Cingulate Inc., a biopharmaceutical company utilizing its Precision Timed Release (PTR) drug delivery platform technology to advance a pipeline of next-generation pharmaceuticals, announced the successful completion of the manufacturing transfer of its lead candidate, CTx-1301 (dexmethylphenidate), to Societal CDMO, a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development.

Cingulate reported in October 2022 the execution of a Master Services Agreement (MSA) with Societal CDMO to manufacture all clinical, registration and commercial batches of Cingulate’s lead candidate, CTx-1301, a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD).

“Stimulants have been used in clinical practice for over 50 years, and subsequent formulations have grown in complexity as companies tried to extend the efficacy of these compounds,” said Shane Schaffer, Chairman and CEO, Cingulate. “With our proprietary Precision Timed Release technology, CTx-1301 is designed to deliver dexmethylphenidate at three precise, pre-defined times throughout the day and stands to provide patients with efficacy through the entire active day – unlike traditionally formulated, extended-release therapies on the market today. Cingulate is pleased to announce that with the successful transfer of CTx-1301 manufacturing processes to Societal CDMO, we are now ready to produce the tablet supply needed for our ongoing and upcoming pivotal Phase 3 studies.”

As outlined in the terms of the MSA, Societal CDMO has successfully completed the construction of a manufacturing suite outfitted with equipment supplied by Cingulate that aims to accommodate the company’s proprietary manufacturing processes.

“After laying the groundwork and completing the transfer of Cingulate’s proprietary manufacturing processes to our facility in Gainsville, Georgia, we’re ready to produce the supply of CTx-1301 needed for the Company’s Phase 3 trials and regulatory milestones,” said David Enloe, CEO of Societal CDMO. “We are pleased with the progress we’ve made in this partnership thus far, particularly as it pertains to our ability to implement the new manufacturing approach required for Cingulate’s innovative PTR platform. With the successful transfer of these manufacturing processes complete, we look forward to continuing to grow our relationship with Cingulate through its multiple upcoming clinical milestones planned for this year.”

Cingulate has completed the first cohort of its Phase 3 adult onset and duration trial and has now initiated the second cohort, with results expected in the third quarter of 2023. In addition to the Phase 3 adult dose-optimization study, the Company plans to commence its pivotal Phase 3 fixed-dose pediatric and adolescent study in mid-2023.

Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024.