Cingulate Begins Final Study for Lead ADHD Drug CTx-1301

On September 12, 2024, Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company leveraging its proprietary Precision Timed Release™ (PTR™) drug delivery platform, announced the commencement of its final FDA-required study for CTx-1301 (dexmethylphenidate), aimed at treating Attention Deficit Hyperactivity Disorder (ADHD). The study, assessing the impact of food on the absorption of the highest dose of CTx-1301, is expected to yield data by the end of 2024.

Cingulate has successfully raised over $10 million in additional capital since mid-August 2024, with 58% of this amount coming from its market facility. The company also received notification from Nasdaq confirming compliance with Nasdaq listing requirements.

Shane J. Schaffer, Chairman and CEO of Cingulate, expressed satisfaction with the capital raised, stating it allows the company to focus on advancing final activities necessary for the NDA submission of CTx-1301, targeted for mid-2025. Schaffer highlighted that the initiation of the final study for CTx-1301 marks a significant milestone towards NDA submission.

This final study is an open-label, randomized, single-dose, two-period, two-treatment (Fed vs. Fasted), two-sequence, crossover study involving healthy adult subjects. It aims to evaluate how food affects the bioavailability of the highest dose of CTx-1301 (dexmethylphenidate).

ADHD is a chronic neurobiological and developmental disorder impacting millions of children, often continuing into adulthood. Characterized by persistent patterns of inattention and/or hyperactivity-impulsivity, ADHD significantly interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents under 18 have been diagnosed with ADHD, with around 80% receiving treatment. Among those treated, 65-90% exhibit clinical symptoms that persist into adulthood. The adult ADHD patient population is estimated at around 11 million, but only about 20% receive treatment.

Cingulate’s lead candidate, CTx-1301, utilizes the company’s proprietary PTR platform to create a multi-core formulation of dexmethylphenidate, a stimulant approved by the FDA for ADHD treatment. Dexmethylphenidate increases norepinephrine and dopamine activity in the brain, impacting attention and behavior. Stimulants are considered the gold standard for ADHD treatment due to their efficacy and safety. However, the challenge remains to provide an entire active-day duration of action. CTx-1301 is designed to deliver three timed releases of medication in one tablet, offering rapid onset and full-day efficacy, with the final dose releasing when other extended-release stimulants begin to wear off.

Cingulate is also developing product candidates for ADHD and anxiety disorders using its innovative PTR platform. This technology incorporates a proprietary Erosion Barrier Layer (EBL) to control drug release at precise times, ensuring no premature drug release. The EBL technology, enrobed around a drug-containing core, forms a tablet-in-tablet dose designed to erode at a controlled rate until drug release. The EBL formulation, Oralogik™, is licensed from BDD Pharma. Cingulate plans to use its PTR technology to expand its clinical-stage pipeline by developing additional candidates in other therapeutic areas that require specific, timed drug delivery for significant treatment improvement.

Cingulate Inc. (NASDAQ: CING) is headquartered in Kansas City and focuses on leveraging its PTR platform to develop next-generation pharmaceutical products that improve patient outcomes for conditions requiring frequent daily dosing and suboptimal treatments. The company is currently focused on ADHD treatment but is also exploring other therapeutic areas, including anxiety disorders.

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