Cingulate Secures European Patent for ADHD Drug CTx-1301

Aug. 15, 2024 -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company known for its innovative Precision Timed Release™ (PTR™) drug delivery platform, has secured a new European patent for its primary product, CTx-1301 (dexmethylphenidate), aimed at treating Attention Deficit Hyperactivity Disorder (ADHD).

The patent, granted on August 14, 2024, under EP Patent No. 3261625, covers up to 30 European territories, including the United Kingdom. This addition complements Cingulate's existing patents in Australia, Canada, and Israel, as well as pending applications in Hong Kong, South Korea, and the United States.

Shane J. Schaffer, Chairman and CEO of Cingulate, stated, "The approval of this patent marks a significant step forward as Cingulate extends its influence beyond the U.S. and enters the expanding ADHD markets in Europe and other international territories. We anticipate securing additional patents soon as we continue to demonstrate the clinical efficacy of CTx-1301 and prepare for a new drug application submission to the FDA."

ADHD is a chronic neurodevelopmental disorder impacting millions of children and frequently persisting into adulthood. It is characterized by persistent patterns of inattention and/or hyperactivity-impulsivity, which disrupt functioning or development. In the United States, about 6.4 million children and adolescents under 18 (approximately 11 percent) are diagnosed with ADHD. Among them, around 80 percent receive treatment, and 65-90 percent continue to exhibit clinical ADHD symptoms into adulthood. Adult ADHD affects an estimated 11 million individuals (4.4 percent), nearly double the number of children and adolescents combined, although only about 20 percent receive treatment.

Cingulate’s leading candidate, CTx-1301, leverages the company's proprietary PTR platform to develop a groundbreaking multi-core formulation of dexmethylphenidate. Dexmethylphenidate, an FDA-approved stimulant, enhances norepinephrine and dopamine activity in the brain, influencing attention and behavior. Stimulants are the preferred treatment for ADHD due to their effectiveness and safety, although providing a full active-day duration remains a challenge. CTx-1301 is engineered to deliver three precise medication releases in one tablet, ensuring rapid onset and prolonged efficacy throughout the day, with the third dose kicking in as other extended-release stimulants begin to wear off.

Cingulate is also exploring the development of products for ADHD and anxiety disorders that can achieve true once-daily dosing using its PTR platform. This technology includes a proprietary Erosion Barrier Layer (EBL) that controls drug release at predetermined times without prior release. The EBL technology involves a drug-containing core within a tablet-in-tablet form. The layer erodes at a controlled rate, eventually releasing the drug from the core tablet. The EBL formulation, known as Oralogik™, is licensed from BDD Pharma. Cingulate plans to use this PTR technology to expand its clinical-stage pipeline, identifying and developing new candidates in other therapeutic areas besides ADHD and anxiety, where multiple daily doses of pharmaceutical ingredients are required at specific, predefined intervals to improve existing treatments.

Cingulate Inc. is dedicated to utilizing its PTR technology platform to create next-generation pharmaceutical products aimed at enhancing the lives of patients suffering from conditions that require frequent daily dosing and often result in suboptimal treatment outcomes. Initially focusing on ADHD, Cingulate is also exploring other therapeutic areas for future product development, including treatments for anxiety disorders.