Cingulate Inc. (NASDAQ: CING), a clinical-stage 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
completion of the formulation study for its third asset, CTx-2103,
for the management of anxiety-related disorders. The study was
conducted at BDD Pharma in the United Kingdom. Results are expected
in August 2022.
CTx-2103 contains the active pharmaceutical
ingredient buspirone hydrochloride, a non-benzodiazepine
medication, which 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.
“We are proud to reach this significant
milestone for our Company and the PTR™ platform as we work
diligently to provide a true once-daily medicine for those with
anxiety-related disorders,” said Shane J. Schaffer, Chairman and
CEO of Cingulate. “Dosing frequency is an important component of
medication adherence in patients and a key contributor to treatment
success or failure. With the PTR™ technology as the foundation of
our pipeline, we strive to make next-generation medicines that
overcome significant unmet medical needs in billion-dollar
markets.”
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
About CTx-2103 and the Formulation
StudyCTx-2103 is a novel, trimodal, extended-release
tablet of buspirone incorporating 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.
The first human subject study of CTx-2103 was a
single-center, open-label, four-arm crossover study in 12 healthy
subjects. Each participant received four different doses of
buspirone at different assessment visits: one timed-release 10mg
tablet releasing drug after a four-hour delay, one timed-release
10mg tablet releasing drug after an eight-hour delay, one
triple-pulse 10mg tablet releasing drug at zero, four and eight
hours, and one immediate release 10mg tablet of generic buspirone
(the reference product, which is a commercially available
formulation).
The primary objective is to evaluate the
absorption of buspirone and the presence of metabolite
1-pyrimidinylpiperazine (1-PP) in blood plasma from time delayed
formulations and correlate with scintigraphic time and site of
release. Secondary objectives of the study will compare the
pharmacokinetic performance of the time delayed buspirone products
with a commercially available formulation. Additionally, the study
will evaluate the absorption of buspirone and the presence of
metabolite 1-PP in blood plasma from a triple-release product.
Safety evaluations demonstrated that CTx-2103 is
safe and well tolerated. No serious, severe, or clinically
meaningful treatment-emergent adverse events (TEAEs) occurred
during this study. Most TEAEs were mild in severity and were
consistent with events expected for buspirone. The evaluation
of TEAEs, laboratory examinations, physical examinations, ECG
recordings, and measurement of vital signs (blood pressure and
pulse rate) revealed no safety concerns for buspirone.
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 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 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 |
Matt KrepsDarrow
Associatesmkreps@darrowir.com214-597-8200 |
|
CING-US-110-0623
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.
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