Cingulate Therapeutics Presents New Data from its First in Human Proof of Concept Trial of CTX-1301 at the 2018 APSARD Annual Meeting

Cingulate Therapeutics Presents New Data from its First in Human Proof of Concept Trial of CTX-1301 at the 2018 APSARD Annual Meeting

Kansas City, KS – (January 15, 2018) – Cingulate Therapeutics LLC a clinical stage biopharmaceutical company focused on the development of new and innovative products utilizing its precision timed release drug delivery platform technology, today announced the presentation of a poster titled, “Pharmacoscintigraphic and Pharmacokinetic Analysis of CTx-1301, a Novel Tri-modal Oral Formulation for Release of Dexmethylphenidate in Healthy Adults” at the 2018 American Professional Society of ADHD and Related Disorders (APSARD) Annual Meeting held from January 12-14, 2018 in Washington D.C. The poster marked the final release of data from a study evaluating the pharmacokinetics and delivery mechanism of CTX-1301, Cingulate Therapeutics’ proprietary, first-line stimulant medication for the treatment of Attention Deficit – Hyperactivity Disorder (ADHD), utilizing an innovative, proprietary erosion barrier technology, OralogiK™ developed by Cingulate Therapeutics partner Bio-Images Drug Delivery (BDD) of Glasgow Scotland, UK.

The study contained three treatment arms: (1) Focalin® XR, (2) CTX-1301 with radiolabeled second layer, and (3) CTX-1301 with radiolabeled third layer. Pharmacoscintigraphy monitored transit of the radiolabeled tablets through the gastrointestinal tract.   Importantly, mean time to the final release of CTX-1301 was 10.3 hours, with a statistically significant difference (p<0.005) between the mean AUC 8-24 hours post-dosing of the two CTX-1301 treatment groups (29.24 & 31.60 ng-hr/mL, respectively) versus that of Focalin XR (17.05 ng-hr/mL), confirming higher blood plasma drug levels with CTX-1301 versus Focalin XR. CTX-1301 also provided a smoother, controlled descent of d-MPH after the final dose as compared to Focalin XR.

Overall, researchers found that CTX-1301 delivered consistent tri-modal release of the dexmethylphenidate hydrochloride (d-MPH), and extended d-MPH blood plasma levels by 4 hours when compared to Focalin® XR’s bi-phasic release of d-MPH.

Shane J. Schaffer, PharmD, Chairman and Chief Executive Officer of Cingulate Therapeutics, said, “These results are a major accomplishment. Before Cingulate Therapeutics embarks on the studies necessary to gain FDA approval, we’ve been able to gain valuable insight as to how our assets are expected to perform in vivo.  We are now preparing our Investigational New Drug (IND) filings for our lead ADHD products even as these results indicate the ability of our platform to deliver precisely timed doses for a wide range of therapeutic agents.”

Raul R. Silva, MD, Co-Founder and Chief Scientific Officer of Cingulate Therapeutics said, “Stimulants are the most commonly prescribed class of medications for the treatment of ADHD now and for the foreseeable future. While research and clinical outcomes have supported their continued use, there has not yet been a single product developed that can deliver a Target Product Profile fulfilling all of the ADHD patient’s needs in a single dose. Cingulate Therapeutics believes that these results indicate that our Precision Timed Release™ (PTR™) technology may enable CTX-1301 and CTX-1302 to provide the desired product profile, which has the potential for better patient outcomes and quality of life. In the meantime, future investigations will include simulated classroom and workplace studies to link the pharmacokinetics and clinical efficacy of both of our investigational agents.”


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 innovative, precision timed release drug delivery platform technology that enables the formulation and manufacture of once-daily tablets of multi-dose therapies, with an initial focus on for the treatment of Attention Deficit/Hyperactivity Disorder (ADHD). Cingulate is developing two proprietary, first-line stimulant medications, CTX-1301 (dexmethylphenidate) and CTX-1302 (dextroamphetamine), for the treatment of ADHD 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 has completed a Proof of Concept Phase I clinical trial and plans to implement the full clinical plan for both CTX-1301 and CTX-1302 in 2018. Cingulate anticipates filing IND’s for both assets in the second quarter of 2018 and will pursue approval via the accelerated 505(b)(2) regulatory pathway. The company has offices in Kansas City, KS and Morristown, NJ. For more information visit www.cingulatetherapeutics.com.

 

For Investors & Media:
Tiberend Strategic Advisors, Inc. on behalf of Cingulate Therapeutics
Jonathon Brzezinski, Ph.D.: jbrzezinski@tiberend.com; (212) 375-2681
Janine McCargo: jmccargo@tiberend.com; (646) 604-5150