Cingulate announces efficacy results from Phase 3 study of CTx-1301

Cingulate (CING) announced the efficacy results from an FDA required Phase 3, randomized, fixed dose, double blind, placebo controlled clinical study in pediatrics, for its lead asset CTx-1301 for the treatment of Attention Deficit/Hyperactivity Disorder, ADHD. The primary efficacy endpoint of the study was change in total score on the ADHD-RS-5 rating scale. The fixed doses used in the study were 18.75-mg; 25-mg and 37.5-mg. Pending approval by the FDA, Cingulate expects to launch CTx-1301 with a total of eight dosage strengths, six of which are expected to treat patients under the age of 18. Within 5 weeks of subjects receiving once daily dosing of CTx-1301 the p-values for ADHD-RS-5 were 0.018, 0.011 and 0.001 for the 18.75-mg, 25-mg, and 37.5-mg doses, respectively. This level of significance was achieved with less than one third of the planned subjects. In this study, the pre-defined statistical parameter that determined success using the ADHD-RS-5 score at Week 5 compared to Study Day 0 was a p-value of less than 0.017. Effect size represents the magnitude of a change in an outcome, or the strength of a relationship which was calculated for the ADHD-RS-5 primary endpoint versus placebo for each dose at week 5. The mean effect size for long-acting stimulants was 0.73. In this study the statistically significant mean effect size compared to placebo at week 5 was: 0.737 at 18.75-mg; 0.782 at 25-mg; 1.185 at 37.5-mg; an overall effect size of 0.901. The Clinical Global Impression scale is an objective measure of a patient’s change in ADHD symptoms compared to baseline and was monitored during the study. The results of the CGI-I demonstrated that at all tested doses subjects demonstrated an improvement versus the placebo group at week 5.