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Cingulate Announces Successful Transfer of CTx-1301 (dexmethylphenidate) Proprietary PTR™ Manufacturing Processes to Societal CDMO
Scalable Supply of CTx-1301 Ready to be Produced with Cingulate on Track to Meet Previously Announced Clinical Timelines for Phase 3 Trial Program KANSAS
About this update from Cingulate Inc.
Scalable Supply of CTx-1301 Ready to be Produced with Cingulate on Track to Meet Previously Announced Clinical Timelines for Phase 3 Trial Program KANSAS CITY, Kan., May 03, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced the successful completion of the manufacturing transfer of its lead candidate, CTx-1301 (dexmethylphenidate), to Societal CDMO, Inc. (NASDAQ: SCTL), a bi-coastal contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development. Cingulate announced 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 J 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 will 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...