Apellis Pharmaceuticals, Inc. (Nasdaq: APLS) today announced data
from the GALE extension study following 3 years of continuous
treatment with SYFOVRE® (pegcetacoplan injection), the first-ever
FDA-approved treatment for geographic atrophy (GA) secondary to
age-related macular degeneration (AMD). The data were reported
during an oral presentation at the American Academy of
Ophthalmology (AAO) Annual Meeting.
“We are continuing to see increasing SYFOVRE treatment effects
year-over-year and a more than 40% reduction in nonsubfoveal lesion
growth in the third year,” said Caroline Baumal, M.D., chief
medical officer, Apellis. “Additionally, SYFOVRE is the only
treatment that offers dosing beyond 12 months, and these results
demonstrate the importance of early and continuous treatment over
time.”
SYFOVRE continued to demonstrate increasing treatment effects
over time. In Year 3, SYFOVRE (all p-values nominal):
- Reduced GA lesion growth with both monthly (35%; p<0.0001)
and every-other-month (EOM) (24%; p<0.0001) treatment compared
to the projected sham arm.
- Reduced nonsubfoveal GA lesion growth with both monthly (42%;
p<0.0001) and EOM (28%; p=0.0015) treatment compared to the
projected sham arm.
- Reduced GA lesion growth by 19% (p<0.0001) after one year of
SYFOVRE treatment (combined monthly and EOM), compared to the sham
treatment period, in patients who crossed over from the sham
group.
“These three-year data further solidify the long-term durability
of both every-other-month and monthly SYFOVRE, including the
increasing treatment effects over time,” said Jeffrey S. Heier,
M.D., presenting author and director, retina service and director,
retinal research, Ophthalmic Consultants of Boston. “GA is a
chronic disease that requires long-term management to slow its
devastating progression. With the largest dataset collected in GA,
I am very encouraged about the potential of SYFOVRE to make a
meaningful difference for patients who for so long had no
options.”
An analysis of the untreated fellow eye further validated the
treatment effects observed in Year 3. In patients with bilateral
GA, lesions are known to grow at similar rates in both eyes. The
fellow eye analysis serves as an important additional control to
assess treatment effect.
The safety profile of SYFOVRE in Year 3 remained consistent with
previously reported data. During the first year of GALE, the rate
of new-onset investigator-reported exudative AMD was 7.1% (monthly)
and 2.3% (EOM). There was one serious adverse event of ischemic
optic neuropathy (ION) in the monthly group between Months 24 to
30, which was previously reported, and one case of endophthalmitis
between Months 30 to 36. The rate of intraocular inflammation (IOI)
was 0.26% per injection from Months 0 to 36, which does not include
the four cases linked to the 2018 impurity. Zero events of retinal
vasculitis have been observed in the SYFOVRE clinical trial
program, following more than 24,000 injections to date.
Approximately 92% of patients enrolled in GALE completed the
first year of the study, demonstrating robust long-term treatment
compliance.
About the GALE Long-Term Extension StudyGALE
(n=792) is a Phase 3, multicenter, open-label, extension study to
evaluate the long-term efficacy and safety of SYFOVRE®
(pegcetacoplan injection) in patients with geographic atrophy (GA)
secondary to age-related macular degeneration (AMD). The objectives
of the study are to evaluate the long-term incidence and severity
of ocular and systemic treatment emergent adverse events as well as
change in the total area of GA lesions as measured by fundus
autofluorescence. More than 80-percent of participants who
completed the OAKS and DERBY studies entered the GALE study. GALE
also includes 10 patients who were previously enrolled in the Phase
1b study of pegcetacoplan for GA.
Patients included in the 3-year GALE lesion growth reduction
analyses were in the SYFOVRE treatment arms through Month 24 in the
OAKS and DERBY studies and remained on the same regimen in GALE.
Sham-treated patients in the Phase 3 OAKS and DERBY studies were
eligible to transition to SYFOVRE treatment in GALE after Month 24,
so a projected sham arm was used to estimate the growth of GA
lesions without treatment between Months 24 and 36. The projected
sham arm was estimated as the average 12-month mean rate of change
in the OAKS and DERBY sham arms through Month 24.
About the Phase 3 OAKS and DERBY StudiesOAKS
(n=637) and DERBY (n=621) are Phase 3, multicenter, randomized,
double-masked, sham-controlled studies comparing the efficacy and
safety of SYFOVRE® (pegcetacoplan injection) with sham injections
across a broad and heterogenous population of patients with
geographic atrophy (GA) secondary to age-related macular
degeneration (AMD). The studies evaluated the efficacy of monthly
and every-other-month SYFOVRE in patients with GA assessed by
change in the total area of GA lesions from baseline as measured by
fundus autofluorescence.
