By Chris Wack
Cingulate said it saw positive results from a Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301, for the treatment of attention deficit/hyperactivity disorder.
The Phase 3 CTx-1301 study assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults with ADHD in an adult laboratory classroom setting.
The data from the trial didn’t achieve statistical significance on the primary efficacy endpoint, but did demonstrate a trend toward significance in improving Permanent Product Measure of Performance scores with CTx-1301 compared to placebo.
Clinical Global Impression Scale scores with CTx-1301 compared with placebo also showed significant improvements, even though the study wasn’t powered for statistical significance.
The company said CTx-1301 demonstrated a favorable safety profile in the trial compared with placebo. No patients reported experiencing insomnia during the randomized period.
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.
Cingulate shares were up 14% to 66 cents in premarket trading.
Write to Chris Wack at [email protected]
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