- Study shows well-tolerated safety profile with no increased
risk of CNV, complement regulation, reduction in inflammatory state
and supports bi-monthly dosing
Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage
precision medicine company developing innovative treatments for
genetically defined age-related macular degeneration (AMD), today
announced that Raj Maturi, M.D., Adjunct Clinical Assistant
Professor of Ophthalmology at Indiana University School of Medicine
and an investigator in the ReGAtta study, presented Gemini’s
previously released initial results from its ongoing Phase 2a study
at EURETINA 2021 Virtual held from September 9-12, 2021. The
ReGAtta study is an open-label, single-arm dose escalation study of
GEM103 in genetically-defined patients with geographic atrophy (GA)
secondary to dry AMD.
“The initial results presented at EURETINA 2021 highlight the
potential of GEM103 as a new treatment method for AMD and add to
the understanding of its safety profile, mechanism of action, and
duration, all of which will inform late-stage trial design,” said
Samuel Barone, M.D., Chief Medical Officer at Gemini. “Results thus
far demonstrate that GEM103 continues to be well-tolerated. In
addition, GEM103’s ability to regulate complement is evidenced
through a rapid and sustained reduction of biomarkers elevated in
AMD and pharmacokinetics support bi-monthly intravitreal
dosing.”
Summarized observations from the ongoing Phase 2a ReGAtta study,
as of May 2021, presented at EURETINA 2021 include the
following:
- For the 62 patients with GA enrolled, no systemic serious
adverse events related to GEM103 were observed as of the May 2021
snapshot. Ocular adverse events observed were related to the
intravitreal procedure and are commonly associated with IVT
procedure. Ocular inflammation was rare, mild and did not result in
interruption of GEM103 administration. No choroidal
neovascularization (CNV) was detected via retinal imaging.
- Repeat dosing with GEM103 resulted in rapid and sustained
increased levels of complement factor H (CFH) in aqueous humor and
supports the evaluation of every other month dosing in late-stage
development studies.
- GEM103 demonstrated the ability to regulate complement in
patients with GA, with treatment resulting in a reduction of
elevated complement biomarkers and a dose dependent reduction in
overall inflammatory state converging at 90 days. Timing of
biomarker reductions was consistent with the accumulation of CHF
with repeat dosing.
Information on Gemini Therapeutics, including GEM103 and initial
ReGAtta data, and presentations made at EURETINA 2021 Virtual are
available on Gemini Therapeutics’ website under the Investors &
Media section: Events and Presentations.
About the Phase 2a ReGAtta Study
The ongoing Phase 2a, multi-center, open-label, multiple
ascending dose study of GEM103 in genetically-defined patients with
GA secondary to dry AMD is designed to investigate safety and
tolerability, PK, exploratory ocular biomarkers, and measures of
retinal anatomy and function and not assess efficacy of GEM103 in
GA. GEM103 is delivered monthly by an intravitreal injection and PK
and biomarkers of complement regulation are determined from aqueous
humor sampling. To date, the study has enrolled 62 patients with
gene variants that have been linked to the progression of dry AMD
from early to late-stage. The study’s design allowed for imbalances
in GA baseline characteristics and does not inform GA efficacy and
does not allow comparisons with uncontrolled fellow eye with
similar imbalances.
About GEM103
Gemini’s lead program, GEM103, is a pioneering precision
medicine approach, targeting trial enrichment with genetically
defined patients. GEM103 targets a genetically defined subset of
age-related macular degeneration (AMD) patients with complement
dysregulation. Of the 15 million dry AMD patients in the United
States, approximately 40% (or six million) have variants in the
complement factor H (CFH) gene. Such loss of function variants are
associated with increased dry AMD disease risk. GEM103 is believed
to be the first ever recombinant complement regulator and is a
full-length and human, recombinant complement factor H (rCFH)
protein. When delivered by intravitreal injection, we believe
GEM103 has the potential to address unmet medical need in
genetically defined AMD patients by circumventing the complement
dysfunction resulting from CFH loss of function variants and
slowing the progression of their retina disease. 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 Dry 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. Dry AMD, which
results from an interaction of environmental and genetic risk
factors, represents about 90% of that population (or about 15
million) in the US compared to about 1.4 million with wet AMD.
