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Cingulate Receives Guidance from FDA on Path Forward for Anxiety Asset CTx-2103 (buspirone)

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Cingulate Inc. (NASDAQ: CING) has received guidance from the FDA to advance its investigational asset CTx-2103 for the treatment of anxiety into clinical development. The company plans to file an IND application in the first half of 2024 and design clinical studies for CTx-2103. This step may allow CTx-2103 to seek approval under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway. CTx-2103 is a once-daily, multi-dose tablet that provides three precisely timed doses of buspirone versus one immediate release dose, offering clear differentiation and compelling advantages over currently available treatment options.
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KANSAS CITY, Kan., Dec. 01, 2023 (GLOBE NEWSWIRE) -- 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 Anxiety
Anxiety 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
Cingulate 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 Dalton
Vice President, Investor & Public Relations, Cingulate
tdalton@cingulate.com
(913) 942-2301

Matt Kreps
Darrow Associates
mkreps@darrowir.com 
(214) 597-8200

Media Relations
Melyssa Weible
Elixir Health Public Relations
mweible@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 Inc. (NASDAQ: CING) has received guidance from the FDA to advance its investigational asset CTx-2103 for the treatment of anxiety into clinical development.

CTx-2103 may seek approval under the 505(b)(2) pathway, which typically requires less time and resources than the 505(b)(1) full NDA pathway.

CTx-2103 is a once-daily, multi-dose tablet that provides three precisely timed doses of buspirone versus one immediate release dose, offering clear differentiation and compelling advantages over currently available treatment options.

Cingulate Inc. plans to file an IND application in the first half of 2024.

CTx-2103 contains the active pharmaceutical ingredient buspirone hydrochloride, a non-benzodiazepine medication that does not carry the risk of withdrawal or dependency.

Buspirone in CTx-2103 is a non-benzodiazepine medication that does not carry the risk of withdrawal or dependency.

CTx-2103 provides three precisely timed releases of buspirone, offering 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, and 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.
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