- Apellis Pharmaceuticals Inc APLS announced topline data at 24 months showing increased effects over time with intravitreal pegcetacoplan in geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- In a pre-specified analysis, monthly and every-other-month pegcetacoplan showed a clinically meaningful reduction in GA lesion growth from baseline compared to sham.
- Between months 18-24, the pegcetacoplan treatment effect accelerated compared to previous six-month periods, with robust reductions of GA lesion growth versus sham.
- Related: HC Wainwright Initiates Coverage On Upcoming Complement Franchise Company Apellis Pharmaceuticals.
- A greater slowing of lesion growth drove the increased effects by pegcetacoplan and not by an increase in the lesion growth rate in the sham group, which was highly consistent over each of the four six-month intervals.
- No clinically meaningful difference between pegcetacoplan and sham was observed in the key secondary endpoints measuring visual function at 24 months.
- Pegcetacoplan demonstrated a favorable safety profile, consistent with safety data to date and longer-term exposure to intravitreal injections.
- The results at 24 months will be included in the marketing application that the company plans to submit to the European Medicines Agency by the end of this year. The U.S. marketing application is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 26.
- Price Action: APLS shares are down 4.63% at $63.62 on the last check Wednesday.
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