Cingulate Strides Towards Delivery of All-Day ADHD Therapeutic

Biopharmaceutical company, Cingulate (Nasdaq: CING) has announced positive topline results in its fed/fast study of CTx-1301, demonstrating the drug can be taken with or without food.

CTx-1301 is poised to deliver the first once-daily treatment for attention-deficit hyperactivity disorder (ADHD), a neurodevelopmental condition affecting approximately 6.4 million children and 11 million adults in the United States.

Highlights

• Cingulate’s trial demonstrated that CTx-1301 can be taken with or without food, and that food did not delay absorption and should not affect onset of action.
• The company initiated its first Phase 3 trial for CTx-1301 which will be an adult dose-optimization safety and efficacy study. Results are expected in Q3 2023.
• Cingulate expects to initiate a pivotal Phase 3 trial in mid-2023. The study will be a fixed-dose, placebo-controlled trial in pediatric and adolescent patients.
• CTx-1301 is a novel, investigational, trimodal, extended-release tablet formation of dexmethylphenidate. Dexmethylphenidate is approved by the FDA for use in the treatment of ADHD.

Cingulate’s lead candidate utilizes the company’s proprietary Precision Timed Release (PTR) drug delivery platform to deliver three releases of medication at a predefined time during the day, in one capsule. It incorporates an Erosion Barrier Layer (EBL) designed to erode at a controlled rate, which enables tablet-in-tablet dosing.