-Topline data expected in late 2021
Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage
precision medicine company developing innovative treatments for
genetically-defined age-related macular degeneration (AMD), today
announced the completion of enrollment in its Phase 2a trial
advancing GEM103 as a potential add-on therapy for patients
suffering from wet AMD and requiring continued anti-vascular
endothelial growth factor (anti-VEGF) treatment who have, or may be
at risk for, macular atrophy (MA). Topline data related to safety,
tolerability, effect on intraocular complement factor H (CFH)
levels and disease-relevant biomarkers of complement regulation is
expected in late 2021.
“Both physicians and patients recognize the limitations of
anti-VEGF treatment, with approximately a third of patients
developing reduced visual acuity and MA over time,” said Samuel
Barone, M.D., Chief Medical Officer of Gemini Therapeutics. “The
team’s ability to overenroll the study highlights the unmet need
and the potential for GEM103 to address these suboptimal outcomes
in the setting of regular anti-VEGF therapy and its subsequent
depletion in CFH levels causing complement dysfunction.”
“Achieving our enrollment completion target for this trial is
another milestone in our GEM103 program’s progress, and we
anticipate additional data in 2021 to provide critical information
on GEM103’s safety, pharmacokinietcs and biological activity in
patients with either dry AMD or those receiving anti-VEGF treatment
for wet AMD,” said Jason Meyenburg, Chief Executive Officer of
Gemini Therapeutics. “We look forward to releasing data from this
study in patients with wet AMD before year end as we continue to
evaluate CFH’s role as the primary endogenous complement regulator
and it’s ability to restore retinal homeostasis in AMD.”
About the Phase 2a Study of Repeat Intravitreal Injections of
GEM103 in Neovascular Age-related Macular Degeneration
The ongoing Phase 2a, multicenter, multiple-dose study in
subjects with Neovascular Age-related Macular Degeneration (nAMD)
with or at risk for macular atrophy, is designed to investigate the
safety and tolerability of GEM103 as an adjunct to standard of care
aflibercept therapy. The study is designed to enroll approximately
45 patients randomized 2:1 between GEM103 plus aflibercept and sham
plus aflibercept arms, with treatment administered via intravitreal
injection every other month for twelve months. CFH levels and
disease relevant biomarkers of complement regulation are determined
from aqueous humor sampling throughout the study with visual acuity
and macular atrophy size measured at defined dosing dates.
About GEM103
Gemini’s lead program, GEM103, a full-length recombinant
complement factor H (rCFH) protein, is believed to be the first
ever recombinant native complement regulator. GEM103 delivered by
intravitreal injection is designed to address both complement
hyperactivity and restore retinal health in patients with AMD. In a
genetically-defined subset of AMD patients, GEM103 may circumvent
dysfunctional CFH loss-of-function variants and slow the
progression of their retinal disease. In patients undergoing
anti-VEGF treatment, GEM103 may help regulate the hyperactive
amplification of the alternative pathway believed to lead to cell
loss and macular atrophy. The U.S. Food and Drug Administration
(FDA) granted Fast Track Designation for GEM103 for the treatment
of dry AMD in patients with CFH loss of function gene variants.
About Wet Age-Related Macular Degeneration (AMD)
Age-related macular degeneration (AMD) is a progressive retinal
disease affecting millions of older adults, and the leading cause
of irreversible blindness in the western world. Symptoms, which
include blurry vision, loss of night vision and loss of central
vision, make activities of daily living such as reading, driving
and even recognizing faces progressively more difficult.
Third-party reports indicate there are approximately 16 million
patients with AMD in the United States alone. Wet AMD is the most
severe form characterized by neovascularization of the retina,
leading to significant loss in visual acuity and rapid progression
to blindness. There are approximately 1.4 million patients with wet
AMD in the United States and over 2.5 million patients in the
European Union. Wet AMD is most common in individuals over the age
of 50, with increasing incidence every decade thereafter. Current
anti-VEGF therapies have significantly changed the landscape for
treatment of wet AMD, becoming the standard of care due to their
ability to prevent progression of vision loss in the majority of
patients. However, there is still no approved therapy for patients
with wet AMD who have or may be at risk for vision loss from
macular atrophy associated with ongoing need for anti-VEGF
treatment.
About Gemini Therapeutics
Gemini Therapeutics is a clinical stage precision medicine
company developing novel therapeutic compounds to treat genetically
defined age-related macular degeneration (AMD). Gemini’s lead
candidate, GEM103, is a recombinant form of human complement factor
H protein (CFH) and is designed to address both complement
hyperactivity and restore retinal health in patients with AMD.
GEM103 is currently in a Phase 2a trial in dry AMD patients with a
CFH risk variant and a Phase 1/2a study in patients with
neovascular age-related macular degeneration with or at risk for
macular atrophy. The Company has generated a rich pipeline
including recombinant proteins, gene therapies, and monoclonal
antibodies and is advancing a potentiating antibody for CFH,
GEM307, into clinical development for treatment of systemic
diseases.
For more information, visit www.geminitherapeutics.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20210513005174/en/
Gemini Investor Contact: Argot Partners Sherri Spear
212-600-1902 gemini@argotpartners.com
Gemini Media Contact: Argot Partners Joshua R. Mansbach
212-600-1902 gemini@argotpartners.com
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