In Phase 3 studies at 24 months, both every-other-month and
monthly SYFOVRE reduced GA lesion growth with increasing effects
over time and showed a well-demonstrated safety profile.
About Geographic Atrophy (GA)Geographic atrophy
(GA) is an advanced form of age-related macular degeneration and a
leading cause of blindness worldwide, impacting more than one
million Americans and five million people worldwide.1,2 It is a
progressive and irreversible disease caused by the growth of
lesions, which destroy the retinal cells responsible for vision.
The vision loss caused by GA severely impairs independence and
quality of life by making it difficult to participate in daily
activities. On average, it takes only 2.5 years for GA lesions to
start impacting the fovea, which is responsible for central
vision.3
About SYFOVRE®
(pegcetacoplan injection)
SYFOVRE® (pegcetacoplan injection) is the first
and only approved therapy for geographic atrophy (GA). By targeting
C3, SYFOVRE is designed to provide comprehensive control of the
complement cascade, part of the body’s immune system. SYFOVRE is
approved in the United States for the treatment of GA secondary to
age-related macular degeneration.
Marketing applications are currently under review with five
regulatory agencies worldwide. A decision in the EU is expected in
early 2024, and decisions in Canada, Australia, Switzerland, and
the United Kingdom are expected in the first half of 2024.
U.S. Important Safety Information for
SYFOVRE® (pegcetacoplan
injection) CONTRAINDICATIONS
- SYFOVRE is contraindicated in patients with ocular or
periocular infections, and in patients with active intraocular
inflammation
WARNINGS AND PRECAUTIONS
- Endophthalmitis and Retinal Detachments
- Intravitreal injections, including
those with SYFOVRE, may be associated with endophthalmitis and
retinal detachments. Proper aseptic injection technique must always
be used when administering SYFOVRE to minimize the risk of
endophthalmitis. Patients should be instructed to report any
symptoms suggestive of endophthalmitis or retinal detachment
without delay and should be managed appropriately.
- Neovascular AMD
- In clinical trials, use of SYFOVRE was
associated with increased rates of neovascular (wet) AMD or
choroidal neovascularization (12% when administered monthly, 7%
when administered every other month and 3% in the control group) by
Month 24. Patients receiving SYFOVRE should be monitored for signs
of neovascular AMD. In case anti-Vascular Endothelial Growth Factor
(anti-VEGF) is required, it should be given separately from SYFOVRE
administration.
- Intraocular Inflammation
- In clinical trials, use of SYFOVRE was
associated with episodes of intraocular inflammation including:
vitritis, vitreal cells, iridocyclitis, uveitis, anterior chamber
cells, iritis, and anterior chamber flare. After inflammation
resolves, patients may resume treatment with SYFOVRE.
- Increased Intraocular Pressure
- Acute increase in IOP may occur within
minutes of any intravitreal injection, including with SYFOVRE.
Perfusion of the optic nerve head should be monitored following the
injection and managed as needed.
ADVERSE REACTIONS
- Most common adverse reactions (incidence ≥5%) are ocular
discomfort, neovascular age-related macular degeneration, vitreous
floaters, conjunctival hemorrhage.
Please see accompanying full Prescribing Information for more
information.
About Apellis Apellis Pharmaceuticals,
Inc. is a global biopharmaceutical company that combines courageous
science and compassion to develop life-changing therapies for some
of the most challenging diseases patients face. We ushered in the
first new class of complement medicine in 15 years and now have two
approved medicines targeting C3. These include the first-ever
therapy for geographic atrophy, a leading cause of blindness around
the world. We believe we have only begun to unlock the potential of
targeting C3 across serious retinal, rare, 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 the safety profile of SYFOVRE. 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 benefit/risk profile
of SYFOVRE following these reported events will impact our
commercialization efforts; whether SYFOVRE will receive approval
from foreign regulatory agencies for GA when expected or at all,
including the impact of the reported events of retinal vasculitis
on the likelihood and timing of such approvals; 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 21, 2023 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 media@apellis.com 617.977.6764
Investor Contact: Meredith
Kaya meredith.kaya@apellis.com617.599.8178
1Rudnicka 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;119:571–580.2Wong 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.
Apellis Pharmaceuticals (NASDAQ:APLS)
Gráfica de Acción Histórica
De May 2024 a Jun 2024
Apellis Pharmaceuticals (NASDAQ:APLS)
Gráfica de Acción Histórica
De Jun 2023 a Jun 2024