WALTHAM Mass., July 07, 2020 (GLOBE NEWSWIRE) -- Apellis PharmaceuticalsInc., (NASDAQ:APLS), a global biopharmaceutical company pioneering targeted C3 therapies, today announced that it completed enrollment in the Phase 3 DERBY and OAKS studies investigating intravitreal pegcetacoplan (APL-2), a targeted C3 therapy, for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). GA causes blindness and is a progressive complement-driven eye disease1,2 that affects approximately five million people globally.3,4 There are no approved therapies for GA.
Completing enrollment in the Phase 3 DERBY and OAKS studies is a critical milestone that moves us one step closer to bringing the first treatment for geographic atrophy to patients. We are extremely grateful to all patients participating in these groundbreaking studies, said Federico Grossi, M.D., Ph.D., Chief Medical Officer of Apellis. People living with GA need a treatment and we believetargeting the complement system at C3 with pegcetacoplan has the potential to control the excessive complement activation that drives the irreversible growth of GA lesions that cause blindness. We look forward to seeing top-line results in the third quarter of 2021.
A total of 1,259 patients are enrolled in DERBY and OAKS, which are pivotal randomized Phase 3 studies designed to compare the efficacy and safety of intravitreal pegcetacoplan with sham treatment in patients with GA secondary to AMD. The primary objective of the studies is to evaluate the reduction in growth of GA lesion size, measured by fundus autofluorescence (FAF) at month 12 compared to baseline.
Geographic atrophy leads to irreversible vision loss, a decline in the quality of life, and remains a major unmet need for our patients. Achieving this critical milestone reflects the importance of bringing this targeted C3 therapy to our GA patients. I want to thank my co-investigators for completing the enrollment of DERBY and OAKS, especially during the ongoing pandemic. I look forward to seeing the results next year with the hope that pegcetacoplan willenable clinicians to treat this debilitating disease,said Jeffrey S. Heier, MD, Principal Investigator of the DERBY study and Co-President & Medical Director,Director of Retinal Research,Ophthalmic Consultants of Boston.
In July 2018, the U.S. Food and Drug Administration (FDA) granted pegcetacoplan Fast Track Designation for the treatment of GA. The Phase 3 DERBY and OAKS studies were initiated based on positive results from the Phase 2 FILLY study, which showed that monthly pegcetacoplan treatment resulted in a 29% (p=0.008) reduction in the rate of GA lesion growth compared to sham injections at 12 months.
For more information about the DERBY and OAKS studies, visit http://www.clinicaltrials.gov: (NCT03525600) and (NCT03525613).
About Pegcetacoplan (APL-2)Pegcetacoplan is the only investigational targeted C3 therapy in late-stage clinical trials. It is designed to control excessive complement activation, which can lead to the onset and progression of many serious diseases. Pegcetacoplan is a synthetic cyclic peptide conjugated to a polyethylene glycol polymer that binds specifically to C3 and C3b.Apellis is evaluating pegcetacoplan in several clinical studies including geographic atrophy (GA), paroxysmal nocturnal hemoglobinuria (PNH), cold agglutinin disease, and C3 glomerulopathy. Pegcetacoplan was granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of GA and the treatment of PNH. For additional information regarding our clinical trials, visithttps://apellis.com/our-science/clinical-trials/.
About Geographic Atrophy (GA) GA is an advanced form of age-related macular degeneration (AMD), the leading cause of blindness. Excessive complement activation drives the irreversible lesion growth in GA5, and C3 is the only target to precisely control complement overactivation. Pegcetacoplan, studied in early and late-stage trials comprising a total of approximately 1500 patients, is the only targeted C3 inhibitor being evaluated in patients to control lesion growth in GA.6
GA lesions affect the central portion of the retina, known as the macula, which is responsible for central vision. GA is progressive and irreversible, leading to central visual impairment and permanent loss of vision. Based on published studies, approximately one million people have GA inthe United States and 5 million people have GA globally.1,2 There are currently noapproved treatments for GA.
About DERBY and OAKSDERBY (621 patients enrolled) and OAKS (638 patients enrolled) are Phase 3, multicenter, randomized, double-masked, sham-controlled studies to compare the efficacy and safety of intravitreal pegcetacoplan with sham injections in patients with GA secondary to AMD. The primary objective of the studies is to evaluate the efficacy of pegcetacoplan compared to sham injection in patients with GA secondary to AMD assessed by change in the total area of GA lesions from baseline as measured by fundus autofluorescence (FAF).
