Cingulate
Inc. (NASDAQ:
CING), a biopharmaceutical company utilizing its
proprietary Precision Timed Release™ (PTR™) drug delivery platform
technology to build and advance a pipeline of next-generation
pharmaceutical products, announced today that it will be attending
DCAT Week (Drug, Chemical & Associated Technologies
Association) March 18-21, 2024, in Midtown Manhattan.
Cingulate Chairman and CEO Shane J. Schaffer, and Cingulate COO
Laurie A. Myers, will be joined at the DCAT by Global
PharmaPartners, INC. (also known worldwide as “GPP”) to host
meetings regarding Cingulate’s pipeline and product portfolio,
including its lead Phase 3 candidate CTx-1301 (dexmethylphenidate)
for the treatment of attention deficit/hyperactivity disorder
(ADHD), and CTx-2103 (buspirone) for the treatment of anxiety.
“Cingulate is excited to be attending DCAT this year with Global
PharmaPartners, Inc. to seek out business partnerships with
excellent co-development/commercial parties, and we believe it’s an
excellent venue to discuss our leading assets, pipeline, and
disruptive drug delivery platform technology,” Schaffer said.
What: DCAT Week 2024
Where: Omni Berkshire Place Hotel: 21 E 52nd St
Madison Ave, New York City, NY 10022-5389
When: March 18-21, 2024
Contact: To arrange meetings with Cingulate
leadership please contact Jonathan Camerer with Global
PharmaPartners (GPP): 417-576-5082
jonathancamerer@globalpharmapartners.com
About Attention Deficit/Hyperactivity Disorder
(ADHD)ADHD is a chronic neurobiological and developmental
disorder that affects millions of children and often continues into
adulthood. The condition is marked by an ongoing pattern of
inattention and/or hyperactivity-impulsivity that interferes with
functioning or development. In the U.S., approximately 6.4 million
children and adolescents (11 percent) aged under the age of 18 have
been diagnosed with ADHD. Among this group, approximately 80
percent receive treatment, with 65-90 percent demonstrating
clinical ADHD symptoms that persist into adulthood. Adult ADHD
prevalence is estimated at approximately 11 million patients (4.4
percent), almost double the size of the child and adolescent
segment combined. However, only an estimated 20 percent receive
treatment.
About CTx-1301Cingulate’s lead candidate,
CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery
platform to create a breakthrough, multi-core formulation of the
active pharmaceutical ingredient dexmethylphenidate, a compound
approved by the FDA for the treatment of ADHD. Dexmethylphenidate
is part of the stimulant class of medicines and increases
norepinephrine and dopamine activity in the brain to affect
attention and behavior. While stimulants are the gold standard of
ADHD treatment due to their efficacy and safety, the long-standing
challenge continues to be providing patients with an entire
active-day duration of action. CTx-1301 is designed to precisely
deliver three releases of medication at the predefined time, ratio,
and style of release to optimize patient care in one tablet. The
result is a rapid onset and entire active-day efficacy, with the
third dose being released around the time when other
extended-release stimulant products begin to wear off.
About AnxietyAnxiety disorders are the most
common mental health concern in the U.S.1 Anxiety is the
feeling of fear that occurs when faced with threatening or
stressful situations or can be endogenous and not have an
identified stressor. It can be a normal response when confronted
with danger, but, if severe and chronic and affects functioning, it
could be regarded as an anxiety disorder. An estimated 31 percent
of U.S. adults experience an anxiety disorder at some time in their
lives.2 People may live with anxiety for years before they are
diagnosed or treated. The global COVID-19 crisis has exacerbated
the diagnosis and treatment of anxiety and anxiety related
disorders and as a result is a priority within the class of unmet
medical needs in mental health.
About CTx-2103 CTx-2103 is a novel,
trimodal, extended-release tablet of buspirone that incorporates
Cingulate’s proprietary PTR™ drug delivery platform. CTx-2103 is
being studied for the treatment of anxiety and/or anxiety-related
disorders. Buspirone, an azapirone derivative and a 5-HT1A partial
agonist, was the first non-benzodiazepine anxiolytic introduced for
the treatment of generalized anxiety disorder. Buspirone may
exhibit a decreased side-effect profile compared to other
anxiolytic treatments. Unlike benzodiazepines and barbiturates,
there is no associated risk of physical dependence or withdrawal
with buspirone use due to the lack of effects on gamma-aminobutyric
acid receptors.
About Precision Timed Release™ (PTR™) Platform
TechnologyCingulate is developing ADHD and anxiety
disorder product candidates capable of achieving true once-daily
dosing using Cingulate’s innovative PTR drug delivery platform
technology. It incorporates a proprietary Erosion Barrier Layer
(EBL) providing control of drug release at precise, pre-defined
times with no release of drug prior to the intended release. The
EBL technology is enrobed around a drug-containing core to give a
tablet-in-tablet dose form. It is designed to erode at a controlled
rate until eventually the drug is released from the core tablet.
The EBL formulation, Oralogik™, is licensed from BDD Pharma.
Cingulate intends to utilize its PTR technology to expand and
augment its clinical-stage pipeline by identifying and developing
additional product candidates in other therapeutic areas in
addition to Anxiety and ADHD where one or more active
pharmaceutical ingredients need to be delivered several times a day
at specific, predefined time intervals and released in a manner
that would offer significant improvement over existing therapies.
To see Cingulate’s PTR Platform,
click here.
About Cingulate Inc.Cingulate Inc. (NASDAQ:
CING), is a biopharmaceutical company utilizing its proprietary PTR
drug delivery platform technology to build and advance a pipeline
of next-generation pharmaceutical products, designed to improve the
lives of patients suffering from frequently diagnosed conditions
characterized by burdensome daily dosing regimens and suboptimal
treatment outcomes. With an initial focus on the treatment of ADHD,
Cingulate is identifying and evaluating additional therapeutic
areas where PTR technology may be employed to develop future
product candidates, including to treat anxiety disorders. Cingulate
is headquartered in Kansas City. For more information,
visit Cingulate.com.
Forward-Looking Statements This press
release contains “forward-looking statements” within the meaning of
Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended. These
forward-looking statements include all statements, other than
statements of historical fact, regarding our current views and
assumptions with respect to future events regarding our business,
including statements with respect to our plans, assumptions,
expectations, beliefs and objectives with respect to product
development, clinical studies, clinical and regulatory timelines,
market opportunity, competitive position, business strategies,
potential growth opportunities and other statements that are
predictive in nature. These statements are generally identified by
the use of such words as “may,” “could,” “should,” “would,”
“believe,” “anticipate,” “forecast,” “estimate,” “expect,”
“intend,” “plan,” “continue,” “outlook,” “will,” “potential” and
similar statements of a future or forward-looking nature. Readers
are cautioned that any forward-looking information provided by us
or on our behalf is not a guarantee of future performance. Actual
results may differ materially from those contained in these
forward-looking statements as a result of various factors disclosed
in our filings with the Securities and Exchange Commission (SEC),
including the “Risk Factors” section of our Annual Report on Form
10-K filed with the SEC on March 10, 2023. All forward-looking
statements speak only as of the date on which they are made, and we
undertake no duty to update or revise any forward-looking
statements, whether as a result of new information, future events
or otherwise, except to the extent required by law.
Investor & Public Relations:Thomas
DaltonVice President, Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301Matt
KrepsDarrow Associatesmkreps@darrowir.com(214)
597-8200
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