KANSAS CITY, Kan., Nov. 15, 2017 /PRNewswire/ -- Cingulate Therapeutics, LLC, a clinical stage biopharmaceutical company
The study evaluated CTX-1301, Cingulate's proprietary, first-line stimulant medication for the treatment of Attention Deficit – Hyperactivity Disorder (ADHD), utilizing an innovative, proprietary timed release technology OralogiK™ developed by CTx's partner BDD. Researchers found that the dexmethylphenidate hydrochloride (d-MPH) in CTX-1301 delivered consistent tri-modal release profiles and extended d-MPH blood plasma levels by 4-6 hours when compared to Focalin XR®.
Steve Abele, Vice President of Manufacturing & Development for Cingulate Therapeutics, said, "The proof of concept clinical data corroborates our predictive models describing the relationship between the in vitro properties of CTX-1301's dosage form and the relevant desired in vivo target product profile response. This data demonstrates the precision and accuracy of the platform technology enabling the release timing of the multiple doses of drug, to enable a rapid onset, coverage over the entire active day and a controlled decline of blood plasma levels."
Shane J. Schaffer, PharmD, Chairman and Chief Executive Officer of Cingulate Therapeutics, said, "We are very pleased with this first-in-human data, which validates the drug delivery platform technology. In the near term, we have submitted two pre-IND packages to the Food and Drug Administration and look forward to the initiation of our Phase 1/2 clinical trials in 2018. We believe this data indicates that CTX-1301 and CTX-1302 have the potential to become true once-daily timed release ADHD medications, enhancing patient outcomes and earning a significant share of the $12 billion ADHD market."
The study contained three treatment arms: (1) commercially available Focalin® XR 10.0-mg, (2) CTX-1301 12.5-mg with a radiolabeled second layer, and (3) CTX-1301 12.5-mg with a radiolabeled third layer. Plasma drug levels were measured in all three arms to determine pharmacokinetic parameters. Pharmacoscintigraphy monitored gastrointestinal tract transit times and drug release site of the radiolabeled tablets (arms 2 & 3). Mean time to inner core release of CTX-1301 was eight to ten hours post-ingestion, with mean AUC8-24 hours post-dosing of the two CTX-1301 treatment groups both greater than that of Focalin® XR, confirming higher blood plasma drug levels with CTX-1301 versus Focalin® XR later in the day.
About Cingulate TherapeuticsCingulate Therapeutics, LLC is a privately held clinical stage biopharmaceutical company focused on the development of new and innovative products utilizing the Company's innovative 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 minimizing the afternoon crash and impact on sleep and appetite. 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 early 2018. Cingulate anticipates filing INDs for both products in the first 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.
About BDDBio-images Drug Delivery Ltd (BDD) 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, sustained 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 US, EU and Japan. BDD has in house clinical trial capabilities for conduct of gamma scintigraphic/ pharmacokinetic studies in men. For more information visit www.bddpharma.com.
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SOURCE Cingulate Therapeutics, LLC
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