About FILLYThe FILLY study was a 246-patient, Phase 2, multicenter, randomized, single-masked, sham-controlled clinical trial evaluating pegcetacoplan in patients with GA secondary to AMD conducted at over 40 clinical sites in the United States, Australia and New Zealand. Pegcetacoplan was administered as an intravitreal injection monthly or every other month (EOM) for 12 months, followed by six months of monitoring after the end of treatment. The primary efficacy endpoint was the change in GA lesion area from baseline to month 12 compared to sham.
In this study, pegcetacoplan met its primary endpoint of reducing the growth rate of the GA lesion (measured as square root transformation of GA lesion area) compared to sham after 12 months of treatment. Pegcetacoplan administered monthly via intravitreal injection showed a 29% (p=0.008) reduction in the rate of GA lesion growth compared to sham after 12 months of treatment. With every other month administration of pegcetacoplan, a 20% (p=0.067) reduction was observed compared to sham. Statistical significance was defined as p<0.1 for this study.
Pegcetacoplan was generally well-tolerated in the Phase 2 FILLY trial. Over the full 18-month study period, a total of 26 cases of exudative AMD were reported by the investigators. These were seen more frequently in the pegcetacoplan-treated patients (18 in the monthly treatment group, 7 in the every other month treatment group and 1 in the sham control group). No negative impact on visual acuity was observed. The results of the FILLY study were published in Ophthalmology, the journal of the American Academy of Ophthalmology.
About ApellisApellis Pharmaceuticals, Inc.is a clinical-stage biopharmaceutical company focused on the development of novel therapeutic compounds for the treatment of a broad range of life-threatening or debilitating autoimmune diseases based upon complement immunotherapy through the inhibition of the complement system at the level of C3. Apellis is the first company to advance chronic therapy with a C3 inhibitor into clinical trials. For additional information about Apellis and pegcetacoplan, please visithttp://www.apellis.com.
Apellis Forward-Looking StatementStatements 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 relating to the implications of preliminary clinical data. 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 companys clinical trials will be fully enrolled and completed when anticipated; whether preliminary or interim results from a clinical trial will be predictive of the final results of the trial; whether results obtained in preclinical studies and clinical trials will be indicative of results that will be generated in future clinical trials; whether pegcetacoplan will successfully advance through the clinical trial process on a timely basis, or at all; whether the results of the companys clinical trials will warrant regulatory submissions and whether pegcetacoplan will receive approval from the FDA or equivalent foreign regulatory agencies for GA, PNH, CAD, C3G or any other indication when expected or at all; whether, if Apellis products receive approval, they will be successfully distributed and marketed; and other factors discussed in the Risk Factors section of Apellis Quarterly Report on Form 10-Q filed with theSecurities and Exchange CommissiononApril 29, 2020and the risks described in other filings that Apellis may make with theSecurities 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:Mark Dolemedia@apellis.com617.997.3484
Investor Contact: Sam Martin/Maghan MeyersArgot Partnerssam@argotpartners.com/maghan@argotpartners.com212.600.1902
_______________________________________
1 Weber, BHF, Issa, PC, et al. The Role of the Complement System in Age-Related Macular Degeneration. Dtsch Arztebl Int 2014; 111(8): 1338. 2 Heesterbeek, TJ, Lechanteur YTE, et al. Complement activation levels are related to disease stage in AMD. Invest Ophthalmol Vis Sci. 2020;61(3):18. 3 Rudnicka AR, Jarrar Z, Wormald R, et al. Age and gender variations inage-related macular degenerationprevalence in populations of European ancestry: a meta-analysis. Ophthalmology 2012;119:571580.4 Wong WL, Su X, Li X, et al. Global prevalence ofage-related macular degenerationand disease burden projection for 2020 and 2040: a systematic review and meta-analysis. Lancet Glob Health 2014;2:e106116.5 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;198:223261. 6Yates, JRW, Sepp T, et al. Complement C3 Variant and the Risk of Age-Related Macular Degeneration. N Engl J Med 2007;357.
Here is the original post:
Apellis Completes Enrollment in Two Phase 3 Studies of the Targeted C3 Therapy, Pegcetacoplan, in Patients with Geographic Atrophy (GA) -...
