Business
Cingulate Successfully Manufactures Clinical Supply – Initiation of Pediatric Phase 3 Studies to Commence in July and August
Announcement Confirms Cingulate on Track with Development and Regulatory Milestones KANSAS CITY, Kan., June 29, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc.
About this update from Cingulate Inc.
[{"type":"text","content":"Announcement Confirms Cingulate on Track with Development and Regulatory Milestones\nKANSAS CITY, Kan., June 29, 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 it has successfully manufactured the clinical supply for upcoming pivotal Phase 3 trials of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder (ADHD). All doses of CTx-1301 are now available for both pivotal Phase 3 pediatric and adolescent clinical trials, with the fixed-dose study scheduled to begin the week of July 24. “We have effectively collaborated with our manufacturing partner, Societal CDMO, to successfully manufacture all doses required to initiate our pivotal Phase 3 pediatric and adolescent clinical program, and we look forward to the initiation of the fixed-dose study,” said Laurie A. Myers, PhD, Chief Operating Officer, Cingulate. “This accomplishment ensures that we remain firmly on track, adhering to our previously announced timelines.” CTx-1301 is a novel, investigational treatment being developed as a true, once-daily stimulant medication for ADHD upon approval from the U.S. Food and Drug Administration (FDA). Cingulate recently completed a Phase 3 adult onset and duration study of CTx-1301 with results expected 3Q 2023. In addition, the Company plans to initiate two pivotal Phase 3 trials in pediatric and adolescent patients – a fixed dose study and a dose-optimized onset and duration study in a laboratory classroom setting – in 3Q 2023. Assuming positive clinical results from its Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in mid-2024 under the Section 505(b)(2) pathway. About Attention Deficit/Hyperactivity Disorder (ADHD)ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this g...