- Monthly and every-other-month treatment with pegcetacoplan showed a continuous and clinically meaningful reduction in the growth of both extrafoveal and foveal lesions at month 18 (all p-values nominal)
- Continued to demonstrate a robust effect in patients with extrafoveal lesions
- Showed an improved effect in patients with foveal lesions
- Ten presentations, including three oral presentations, showcase Apellis’s leadership in retina
Monthly and every-other-month pegcetacoplan showed a continuous and clinically meaningful reduction in the growth of both extrafoveal and foveal lesions at month 18. The analysis was reported during an oral presentation at the
“Slowing disease progression and preserving vision longer is critical for all patients with GA, so I am very encouraged that pegcetacoplan continuously reduced lesion growth over time in patients who are representative of the real-world GA population,” said
Pegcetacoplan Continues to Reduce GA Lesion Growth in Broad Patient Population at Month 18
In a longer-term analysis of the primary endpoint, pegcetacoplan continued to show a robust reduction in GA lesion growth in patients with extrafoveal lesions and an improved effect in patients with foveal lesions compared to pooled sham at month 18 (all p-values are nominal). GA typically presents first with extrafoveal lesions, which then progress toward the fovea where central vision is impacted.
- Pegcetacoplan reduced extrafoveal GA lesion growth in OAKS by 33% (p<0.0001) and 17% (p=0.0422) with both monthly and every-other-month treatment, respectively, and in DERBY by 17% (p=0.0606) and 23% (p=0.0075), respectively.
- Pegcetacoplan reduced foveal GA lesion growth in OAKS by 18% (p=0.0105) and 19% (p=0.0020) with both monthly and every-other-month treatment, respectively, and in DERBY by 9% (p=0.2015) and 4% (p=0.5538), respectively.
- In the combined studies, pegcetacoplan reduced extrafoveal GA lesion growth by 26% (p<0.0001) and 21% (p=0.0006) with both monthly and every-other-month treatment, respectively, and reduced foveal lesion growth by 13% (p=0.0070) and 13% (p=0.0069), respectively.
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“We are excited to see that longer-term use of monthly and every-other-month pegcetacoplan reinforces the potential for our targeted C3 therapy to slow GA progression regardless of disease severity,” said
At month 18, pegcetacoplan continued to demonstrate a favorable safety profile, consistent with safety rates at 12 months and longer-term exposure to intravitreal injections. The combined rate of new-onset exudations at month 18 was 9.5%, 6.2%, and 2.9% in the pegcetacoplan monthly, every-other-month, and sham groups, respectively. Rates of infectious endophthalmitis and intraocular inflammation continue to be consistent with those reported in studies of other intravitreal therapies.1,2,3
These data will be included in the New Drug Application that the company plans to submit to the
Ten Presentations Showcase Apellis’s Leadership in Retina
Two oral presentations included an 18-month analysis from the Phase 3 DERBY and OAKS studies that adjusted for imbalances in baseline characteristics known to be associated with lesion growth as well as results from a consensus survey on GA management.
Seven scientific presentations highlighted data from the pegcetacoplan clinical development program for GA, the disease burden, and use of artificial intelligence to identify, monitor, and predict GA lesion growth. Four of the artificial intelligence presentations were in collaboration with the Ophthalmic Image Analysis (OPTIMA) group at the
About DERBY and OAKS
DERBY (621 patients enrolled) and OAKS (637 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies comparing the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with geographic atrophy (GA) secondary to age-related macular degeneration (
The nominal p-values presented in the month 18 results were calculated using the same methodology as the month 12 primary endpoint analysis.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (
About Pegcetacoplan for Geographic Atrophy (GA)
Pegcetacoplan is an investigational, targeted C3 therapy designed to regulate excessive activation of the complement cascade, part of the body’s immune system, which can lead to the onset and progression of many serious diseases. Pegcetacoplan was granted Fast Track designation by the
About Apellis
Apellis Forward-Looking Statement
Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding timing of anticipated regulatory submissions. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including whether the results of the FILLY, DERBY and OAKS trials are sufficient to support regulatory submissions; whether a submission for approval of intravitreal pegcetacoplan for GA on the basis of the FILLY, DERBY and OAKS trials will be accepted by the FDA or foreign regulatory agencies; whether intravitreal pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA when expected or at all; and other factors discussed in the “Risk Factors” section of Apellis’ Annual Report on Form 10-K with the
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1Morioka et al. Incidence of endophthalmitis after intravitreal injection of an anti-VEGF agent with or without topical antibiotics. Scientific Reports 2020.
2Kiss et al. Endophthalmitis rates among patients receiving intravitreal anti-VEGF injections: a
3Cox et al. Inflammatory complications of intravitreal anti-VEGF injections.
4 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: a meta analysis. Ophthalmology 2012;119:571–580.
5Wong WL, Su X, Li X, et al. Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106–116.
6 Lindblad AS, et al, and
7 Seddon, JM, Rosner, B. Validated prediction models for macular degeneration progression and predictors of visual acuity loss identify high-risk individuals. Am J Ophthalmol 2019;198:223–261.
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