- Cingulate Inc (NASDAQ:CING) announced positive topline results from the CTx-1301-003 study assessing the effect of food on the absorption of its lead candidate CTx-1301.
- CTx-1301 is a trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the FDA for attention-deficit/hyperactivity disorder (ADHD).
- The trial demonstrated that CTx-1301 could be taken with or without food.
- Multiple pharmacokinetic (PK) measurements were taken, and adverse events were consistent with previous findings and indicated a favorable tolerability profile.
- “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,” said Raul Silva, Chief Science Officer of Cingulate.
- Cingulate recently initiated 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 Q3 of 2023.
- In addition, the company plans to initiate its pivotal Phase 3 trial study in pediatric and adolescent patients with ADHD in mid-2023.
- Price Action: CING shares are up 68.5% at $1.87 during the premarket session on the last check Friday.
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