Genetic risk of developing dry AMD is significant, with
approximately 70% attributable risk of advanced disease to
heritability, while aging and smoking confer the strongest
non-genetic risk. CFH risk variants occur in approximately 40% of
patients with dry AMD and these patients have a significantly
increased risk of developing the disease as well as progression
from intermediate AMD to GA. The complement system, of which CFH is
a regulator, is dysregulated in patients with these risk variants,
and results in amplification of aberrant inflammatory responses in
the eye. Over time, this dysregulation leads to damage to the
macular region of the retina.
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. Gemini 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.
Availability of Other Information About Gemini
Therapeutics
Investors and others should note that we communicate with our
investors and the public using our website
(www.geminitherapeutics.com), the investor relations website
(https://investors.geminitherapeutics.com/), and on social media
(Twitter and LinkedIn), including but not limited to investor
presentations and investor fact sheets, U.S. Securities and
Exchange Commission filings, press releases, public conference
calls and webcasts. The information that Gemini posts on these
channels and websites could be deemed to be material information.
As a result, Gemini encourages investors, the media, and others
interested in Gemini to review the information that is posted on
these channels, including the investor relations website, on a
regular basis. This list of channels may be updated from time to
time on Gemini’s investor relations website and may include
additional social media channels. The contents of Gemini’s website
or these channels, or any other website that may be accessed from
its website or these channels, shall not be deemed incorporated by
reference in any filing under the Securities Act of 1933, as
amended.
Gemini’s Forward-Looking Statements
Certain statements in this press release and the information
incorporated herein by reference may constitute “forward-looking
statements” for purposes of the federal securities laws. Our
forward-looking statements include, but are not limited to,
statements regarding our or our management team’s expectations,
hopes, beliefs, intentions or strategies regarding the future,
including those relating to the success, cost and timing of our
product development activities and clinical trials, whether such
data, when final, will be consistent with interim reported data,
the timing to commence future clinical trials, the potential
attributes and benefits of our product candidates, including
GEM103, the reliability of the interim or final results of studies
relating to safety and possible adverse effects resulting from the
administration of our product candidates, our ability to obtain and
maintain regulatory approval for our product candidates, our
projected cash runway and our ability to obtain funding for our
operations when needed. Forward-looking statements include
statements relating to our management team’s expectations, hopes,
beliefs, intentions or strategies regarding the future. In
addition, any statements that refer to projections, forecasts or
other characterizations of future events or circumstances,
including any underlying assumptions, are forward-looking
statements. The words “anticipate,” “believe,” “contemplate,”
“continue,” “could,” “estimate,” “expect,” “intends,” “may,”
“might,” “plan,” “possible,” “potential,” “predict,” “project,”
“should,” “will,” “would” and similar expressions may identify
forward-looking statements, but the absence of these words does not
mean that a statement is not forward-looking. These forward-looking
statements are based on current expectations and beliefs concerning
future developments and their potential effects. There can be no
assurance that future developments affecting us will be those that
we have anticipated. These forward-looking statements involve a
number of risks, uncertainties (some of which are beyond our
control) or other assumptions that may cause actual results or
performance to be materially different from those expressed or
implied by these forward-looking statements. These risks and
uncertainties include, but are not limited to, those factors
described under the heading “Risk Factors” in Gemini’s most recent
Annual Report on Form 10-K filed with the SEC, as well as
discussions of potential risks, uncertainties, and other important
factors included in any of our future filings with the SEC. Should
one or more of these risks or uncertainties materialize, or should
any of our assumptions prove incorrect, actual results may vary in
material respects from those projected in these forward-looking
statements. Some of these risks and uncertainties may in the future
be amplified by the ongoing COVID-19 pandemic and there may be
additional risks that we consider immaterial, or which are unknown.
It is not possible to predict or identify all such risks. Our
forward-looking statements only speak as of the date they are made,
and we do not undertake any obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as may be required under
applicable securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20210909005030/en/
Investor Contact: Argot Partners Sherri Spear
212-600-1902 gemini@argotpartners.com Media Contact: Argot
Partners Joshua R. Mansbach 212-600-1902
gemini@argotpartners.com
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