Apellis Announces Four Oral Presentations of Data from the Phase 3 DERBY and OAKS Studies of Pegcetacoplan in Geographic Atrophy (GA) to be Presented at the American Academy of Ophthalmology Annual Meeting
Apellis Pharmaceuticals (APLS) announced four oral presentations at the AAO Annual Meeting regarding pegcetacoplan for treating geographic atrophy (GA) due to age-related macular degeneration. The presentations will cover 24-month safety and efficacy results from Phase 3 DERBY and OAKS studies. The FDA has granted Priority Review for pegcetacoplan, with a target action date of November 26, 2022. The company plans to submit a marketing authorization application to the European Medicines Agency by year-end.
- Four oral presentations scheduled at the AAO Annual Meeting highlight pegcetacoplan's potential for GA treatment.
- Data from Phase 3 DERBY and OAKS studies demonstrate significant safety and efficacy results over 24 months.
- Pegcetacoplan has received FDA Fast Track designation, expediting its review process.
- No approved treatments exist for Geographic Atrophy, indicating high competition and risk.
- Regulatory approval for pegcetacoplan is uncertain and dependent on trial results.
WALTHAM, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in complement, today announced that four oral presentations of data from the Phase 3 DERBY and OAKS studies evaluating pegcetacoplan for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration will be presented at the American Academy of Ophthalmology (AAO) Annual Meeting on September 30 – October 3 in Chicago, Illinois. Data highlights include detailed 24-month results of safety and efficacy as well as exploratory analyses of lesion growth data and photoreceptor changes utilizing artificial intelligence guided image processing.
“Our scientific presence at AAO this year is a testament to our leadership in retina and the potential of pegcetacoplan to become the first treatment for GA, a devastating disease that leads to irreversible vision loss,” said Federico Grossi, M.D., Ph.D., chief medical officer, Apellis. “We look forward to sharing these data with the ophthalmology community as we work toward bringing pegcetacoplan to patients with GA as quickly as possible.”
The U.S. marketing application for pegcetacoplan for GA is under Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 26, 2022. Apellis plans to submit a marketing authorization application to the European Medicines Agency by the end of this year.
Presentation details:
- Treatment of Geographic Atrophy Secondary to AMD With Pegcetacoplan: Two-Year Outcomes from the Randomized Phase 3 DERBY and OAKS Trials – RET10 – Friday, Sept. 30 – 4:30 – 4:36 p.m. CST
- The Role of AI-Guided OCT Imaging in Geographic Atrophy – RET19 – Saturday, Oct. 1 – 3:13 – 3:19 p.m. CST
- Efficacy of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA024 – Sunday, Oct. 2, 8:12 – 8:19 a.m. CST
- Safety of Intravitreal Pegcetacoplan in GA: 24-Month Results from the Phase 3 DERBY and OAKS Trials – PA069 – Sunday, Oct. 2, 4:45 – 4:52 p.m. CST
e-Poster:
- Evaluation of Patients with GA Secondary to AMD: Analysis of the Academy IRIS® Registry – PO427
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 (AMD). The primary objective of the studies is to evaluate the efficacy of pegcetacoplan in patients with GA assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (p-value less than .05) at 12 months. Patients in DERBY and OAKS received masked treatment for 24 months. All patients who completed the DERBY or OAKS studies were invited to participate in the GALE open-label extension study.
About Geographic Atrophy (GA)
Geographic atrophy (GA) is an advanced form of age-related macular degeneration (AMD) and a leading cause of blindness that impacts more than 5 million people worldwide, including one million people in the United States.1,2 This progressive disease can severely impair visual function, independence, and quality of life as it takes on average 2.5 years for GA lesions to encroach the fovea, which is responsible for central vision.3 GA is caused by destruction of retinal cells through irreversible lesion growth that is driven by excessive complement activation.4 C3 is the only target that can precisely control the complement cascade due to its central location. There are currently no approved treatments for GA.
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 U.S. Food and Drug Administration (FDA) for the treatment of geographic atrophy.
About Apellis
Apellis Pharmaceuticals, Inc. is a global biopharmaceutical company that is committed to leveraging courageous science, creativity, and compassion to deliver life-changing therapies. Leaders in complement, we ushered in the first new class of complement medicine in 15 years with the approval of the first and only targeted C3 therapy. We are advancing this science to continually develop transformative medicines for people living with rare, retinal, and neurological diseases. For more information, please visit http://apellis.com or follow us on Twitter and LinkedIn.
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 Securities and Exchange Commission on February 28, 2022 and the risks described in other filings that Apellis may make with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Apellis specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
Media Contact:
Lissa Pavluk
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617.977.6764
Investor Contact:
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617.599.8178
| 1 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. 2 Wong 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. 3 Lindblad AS, et al, and AREDS Research Group. Arch Ophthalmol. 2009;127(9):1168-1174. 4 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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