Cingulate Therapeutics has reported positive results from its first in-human proof-of-concept trial of CTX-1301 in comparison with Focalin XR for the treatment of attention deficit hyperactivity disorder (ADHD).

The trial was designed to assess the pharmacokinetics and delivery mechanism of CTX-1301, using a new erosion barrier technology, OralogiK, which is developed by the UK-based company’s Bio-Images Drug Delivery (BDD).

It comprises three treatment arms including Focalin XR, CTX-1301 with a radiolabelled second layer, and CTX-1301 with a radiolabelled third layer.

During the trial, pharmacoscintigraphy monitored transit of the radiolabelled tablets through the gastrointestinal tract.

The trial also showed a mean time of 10.3 hours to the final release of CTX-1301, providing a statistically significant difference between the mean AUC eight to 24 hours post-dosing of the two CTX-1301 treatment groups and that of Focalin XR (17.05ng-hr/mL).

Improvement in the mean time has also confirmed higher blood plasma drug levels with CTX-1301 versus Focalin XR.

“We’ve been able to gain valuable insight as to how our assets are expected to perform in-vivo.”

During the study, CTX-1301 also offered a smoother, controlled descent of dexmethylphenidate hydrochloride (d-MPH) after the final dose as compared to Focalin XR.

Overall, the study showed that CTX-1301 delivered a consistent tri-modal release of the d-MPH and extended its blood plasma levels by four hours when compared with Focalin XR’s bi-phasic release of d-MPH.

Cingulate Therapeutics chairman and CEO Shane Schaffer said: “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.”

Cingulate further will implement a full clinical plan for CTX-1301, a stimulant medication for the treatment of ADHD within this year.