Cingulate posts clinical data on once-daily, triple-release anxiety tablet

Cingulate has posted pharmacokinetic data from an early-phase clinical trial of its triple-release anxiety drug candidate, providing itself with a platform to support development of a planned once-daily therapy.

Buspirone, the drug molecule in Cingulate’s CTx-2103, is already used to treat anxiety. Because the drug is typically administered two to three times a day, Cingulate sees an opportunity to use its timed release technology to free patients from the need to take multiple doses. Rather, if everything goes to plan, patients will take a single daily dose that will release buspirone at three times throughout the day.

To test whether the idea holds up in the clinic, Cingulate enrolled healthy volunteers to receive either one of three timed-release formulations or an immediate-release buspirone tablet in an open-label study. The study found the triple-release formulation provided 30 mg of buspirone spread across three peaks. 

“Based on the dissolution profile seen in the data, the CTx-2103 30 mg tablet achieved the solubility required to deliver a triple release of buspirone hydrochloride,” Matthew Brams, M.D., chief medical officer of Cingulate, said in a statement. “The tablet was also able to deliver the intended doses at three time points. Based on this data, we’re confident in the ability of CTx-2103 to provide patients with the opportunity for entire-day efficacy, safety, and convenience in a once-daily anxiety medication.”

The release profile was enabled by technology that encases drug molecules in erosion barrier layers. A tablet developed using the technology could feature drug release layers that only become exposed after the erosion of their barriers, enabling Cingulate to stagger when the molecule will enter circulation.

Cingulate has applied the technology to two attention-deficit hyperactivity disorder candidates and the anxiety prospect but has seen investor interest dwindle over the past year, a period in which its share price has fallen 73% to just above $1. The company has enough cash to keep going though the first quarter of 2023.