The Cingulate Inc (NASDAQ: CING) stock price rallied 77.47% after releasing positive top-line results from its clinical trial testing the effectiveness of its CTx-1301 drug candidate for the treatment of attention-deficit/hyperactivity disorder (ADHD). The study assessed food's impact on the absorption of Cingulate’s lead candidate CTx-1301.
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Investors cheered the results, which indicated that CTx-1301 could be taken with or without food. The company was testing the drug’s effectiveness in either scenario, and many appreciated the positive results. CTx-1301 is a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate.
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Dexmethylphenidate is a compound approved by the U.S. Food and Drug Administration (FDA) to treat ADHD. Cingulate has already started a phase 3 clinical trial of CTx-1301 in adult patients to optimise the dosage while testing the drug’s efficacy and safety. The trial will also assess the drug’s onset and duration, with results expected in Q3 2023.
The company also plans to launch a pivotal phase 3 study in pediatric and adolescent patients with ADHD around mid-2023. The study will be a fixed-dose placebo-controlled trial.
Matthew Brams, MD, Cingulate Inc’s Chief Medical Officer, said: “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.”
Shane J. Schaffer, PharmD, Cingulate Inc’s Chairman and CEO, said: “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. 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.”
Raul Silva, MD, cingulate Inc’s Chief Science Officer, said: “The study of CTx-1301 in the fasted versus fed state demonstrated that food did not delay absorption, and thus should not affect the onset of action. Therefore, we expect that CTx-1301 can be administered orally with or without food, however, patients should be advised to take the medication consistently as such.”
Over 4.47 million Cingulate shares had changed hands at the time of writing.
*This is not investment advice.
Cingulate stock price.
The Cingulate stock price rallied 77.47% to trade at $1.97, from Thursday’s closing price of $1.11.
YOUR CAPITAL IS AT RISK. 76% OF RETAIL CFD ACCOUNTS LOSE MONEY.