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Cingulate Announces Positive Top-Line Results from Fed/Fast Study of Lead Asset CTx-1301 for ADHD
Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD KANSAS CITY,
About this update from Cingulate Inc.
[{"type":"text","content":"Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD KANSAS CITY, Kan., Feb. 23, 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 positive top-line results from the CTx-1301-003 study assessing the effect of food on absorption of its lead candidate CTx-1301. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD). The trial demonstrated that CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken and adverse events were consistent with previous findings and indicate a favorable tolerability profile. “We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The results of this study are instrumental in confirming that we have identified the optimal formulation of CTx-1301, paving the way for our Phase 3 trials.” Cingulate recently announced the initiation of its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of 2023. In addition, the Company plans to initiate its pivotal Phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023. “CTx-1301 is being developed to provide the proven efficacy of stimulants while addressing the key challenges associated with available formulations, including sub-optimal onset and duration along with burdensome medication regimens which often lead to non-compliance, discontinuation, and abuse or diversion of the treatment,” said Matthew Brams, MD, Chief Medical Officer, Cingulate. “The ability to provide patients with a once-dai...