- Types of Blindness, Causes, and Their Treatment - Healthline - March 28th, 2025
- Types of blindness: Partial, total, congenital, and more - March 28th, 2025
- International collaborations helping understand the physical activity levels and well-being of children with visual impairment - Murdoch University - March 28th, 2025
- Revel in the Rainbow: Color-Blindness-Correcting Glasses Debut at Wooden Shoe Festival - Portland Monthly - March 28th, 2025
- Prevent Blindness Declares April as Women's Eye Health and Safety Month, Providing Free Educational Resources to the Public and Professionals - PR Web - March 28th, 2025
- Partial blindness hasn't stopped Oklahoma State's Stailee Heard from leading the Cowgirls into NCAAs - The Washington Post - March 28th, 2025
- Nine out of ten cases of blindness caused by glaucoma could be prevented through annual check-ups - Euro Weekly News - March 28th, 2025
- The silent sight thief: The devastating effects of glaucoma on mental health and quality of life - News24 - March 28th, 2025
- Rosie O'Donnell Celebrates Her 63rd Birthday After Move to Ireland as She Slams 'Willful Blindness' in Trump Administration - AOL - March 28th, 2025
- Partial blindness hasn't stopped Oklahoma State's Stailee Heard from leading the Cowgirls into NCAAs - Eagle-Tribune - March 28th, 2025
- The Longevity Wake-Up Call And The Blindness Of Leadership To It - Forbes - February 24th, 2025
- Album Review: Blindness // The Murder Capital - The Indiependent - February 24th, 2025
- The Murder Capital - Blindness - Northern Transmissions - February 24th, 2025
- The Murder Capital: Blindness review - independent pop | Indie - The Line of Best Fit - February 24th, 2025
- Prevent Blindness Kicks Off Second Annual "Retinopathy of Prematurity (ROP) Awareness Week," Feb. 24- March 2, 2025, as Part of its ROP... - February 24th, 2025
- Prevent Blindness Kicks Off Second Annual Retinopathy of Prematurity Awareness Week - Vision Monday - February 24th, 2025
- Gene therapy for rare childhood blindness shows lasting vision gains - R&D World - February 24th, 2025
- The Murder Capital's Blindness: A Voice of Significance in an Era Craving Authentic Discourse - Indie Is Not A Genre - February 24th, 2025
- Albums Of The Week: The Murder Capital | Blindness - Tinnitist - February 24th, 2025
- After Maine native testifies before Congress, Elon Musk targets his disability - Press Herald - February 24th, 2025
- Ozempic could BLIND you - it damages veins in the eye, major study finds - Daily Mail - February 24th, 2025
- Cerebral Venous Thrombosis Presenting With Binocular Blindness and Bilateral Sensorineural Hearing Loss - Cureus - February 24th, 2025
- Treatment for horses may lead to therapy for type of blindness - Mid Florida Newspapers - February 24th, 2025
- The Murder Capital: Blindness album review - Louder Than War - February 24th, 2025
- 'First in the world': London doctors cure blindness in children born with a genetic condition - WION - February 24th, 2025
- Doctors cure rare blindness in infants with gene therapy - NewsBytes - February 24th, 2025
- Gene therapy new trial treats rare blindness in children - Daily Jang - February 24th, 2025
- Ozempic Blindness Could Be Rare but Real: What Experts Say About the Risk - ZME Science - February 24th, 2025
- Parents of boy with rare eye condition hail amazing results of gene therapy - Yahoo News UK - February 24th, 2025
- Myths and Assumptions about Blindness - BBC.com - February 24th, 2025
- Man accused of beating victim, causing permanent blindness in one eye - KAIT - February 15th, 2025
- Scientists Find Link Between Weight Loss Drugs and Blindness - AOL - February 15th, 2025
- Treatment for horses may lead to therapy for type of blindness - University of Florida - February 15th, 2025
- How Ageism Impacts Adults with Low Vision - National Council on Aging - February 15th, 2025
- Ozempic and other weight loss drugs may be linked to conditions that could lead to blindness, study says - Quartz - February 15th, 2025
- Treatment for horses may lead to therapy for type of blindness - Phys.org - February 15th, 2025
- Treatment for Horses May Lead to Therapy for Type of Blindness - Morning Ag Clips - - February 15th, 2025
- Foundation Fighting Blindness Celebrates 20 Years of VisionWalk - PR Newswire - February 15th, 2025
- Woman Victim of 'Lash Blindness'Shock at How She Looks Without Them - Newsweek - February 15th, 2025
- Some Ozempic users are losing their vision - but scientists dont know why - The Independent - February 15th, 2025
- Those with visual impairments or blindness tackling the trails at Pico Mountain - WCAX - February 15th, 2025
