Cingulate Announces Completion of CTx-2103 Human Formulation Study for the Treatment of Anxiety Disorders

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Cingulate Inc.

CTx-2103 (buspirone) is the third candidate using Cingulate’s proprietary Precision Timed Release™ drug delivery platform technology for once-daily dosing via three precise, pre-set drug releases

KANSAS CITY, Kan., June 23, 2022 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a clinical-stage biopharmaceutical company using its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to develop and advancing a pipeline of next-generation pharmaceuticals, today announced the completion of the formulation study of its third asset, CTx-2103, for the management of anxiety-related disorders. The study was conducted at BDD Pharma in the UK. The results are expected in August 2022.

CTx-2103 contains the active pharmaceutical ingredient buspirone hydrochloride, a non-benzodiazepine drug, which has no evidence of development or risk of addiction. However, due to its short half-life, buspirone is prescribed to be taken several times a day for anxiety management, which can be difficult for patients and can lead to suboptimal treatment results. CTx-2103 will be designed as a once-daily, multi-dose tablet, which the company says will provide clear differentiation and compelling benefits over currently available treatment options.

“We are proud to have achieved this important milestone for our company and the PTR™ platform as we work diligently to deliver true, once-daily medicine to people with anxiety-related disorders,” said Shane J. Schaffer, Chairman and CEO of Cingulate. “Dosing frequency is an important element of patient compliance and a key factor in treatment success or failure. With PTR™ technology as the foundation of our pipeline, we strive to manufacture next-generation medicines that overcome significant unmet medical needs in billion-dollar markets.

Anxiety disorders are the most common mental health problem in the United States1 It is estimated that 31% of American adults suffer from an anxiety disorder at some point in their lives. People can live with anxiety for years before being diagnosed or treated.2

About CTx-2103 and the Formulation Study
CTx-2103 is a novel trimodal sustained-release buspirone tablet incorporating Cingulate’s proprietary PTR™ drug delivery platform, and is being investigated for the treatment of anxiety and/or anxiety-related disorders . Buspirone, an azapirone derivative and partial 5-HT1A agonist, was the first non-benzodiazepine anxiolytic introduced for the treatment of generalized anxiety disorder. Buspirone may have a reduced side effect profile compared to other anti-anxiety treatments. Unlike benzodiazepines and barbiturates, there is no associated risk of physical dependence or withdrawal with the use of buspirone due to the lack of effects on gamma-aminobutyric acid receptors.

The first human 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: a 10 mg extended-release tablet releasing the drug after a four-hour delay, a 10 mg extended-release tablet releasing the drug after a eight hours, a 10 mg triple pulse tablet releasing drug at zero, four and eight hours, and a 10 mg immediate release tablet of generic buspirone (the reference product, which is a commercially available formulation).

The main objective is to evaluate the absorption of buspirone and the presence of the metabolite 1-pyrimidinylpiperazine (1-PP) in the blood plasma from delayed formulations and to correlate them with the scintigraphic time and the release site. The secondary objectives of the study will compare the pharmacokinetic performance of delayed release buspirone products with a commercially available formulation. In addition, the study will assess the absorption of buspirone and the presence of the 1-PP metabolite in the blood plasma of a triple release product.

Safety evaluations have demonstrated that CTx-2103 is safe and well tolerated. No severe, serious, or clinically significant treatment-related adverse events (TEAEs) occurred during this study. Most of the TEAEs were mild in severity and consistent with events expected for buspirone. Evaluation of TEAEs, laboratory tests, physical exams, ECG recordings, and measurement of vital signs (blood pressure and pulse) revealed no safety concerns for buspirone.

About anxiety
Anxiety disorders are the most common mental health problem in the United States1 Anxiety is the feeling of fear that arises in the face of threatening or stressful situations or that can be endogenous and not have an identified stressor. It may be a normal response to danger, but if it is severe and chronic and affects functioning, it may be considered an anxiety disorder. It is estimated that 31% of American adults suffer from an anxiety disorder at some point in their lives.2 People can live with anxiety for years before being diagnosed or treated. The global COVID-19 crisis has exacerbated the diagnosis and treatment of anxiety and anxiety-related disorders and, therefore, is a priority in the category of unmet medical needs in mental health.

About Precision Timed Release™ (PTR™) and OralogiK™ Platform Technology
Cingulate is developing product candidates for ADHD and anxiety disorders capable of delivering a true once-a-day dose using the company’s innovative PTR™ drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) to control drug release at specific, pre-defined times without drug release prior to scheduled release. EBL technology is wrapped around a drug-containing core to give a tablet-in-tablet dosage form. It is designed to erode at a controlled rate until the drug is finally released from the tablet core. The EBL formulation, Oralogik™, is licensed from BDD Pharma.

Cingulate intends to use 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 must be administered multiple times per day. at specific, pre-set time intervals and released in a way 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 that uses its proprietary PTR™ drug delivery platform technology to create and advance a portfolio of next-generation pharmaceutical products designed to improve the lives of patients with commonly diagnosed diseases. characterized by heavy 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 could be used 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 facts, regarding our current opinions and assumptions regarding future events affecting our business, including statements regarding our plans, assumptions, expectations, beliefs and goals with respect to product development , clinical studies, clinical and regulatory timelines, market opportunities, competitive position, business strategies, potential growth opportunities and other statements of a predictive nature.

These statements are generally identified by the use of words such as “may”, “could”, “should”, “will”, “believe”, “anticipate”, “plan”, “estimate”, “expect”. “, “to the intention of”. ”, “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 due to 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 they are made, and we undertake no obligation 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.

CING-US-110-0623

References:
1 National Alliance on Mental Illness. Anxiety disorders. Available online. Accessed May 2022.
2 Kessler RC and PS Wang. The descriptive epidemiology of common mental disorders in the United States*. Annual Public Health Review. April 2008; 29:115-129.

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