Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global
biopharmaceutical company and leader in targeted C3 therapies,
today announced that 10 abstracts were accepted for presentation at
the virtual Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting to be held May 1-7, 2021. These abstracts
feature a breadth of data, from presentations that demonstrate the
potential of AI to analyze the growth of GA lesions, to new safety
and efficacy data for pegcetacoplan, an investigational targeted C3
therapy, in GA.
“New imaging approaches, AI-based technologies, and ultimately
the development of new medicines will transform the treatment of
geographic atrophy,” said Federico Grossi, M.D., Ph.D., Chief
Medical Officer of Apellis. “Our data across these disciplines at
ARVO exemplify our leadership in the retina and underscore the
potential of pegcetacoplan to become the first medicine for people
living with GA, a relentless disabling disease.”
The five oral presentations include studies that evaluated the
use of AI to identify, monitor, and predict the growth of GA
lesions. The analyses were performed on retinal scans from the
positive Phase 2 FILLY study, which showed that pegcetacoplan
reduced the growth rate of GA lesions, and were conducted in
collaboration with the Ophthalmic Image Analysis (OPTIMA) group at
the Medical University of Vienna, one of the world’s leading data
analysis laboratories for retinal diseases.
“Our collaboration showed that AI can distinctly and reliably
measure GA disease progression,” said Ursula Schmidt-Erfurth, M.D.,
professor and chair of the Department of Ophthalmology at the
University Eye Hospital, Vienna, Austria. “The results support the
use of AI analytics as an ideal tool to evaluate disease activity
as well as therapeutic efficacy in GA.”The oral presentations from
the AI collaboration include:
- AI-Based Quantification of Photoreceptor Maintenance in the
Treatment of Geographic Atrophy Secondary to AMD in the FILLY Trial
– May 2, 11:15 a.m. - 12:45 p.m. ET
- SD-OCT Based Analysis of Treatment Effects on Geographic
Atrophy Secondary to AMD in the FILLY Trial of Pegcetacoplan – May
2, 11:15 a.m. - 12:45 p.m. ET
- Monitoring GA Lesion Size on Optical Coherence Tomography (OCT)
Using Automated Deep Learning-Based Image Segmentation in the FILLY
Phase 2 Clinical Trial – May 2, 11:15 a.m. - 12:45 p.m. ET
- Topographic Effects on AI Quantified Regional Progression in
the FILLY Trial of Pegcetacoplan for Treatment of Geographic
Atrophy Secondary to AMD – May 3, 4:30 p.m. - 6:00 p.m.
ET
- Predictive Identification of the Fastest Progressing Geographic
Atrophy Lesions Based on Deep Learning in the Phase 2 FILLY
Clinical Trial of Pegcetacoplan – May 3, 4:30 p.m - 6:00 p.m.
ET
Apellis abstracts regarding the safety and efficacy of
pegcetacoplan and unmet need in GA include:
- A Phase 1b Multi-Center, Open Label, Single-Arm Safety Study of
Intravitreal Pegcetacoplan Supporting the Phase 3 DERBY and OAKS
Studies for Geographic Atrophy: A Solution to “Tarmac Delay"
– Poster Abstract – May 1, 10:15 a.m. - 12:00 p.m. ET
- Safety of Intravitreal Pegcetacoplan in Patients with
Neovascular Age-Related Macular Degeneration Receiving Anti-VEGF
Therapy – Poster Abstract – May 3, 4:30 p.m. - 6:15 p.m. ET
- Evaluation of Geographic Atrophy Secondary
to Age-Related Macular Degeneration in Clinical
Practice: Analysis of the AAO IRIS® Registry – Poster Abstract –
May 4, 2:15 p.m. - 4:00 p.m. ET
- Ocular Distribution of Pegcetacoplan in Rabbits Following a
Single Intravitreal Injection. – Poster Abstract – May 5, 9:00
- 10:45 a.m. ET
- Impact of Pegcetacoplan on Progression of Nascent Atrophy in
Age-Related Macular Degeneration (AMD) – Paper Abstract – May
7, 4:15 p.m. - 5:45 p.m. ET
About OPTIMAThe Ophthalmic Image Analysis
(OPTIMA) group at the Medical University of Vienna is a leading
data analysis laboratory for retinal diseases. OPTIMA is a
multidisciplinary group in retinology, computer science, and
medical physics that develops computerized analysis methods for
ophthalmic images and aims to individualize and lower treatment
needs for patients affected by retinal diseases.
About PegcetacoplanPegcetacoplan 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 is a synthetic cyclic peptide
conjugated to a polyethylene glycol polymer that binds specifically
to C3 and C3b. Pegcetacoplan is being evaluated in several clinical
studies across hematology, ophthalmology, nephrology, and
neurology. Marketing applications for pegcetacoplan for paroxysmal
nocturnal hemoglobinuria (PNH) are under review by the U.S. Food
and Drug Administration (FDA), which has granted the application
Priority Review designation, and the European Medicines Agency
(EMA). Pegcetacoplan was granted Fast Track designation by the
U.S. Food and Drug Administration (FDA) for the treatment of
geographic atrophy and received orphan drug designation for the
treatment of C3G by the FDA and European Medicines Agency. For
additional information regarding pegcetacoplan clinical
trials, visit https://apellis.com/our-science/clinical-trials.
About Geographic Atrophy (GA) GA is an
advanced form of age-related macular degeneration (AMD), a leading
cause of blindness. GA lesions affect the central portion of the
retina, known as the macula, which is responsible for central
vision. Excessive complement activation drives irreversible lesion
growth in GA1, and C3 is the only target to precisely control
complement overactivation. 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 in the United States and 5 million people have GA
globally.2.3 There are currently no approved treatments
for GA.
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 targeted C3 therapies,
we aim to develop transformative therapies for a broad range of
debilitating diseases that are driven by excessive activation of
the complement cascade, including those within hematology,
ophthalmology, nephrology, and neurology. For more information,
please visit http://apellis.com.
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 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 company’s 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 company’s 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, IC-MPGN, ALS 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’ Annual Report on Form 10-K filed with
the Securities and Exchange Commission on February 25,
2021 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.
Contacts:
ApellisMedia:Mark
Dolemedia@apellis.com617.997.3484
Investors: Argot
Partnersapellis@argotpartners.com212.600.1902
____________________________________________
1 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.
2 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.
3 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.
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