonora Lad, M.D., Ph.D., lead principal investigator for the OAKS study, associate professor of ophthalmology, director of ophthalmology clinical research unit, Duke University Medical Center. “The vision loss caused by GA is devastating for patients, taking away their ability to perform critical daily tasks like driving, reading, and recognizing faces. It is very exciting to finally be on the brink of the first potential GA treatment with pegcetacoplan.”

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