Apellis gets a long-term boost

Apellis’s chances of getting intravitreal pegcetacoplan approved in geographic atrophy now look a little brighter. The group today reported a benefit at 18 months in the pivotal Derby and Oaks trials – previously only Oaks hit its primary endpoint, reduction in GA lesion growth at 12 months. True, given the earlier Derby failure, the latest findings are only exploratory. However, some analysts have long maintained that pegcetacoplan, a complement inhibitor, is approvable and the latest results will only strengthen this view. Apellis’s stock climbed 10% this morning, but it is still way off last year’s highs. Naysayers might point to the incidence of choroidal neovascularisations, which at 18 months increased to 9% and 6% of patients on the monthly and every-other-month dose respectively. But during a conference call today Derby’s lead investigator, Dr Jeffrey Heier of Ophthalmic Consultants of Boston, noted that these are treatable with anti-VEGFs, while there is no approved therapy for geographic atrophy. This could factor into the FDA’s decision; Apellis is planning a filing in the second quarter. Next up in geographic atrophy is readout of Iveric’s phase 3 Gather2 trial of its complement inhibitor Zimura, due in the second half.

Phase 3 data on Apellis's pegcetacoplan
  Reduction in GA lesion growth at 18 months vs pooled sham
Study Pegcetacoplan monthly Nominal p value Pegcetacoplan every other month Nominal p value
Oaks (637 pts) 22% <0.0001 16% 0.0018
Derby (621 pts) 13% 0.0254 12% 0.0332
  Reduction in GA lesion growth at 1yr vs pooled sham
  Pegcetacoplan monthly P value Pegcetacoplan every other month P value
Oaks (637 pts) 22% 0.0003 16% 0.0052
Derby (621 pts) 12% 0.0528 11% 0.0750
Source: Company releases.

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