Cingulate Therapeutics Initiates First Human Clinical Trial
PRNewswire: May 13, 2017 – KANSAS CITY, KS, U.S.A. – Cingulate Therapeutics, LLC, a privately held biopharmaceutical company focused on the development of new and innovative products for the treatment of attention deficit/hyperactivity disorder (ADHD), is proud to announce its transition to a clinical stage development company with the initiation of dosing in its proof of concept trial for CTX-1301, one of two proprietary, first-line stimulant medications the company is developing for the treatment of ADHD. The four-week human clinical trial of CTX-1301 is being conducted in Glasgow, Scotland, by its development partner BioImages Drug Delivery (BDD Pharma).
The randomized, three arm, open-label crossover study is being conducted in healthy volunteers to establish the in vivo pharmacokinetic behavior of CTX-1301 using both gamma scintigraphic imaging and traditional assays to evaluate the body’s absorption, distribution, metabolism, and excretion of CTX-1301. CTX-1301, like its co-lead product CTX-1302, has a target product profile designed to deliver a rapid onset, last the entire active day, and minimize the afternoon crash with minimal impact on sleep and appetite. Both assets utilize proprietary, multi-core timed-release OralogiK™ technology developed by CTx’s partner BDD. Multiple, positive in vitro data sets have demonstrated the desired triphasic controlled-release functionality. The company anticipates reporting findings from this trial in the third quarter of 2017.
Shane J. Schaffer, PharmD, chairman and chief executive officer of Cingulate Therapeutics, said, “The breakthrough multi-core technology employed in CTX-1301 and CTX-1302 combines layers of immediate, delayed, and sustained release medication in a single tablet intended to deliver the appropriate dose and at the right time when ADHD patients need it. This study intends to demonstrate the ability of our technology to achieve the target product profiles in advance of filing separate IND applications with the U.S. Food and Drug Administration by the end of this year.”
Both assets utilize the innovative, proprietary timed-release technology OralogiK developed by CTx’s partner BDD. Dr. Carol Thomson, CEO of BDD, said, “We are delighted to be working with Cingulate Therapeutics to develop this exciting new product which is now undergoing clinical evaluation using our pharmaco-scintigraphic capabilities. The OralogiK technology is uniquely positioned to deliver the triphasic release profile required of the CTX-1301 and CTX-1302 products.”
Cingulate Therapeutics, LLC, is a privately held clinical-stage biopharmaceutical company focused on the development of new and innovative products for the treatment of attention deficit/hyperactivity disorder (ADHD). Cingulate is developing two proprietary, first-line medications, CTX-1301 and CTX-1302, 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, last the entire active day, and minimize the afternoon crash with minimal impact on sleep and appetite. The company has initiated proof of concept phase I clinical trials and plans to implement the full clinical plan for both CTX-1301 and CTX-1302 in early 2018. Cingulate anticipates filing INDs for CTX-1301 and CTX-1302 via the accelerated 505 (b) (2) regulatory pathway. The company has offices in Kansas City, Kansas, and Morristown, New Jersey. For more information, visit www.cingulatetherapeutics.com.
Bio-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 triphasic release of one or multiple drugs. The OralogiK™ technology is protected with granted patents in the United States, European Union, 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.
