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, today announced findings
from its formulation study for CTx-2103, the Company’s asset for
the management of anxiety-related disorders. The data was featured
in a poster presentation at the 2022 Psych Congress meeting, taking
place September 17-20 in New Orleans, LA.
“The readout of the data is a crucial step in
our quest to bring the best-possible, once-daily formulation of
buspirone to patients,” said Shane J. Schaffer, Chairman and
CEO of Cingulate. “Formulation development is the key component in
how we approach building next-generation medicines aimed at
changing the paradigm of oral drug delivery. These results provide
critical information as we move forward to designing our clinical
program for anxiety.”
In the study, the pharmacokinetics were
evaluated for three multi-layered, timed-release oral tablets and
one immediate release dose of buspirone. Scintigraphic imaging
visualized transit of the tablets through the gastrointestinal
tract to confirm both the site and onset of release, which will
then be correlated with pharmacokinetic data to establish the full
release profile of the CTx-2103 formulation.
“Based on the dissolution profile seen in the
data, the CTx-2103 30 mg tablet achieved the solubility required to
deliver a triple release of buspirone hydrochloride,” said Matthew
Brams, M.D., Chief Medical Officer and a Co-Founder of Cingulate.
“The tablet was also able to deliver the intended doses at three
time points. Based on this data, we’re confident in the ability of
CTx-2103 to provide patients with the opportunity for entire-day
efficacy, safety, and convenience in a once-daily anxiety
medication.”
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, a
non-benzodiazepine medication, has no evidence for the development
or risk of 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 will be
designed as a once-daily, multi-dose tablet, which the Company
believes will offer clear differentiation and compelling advantages
over currently available treatment options.
About CTx-2103 CTx-2103 is a
novel, trimodal, extended-release tablet of buspirone being
developed to incorporate the Cingulate’s proprietary PTR™ drug
delivery platform, and 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 Technology and OralogiK™ Cingulate is developing
ADHD and anxiety disorder product candidates capable of achieving
true once-daily dosing using the Company’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 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.
For more information visit
Cingulate.com/technology.
About Cingulate®Cingulate Inc.
(NASDAQ: CING), is a clinical-stage 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 neurological disorders, 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 28, 2022. 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.
Contacts: |
|
Investor
Relations Thomas Dalton Head of Investor & Public
Relations, CingulateTDalton@cingulate.com913-942-2301 |
Media RelationsMelyssa WeibleElixir Health Public
Relationsmweible@elixirhealthpr.com201-723-5805 |
CING-US-114-0919
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.
Cingulate (NASDAQ:CING)
Historical Stock Chart
From Jun 2024 to Jul 2024
Cingulate (NASDAQ:CING)
Historical Stock Chart
From Jul 2023 to Jul 2024