Business
Cingulate Inc. Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Clinical and Business Update
CTx-1301 Phase 3 Adult Dose-Optimization Study Ongoing; Results Expected 3Q 2023 Positive Top-Line Data from CTx-1301 Fed/Fast Study Announced, Full Results
About this update from Cingulate Inc.
[{"type":"text","content":"CTx-1301 Phase 3 Adult Dose-Optimization Study Ongoing; Results Expected 3Q 2023 Positive Top-Line Data from CTx-1301 Fed/Fast Study Announced, Full Results Submitted for Presentation at Forthcoming Medical Meeting CTx-1301 Pivotal Phase 3 Trial in Pediatric/Adolescent Patients Planned to Begin Mid-2023 KANSAS CITY, Kan., March 10, 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 its financial results for the three and 12 months ended December 31, 2022, and provided a clinical and business update. Highlights include multiple clinical updates on CTx-1301, the Company’s lead candidate being investigated as a true, once-daily treatment for attention deficit/hyperactivity disorder (ADHD). “The fourth quarter of 2022 was instrumental for Cingulate, during which we executed a Master Services Agreement with Societal CDMO to manufacture CTx-1301, and successfully initiated our Phase 3 Adult Onset and Duration Trial,” said Shane J. Schaffer, PharmD, Cingulate Chairman and CEO. “With the first of two CTx-1301 Phase 3 studies underway and the second planned to begin mid-2023, we’ve made significant progress towards bringing the first true, once-daily stimulant to market that addresses all major unmet needs in ADHD.” CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Phase 3 Adult Dose-Optimization Trial on Track for Q3 2023 ResultsThe Phase 3 CTx-1301-022 (NCT05631626) trial is evaluating the efficacy and safety of CTx-1301 in adults with ADHD in an laboratory classroom setting, which has been used extensively to evaluate the efficacy of ADHD medications. Following initiation in December, the dose optimization phase for the first cohort has commenced. The trial is being led by Ann C. Childress, MD, practicing psychiatrist and president of the American Professional Society for ADHD and Related Disorders (APSARD). Dr. Childress has conducted over 180 clinical studies and is considered a preeminent global ADHD expert. “While we have many approved stimulant medications at our disposal as clinicians, my long-standing ...