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 that it has
received guidance from the Food and Drug Administration (FDA) on
advancing its investigational asset CTx-2103 (buspirone) for the
treatment of anxiety into clinical development.
“Cingulate received input from the FDA regarding the regulatory
pathway for CTx-2103, including filing an Investigational New Drug
(IND) application in the first half of 2024 and the design of
clinical studies,” said Cingulate Chairman and CEO Shane J.
Schaffer. “This is a positive step that may allow CTx-2103 to seek
and win approval under the 505(b)(2) pathway, which typically
requires less time and resources than the 505(b)(1) full NDA
pathway.”
Anxiety disorders are the most common mental health concern in
the U.S.1 An estimated 31 percent of U.S. adults experience an
anxiety disorder at some time in their lives. People may live with
anxiety for years before they are diagnosed or treated.2
CTx-2103, which contains the active pharmaceutical ingredient
buspirone hydrochloride, is a non-benzodiazepine medication that
does not carry the risk of withdrawal or dependency. However, due
to its short half-life, buspirone is prescribed to be taken several
times a day for management of anxiety, which can be challenging for
patients and may lead to sub-optimal treatment outcomes.
CTx-2103 is a once-daily, multi-dose tablet that provides three
precisely timed doses of buspirone versus one immediate release
dose. The Company believes its trimodal tablet will offer clear
differentiation and compelling advantages over currently available
treatment options.
In September 2022, Cingulate completed a formulation study in
which the pharmacokinetics of CTx-2103 were evaluated.
Additionally, scintigraphic imaging visualized transit of the
tablets through the gastrointestinal tract to confirm both the site
and onset of release, which was correlated with the pharmacokinetic
data to establish the release profile of the CTx-2103
formulation.
Based on the data from this study, CTx-2103 provides three timed
releases of buspirone, as it was designed to do.
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 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 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 Relations:Thomas DaltonVice President,
Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301
Matt KrepsDarrow
Associatesmkreps@darrowir.com (214)
597-8200
Media RelationsMelyssa WeibleElixir Health
Public
Relationsmweible@elixirhealthpr.com (201)
723-5805
References:1 National Alliance on Mental
Illness. Anxiety Disorders. Available online. Accessed May
2022.2 Kessler R.C. and P.S. Wang. The Descriptive
Epidemiology of Commonly Occurring Mental Disorders in the United
States*. Annual Review of Public Health. April 2008;
29:115-129.
CING-US-131-1224
Cingulate (NASDAQ:CINGW)
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Cingulate (NASDAQ:CINGW)
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