Gemini Therapeutics, Inc. (Nasdaq: GMTX), a clinical stage
precision medicine company developing innovative treatments for
genetically-defined age-related macular degeneration (AMD), today
announced updates from its ongoing phase 2a clinical studies of
GEM103 and strategic evaluation of GEM103’s clinical development
program.
GEM103 Phase 2a ReGAtta Study
Update
Ongoing analysis of the 62 patients enrolled in the ReGAtta
study continues to show that more than nine months of GEM103
exposure has been generally well-tolerated, able to durably reduce
biomarkers of complement activation, and able to maintain
supraphysiological levels of Complement Factor H (CFH). ReGAtta, an
open-label, non-controlled study, was designed to evaluate GEM103’s
safety and pharmacokinetics (PK) over multiple intravitreal
injections.
GEM103 Phase 2a as an Add-On to
Anti-VEGF Therapy for the Treatment of Wet AMD Study
Update
In December 2021, the Company received six-month data for the 50
patients enrolled in the wet AMD study. This study was designed to
investigate the safety and tolerability of GEM103 as an adjunct to
standard of care aflibercept therapy, with patients randomized 2:1
between a GEM103 plus aflibercept arm and a sham comparator plus
aflibercept arm. Interim analysis showed that intravitreal GEM103
plus aflibercept was generally well-tolerated, and the safety
profile was generally consistent with the sham plus aflibercept
arm. Patients in this study were dosed every other month
concurrently with aflibercept. CFH levels remained supraphysiologic
and greater than five times above baseline at the trough timepoints
throughout the six months.
GEM103 Study Plans
Having achieved the ReGAtta study’s primary goal of assessing
GEM103’s safety and tolerability, as well as the primary goal of
assessing GEM103’s safety and tolerability as an add-on to
aflibercept for the treatment of wet AMD, the Company will end both
of these ongoing Phase 2a studies with patients returning for a
final safety visit.
“The ReGAtta and wet AMD clinical studies have achieved their
intended purpose of evaluating GEM103’s safety and tolerability,
and have also provided data indicating that GEM103 had biological
activity and sustained supraphysiologic PK levels at both monthly
and every-other-month doses,” stated Jason Meyenburg, Gemini’s
Chief Executive Officer. “We want to express our gratitude to the
patients who participated in these studies as well as the
investigators and site staff conducting the studies. We are
actively evaluating next steps with GEM103’s continued clinical
development and intend to provide an update by the end of the first
quarter 2022.”
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 has been evaluated 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 is also working to advance a potentiating
antibody for CFH, GEM307, towards 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 the success, cost, timing and status of our product
development activities and clinical trials, the timing of
anticipated announcements of updates with respect to our product
candidates and the timing to commence any potential 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, including serious adverse events, resulting from the
administration of our product candidates, our ability to obtain and
maintain regulatory approval for our product candidates.
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 the 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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Argot Partners Sherri Spear 212-600-1902
gemini@argotpartners.com
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