Cingulate Announces Complete Enrollment in Human Formulation Study of CTx-2103 for the Treatment of Anxiety Disorders Using OralogiK™

Active Pharmaceutical Ingredient – Buspirone – One of the Most Widely Prescribed Agents in $5.5B U.S. Anxiety Market, Which Must be Taken Multiple Times Daily

CTx-2103 is the Third Candidate Using Cingulate’s Proprietary Precision Timed Release™ Drug Delivery Platform Technology for Once-daily Dosing Via Three Precise, Pre-defined Drug Releases

KANSAS CITY, Kan., May 24, 2022 (GLOBE NEWSWIRE) — 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 Study
CTx-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 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. 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.

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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.