Cingulate Presents Trial Results From Phase 3 Adult Efficacy And Safety Trial Of CTx-1301 For ADHD

(RTTNews) - Cingulate Inc. (CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release or PTR drug delivery platform technology, announced Friday details results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301 (dexmethylphenidate), for the treatment of attention deficit/hyperactivity disorder or ADHD.

Cingulate shares were gaining around 13 percent in pre-market activity on Nasdaq.

Cingulate's lead candidate, CTx-1301, utilizes Cingulate's proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD.

The Phase 3 CTx-1301-022 study (NCT05631626) assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults, aged ranging 18 to 55 years, with ADHD in an adult laboratory classroom setting.

The company noted that the data from the trial, presented at the 2023 Psych Congress, did not achieve statistical significance on the primary efficacy endpoint. But, it demonstrated a trend toward significance in improving Permanent Product Measure of Performance or PERMP scores with CTx-1301 compared to placebo.

Clinical Global Impression Scale scores with CTx-1301 compared to placebo also showed significant improvements even though the study was not powered for statistical significance.

CTx-1301 demonstrated a favorable safety profile in the trial compared to placebo. No patients reported experiencing insomnia during the randomized period.

The full results from the study was presented on September 8 at the 36th Annual Psych Congress, in Nashville, TN.

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