Cingulate Therapeutics Presents Results of Pivotal Phase 2 Clinical Trial for Lead ADHD Candidate CTx-1301 at the American Association of Child and Adolescent Psychiatry Annual Meeting

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Data Demonstrates Extended Duration, Fast Onset of Action, and the Potential for Elimination of Booster Doses

KANSAS CITY, Kan., Oct. 26, 2020 /PRNewswire/ -- Cingulate Therapeutics, a privately-held, clinical-stage, biopharmaceutical company focused on the development of innovative new products for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD), today announced results from the Company's Phase 1/2, randomized, single-dose, four-sequence, four-period, in-clinic crossover study in adult ADHD patients to establish safety, tolerability, comparative bioavailability, and dose proportionality of CTx-1301 versus Focalin® XR. These results demonstrated the comparative bioavailability (bridging) between these two products, confirming the 505(b)(2) pathway. No serious adverse events were reported in the study. The data was presented at the American Association of Child and Adolescent Psychiatry (AACAP) annual virtual meeting October 12-24, 2020. Cingulate plans to conduct Phase 3 trials in 2021.

"The data is impressive and will help position Cingulate's CTx-1301 product to achieve rapid market uptake," said Shane J. Schaffer, PharmD, Chairman and CEO of Cingulate Therapeutics. "The data in our study not only achieved bridging to the listed drug, but also indicated critical differentiators from any other product available in the ADHD market."

Matthew Brams, MD, Chief Medical Officer at Cingulate, remarked, "The data from this Pivotal Trial provided another confirmation that Cingulate has developed an ADHD medication that will substantially improve the lives of patients by overcoming longstanding unmet medical needs. Our Phase 3 trials are designed to further confirm the pharmacokinetic-pharmacodynamic relationship of stimulants for ADHD. CTx-1301 has the potential to be the only product for ADHD with a 30-minute onset of action, efficacy that lasts the 'entire active day', and a controlled descent of drug levels with the potential to minimize or prevent the afternoon wear-off effects, or 'crash'; And from a societal perspective, CTx-1301, with its built-in booster may eliminate the need for a 'booster' or 'recovery' dose required by millions of ADHD patients and could reduce the abuse and diversion of these short-acting stimulants."

About Cingulate Therapeutics
Cingulate Therapeutics, LLC is a privately-held, clinical-stage, biopharmaceutical company focused on the development of new and innovative products utilizing the Company's disruptive, proprietary Precision Timed Release™ (PTR™) drug delivery platform technology that enables the creation of a true once-daily, multi-dose tablet. Cingulate's two lead assets in the $18B ADHD market include CTx-1301 (dexmethylphenidate) and CTx-1302 (dextroamphetamine) –both first-line treatments – intended for all patient segments: children, adolescents, and adults. CTx-1301 and CTx-1302 utilize an innovative, flexible-core, tableting technology with a Target Product Profile designed to deliver a rapid onset and last the entire active day while providing a controlled descent of plasma drug levels to optimize treatment. The Company will pursue approval via the accelerated 505(b)(2) regulatory pathway.

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Caution Concerning Forward Looking Statements

This press release may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements include all statements that do not relate solely to historical or current facts, including without limitation the Company's proposed development and commercial timelines, and can be identified by the use of words such as "may," "will," "expect," "project," "estimate," "anticipate," "plan," "believe," "potential," "possibly," "should," "could," "continue" or the negative versions of those words or other comparable words. Forward-looking statements are not guarantees of future actions or performance. These forward-looking statements, including the timing and probability of potential FDA approval of the CTx-1301 NDA, and the potential commercial launch of CTx-1301. The potential clinical benefits of CTx-1301 or any of Cingulate Therapeutics product candidates are based on information currently available to Cingulate Therapeutics and its current plans or expectations and are subject to a number of uncertainties and risks that could significantly affect current plans. Cingulate Therapeutics is under no obligation to, and expressly disclaims any such obligation to, update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.


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SOURCE Cingulate Therapeutics LLC