- Prevent Blindness Issues Call for Nominations for the 2025 Jenny Pomeroy Award for Excellence in Vision and Public Health, and Rising Visionary Award... - February 15th, 2025
- Medical warning: Ozempic and Mounjaro may be linked to vision loss - India Today - February 15th, 2025
- New research links Ozempic to vision loss and risk of blindness - MSN - February 15th, 2025
- Ozempic Blindness: Weight Loss Drugs Linked to This Condition, Experts Warn - Tech Times - February 15th, 2025
- Ozempic Blindness Lawsuit Mounts: Shocking Side Effect Of Weight Loss Drug Is 'Eye Stroke,' What You Need To Know - IBTimes UK - February 15th, 2025
- The Politics Of Erasure: Gaza, Genocide, And The Wests Wilful Blindness OpEd - Eurasia Review - February 15th, 2025
- WHO launches new initiative to tackle the main cause of vision impairment - December 19th, 2024
- Blindness Advocates on Why There Should Be Audio Description Oscars - Variety - December 19th, 2024
- Diabetic retinopathy is treatable and preventable but only if you catch it in time - USA TODAY - December 19th, 2024
- AI: Could it help prevent blindness in diabetics? - BBC.com - December 19th, 2024
- Health Officials Investigate Rare Form of Blindness Tied to Ozempic - Gizmodo - December 19th, 2024
- Ozempic Could Be Blinding People Trying to Lose Weight - VICE - December 19th, 2024
- What is retinitis pigmentosathe vision disorder in the movie Blink? - National Geographic - December 19th, 2024
- VR shows promise in aiding navigation of people with blindness or low vision - Health Tech World - December 19th, 2024
- Ozempic could be linked to a common cause of sudden blindness, study finds - Quartz - December 19th, 2024
- New virtual realitytested system shows promise in aiding navigation of people with blindness or low vision - Tech Xplore - December 19th, 2024
- Ex-meth user who gouged her own eyeballs out while high says she is happier years after nightmarish episode - New York Post - December 19th, 2024
- Officials investigating link between Ozempic and eye-rotting disease that makes people blind - Daily Mail - December 19th, 2024
- Youngster to 'have eye removed' after minor fall - but NHS waitlist 'over 3 years' - NationalWorld - December 19th, 2024
- Restoring Vision: The Promise of Stem Cells in Healing Blindness - This is Local London - December 19th, 2024
- COAVS and Fred Hollows Foundation strengthen efforts to combat blindness in Pakistan - 24newshd - December 19th, 2024
- Study finds link between Ozempic and increased risk of vision loss - The Express Tribune - December 19th, 2024
- Going blind at 33 is devastating I wont see my childrens faces as they grow up - The Telegraph - December 19th, 2024
- Europol terror report reveals stark blindness about where the danger lies - Gript - December 19th, 2024
- Elton John lost his vision; signs and symptoms of eye infections that can cause blindness - The Times of India - December 6th, 2024
- Elton John's battle with blindness: How 77-year-old star's husband David Furnish guided him around premiere as - Daily Mail - December 6th, 2024
- Experimental study shows connection between COVID infection and age-related blindness - Medical Xpress - December 6th, 2024
- Elton John confirms shocking blindness after severe infection fight: I havent been able to see.. - Hindustan Times - December 6th, 2024
- Yes, an Eye Infection *Can* Lead To Vision Loss Heres How - Katie Couric Media - December 6th, 2024
- Elton John Battling Partial Blindness After Serious Eye Infection - Digital Music News - December 6th, 2024
- CU Anschutz researchers working to cure blindness through total eye transplantation - 9News.com KUSA - December 6th, 2024
- Elton John lost his vision from an eye infection. Here's why that might happenand how to prevent it - Fortune - December 6th, 2024
- Elton John announces blindness due to infection - CBS19.tv KYTX - December 6th, 2024
- David Frost: I suffer from face blindness. As a politician, being unable to identify people is agony - The Telegraph - December 6th, 2024
- Hes still standing how Elton John has survived far worse than blindness - The Telegraph - December 6th, 2024
- Foundation Fighting Blindness Partners with University of Colorado Anschutz Medical Campus and Other Leading Institutions to Secure Up to $46 Million... - December 6th, 2024
- Walmart helping low vison and blind customers shop with new app - KSLA - December 6th, 2024
- Elton John Says He Is Blind In The Right Eye Due to An Infection; What Is It All About? - Times Now - December 6th, 2024
- Trumps Win: The Blindness of Republicans and Democrats - The Times of Israel - December 6th, 2024