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 the
Company has completed enrollment in its study to determine the
appropriate formulation of its third asset, CTx-2103, for the
management of anxiety-related disorders. This study was initiated
in May 2022 with 12 enrollees. Results of the study are expected in
July 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 feel Cingulate’s Precision Timed Release™
drug delivery platform will allow us to design a single
administration buspirone product that provides clinicians the
ability to optimize treatment over the full course of the day,”
said Shane J. Schaffer, Chairman and Chief Executive Officer,
Cingulate. “CTx-2103 represents the initial expansion of our
clinical-stage pipeline into new therapeutic areas, which also
includes two candidates for attention deficit/hyperactivity
disorder (ADHD). This illustrates how our PTR™ platform technology
can be applied to other therapeutic areas where current
standard-of-care treatments require dosing several times a day, and
in which a consistent, single-dose formulation may offer
significant improvements for patients.”
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
“Our PTR™ technology has uniquely positioned us
to create next-generation products that change the paradigm of oral
drug delivery by combining multiple doses of drug into a single
tablet,” said Matthew Brams, M.D., Chief Medical Officer,
Cingulate. “Nonadherence, which is a common issue with current
anxiety medications, leads to suboptimal treatment outcomes for all
stakeholders. CTx-2103 has the potential to be beneficial for
patients, payors, and providers, and can be applied to markets
beyond ADHD and anxiety, where once-daily dosing could make an
important contribution to optimizing treatment.”
Cingulate’s innovative PTR™ platform
incorporates a proprietary Erosion Barrier Layer (EBL) that
provides 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.
“We are delighted to be partnering again with
the Cingulate team to extend their pipeline of triple pulse
products using BDD’s modified-release technology, OralogiK,” said
Carol Thomson, Chief Executive Officer, BDD Pharma. “CTx-2103
offers once-daily dosing and will be an exciting addition to the
CNS market. This clinical formulation study utilizes our SWIFT
adaptive clinical trial platform to deliver rapid results and is
the first significant step towards an accelerated route to
market.”
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, is 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 is a
single-center, open-label, four-arm crossover study in 12 healthy
subjects. Each participant will receive 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 (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.
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. According to the American
Psychiatric Association, anxiety can be categorized into
phobias, acute stress disorder, panic disorder,
obsessive-compulsive disorder, generalized anxiety disorder, and
post-traumatic stress disorder. 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 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 wrapped around a drug-containing core to give a
tablet-in-tablet dose form.
Cingulate intends to utilize its PTR™ technology
to expand and augment its clinical-stage pipeline by identifying
and developing additional product candidates in other CNS
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
About BDD®BDD Pharma Ltd is a
privately-owned drug delivery company specializing in the
development of modified and controlled release oral formulations.
BDD’s OralogiK™ technology is a tablet-in-tablet drug delivery
system providing timed release, targeted release, and the
opportunity for complex bi- and tri-phasic release of one or
multiple drugs. The OralogiK™ technology is protected with granted
patents in the U.S., EU, and Japan. Supported by investment from
Archangels and the Scottish Investment Bank, BDD has in-house
clinical trial capabilities for the conduct of gamma
scintigraphic/pharmacokinetic studies in humans.
BDD’s SWIFT adaptive clinical trials integrate
formulation development, GMP manufacturing and clinical testing
into one streamlined service, offering a more flexible approach
than the conventional clinical trial design structure.
For more information visit
www.bddpharma.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-108-0253
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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