Cingulate Therapeutics said today that it landed a $7.5 million investment to help fund the development of its controlled-release ADHD drugs.
The Kansas City-based company is working on a set of therapies that utilize its ‘Precision Time Release’ drug-delivery platform. Cingulate’s CEO, Shane Schaffer, told Drug Delivery Business News that his company set out to create an ADHD therapy that tackles all of the challenges posed by existing therapies.
“One of the key aspects is that you’re trying to serve two masters a lot of the time in ADHD – you want to have a very fast onset of action, but at the same time, you want to have a very extended duration of action,” he said.
The company’s lead product candidates, CTx-1301 and CTx-1302, are designed to begin working in less than 30 minutes after administration, persist for 14-16 hours and give a controlled descent of plasma drug levels, according to Schaffer.
“We’re looking at getting these drugs on the market in less than 36 months; hopefully, even sooner,” he said.
Cingulate’s Precision Time Release drug-delivery technology makes use of a “Russian doll”-like effect, Schaffer explained – in a single tablet, Cingulate can combine layers of immediate- and sustained-release pharmaceuticals to better control the product’s overall pharmacokinetic profile.
In January, the company touted data from its first proof-of-concept study of CTX-1301. The trial included three treatment arms – one group was given Novartis‘ (NYSE:NVS) Focalin XR, another group was given CTX-1301 with a radiolabeled second layer and a third group was given CTX-1301 with a radiolabeled third layer. The radiolabeled tablets were monitored as they traveled through a person’s GI tract to track delivery.
Cingulate reported that it observed consistent, tri-modal release of its dexmethylphenidate hydrochloride product and that CTX-1301 extended blood plasma drug levels by four hours compared to Focalin XR.
Looking ahead, Schaffer expects to move quickly through the clinical development process.
“Our goal is to create ideal ADHD medications and at the same time, benefit the health care system,” he said. “We feel that we can provide much more cost-effective agents, which will benefit patients and payers, as well as physicians, giving them a single daily option for treatment and [Precision Time Release] does that.”
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