Business
Cingulate Announces Positive Top-Line Results from Phase 3 Adult Efficacy and Safety Trial of CTx-1301 (dexmethylphenidate) for ADHD
Results Indicative that CTx-1301 Provides Entire Active-Day Efficacy with Optimal Onset and Duration KANSAS CITY, Kan., July 11, 2023 (GLOBE NEWSWIRE) --
About this update from Cingulate Inc.
[{"type":"text","content":"Results Indicative that CTx-1301 Provides Entire Active-Day Efficacy with Optimal Onset and Duration\nKANSAS CITY, Kan., July 11, 2023 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced positive top-line results from its Phase 3 adult trial of its lead candidate, CTx-1301 (dexmethylphenidate), a novel, investigational treatment being developed as a true, once-daily stimulant medication for attention deficit/hyperactivity disorder (ADHD), upon approval from the U.S. Food and Drug Administration (FDA). Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator in the Phase 3 CTx-1301-022 study who conducted the primary efficacy evaluations, AISRS and PERMP, stated, “From my observation the changes in the Adult ADHD Investigator Symptom Rating Scale (AISRS; a scale that measures aspects of ADHD in adults) demonstrated a positive effect in subjects that received CTx-1301 versus subjects that received placebo. I was also impressed with the overall improvement (change from baseline) of PERMP scores in subjects who were randomized to CTx-1301 compared to placebo. Although a secondary endpoint, the established CGI scale for severity of illness demonstrated clinical improvement in severity of illness. Overall, this in combination with the favorable safety profile, bodes well for future Phase 3 studies.” The Phase 3 CTx-1301-022 study (NCT05631626), which assessed efficacy and safety along with onset and duration of CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting, demonstrated a meaningful trend in improving ADHD symptoms with a rapid onset of action and entire active-day duration. After a 5-week dose optimization period, subjects were either randomized to their optimized dose of CTx-1301 or placebo. Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the Permanent Product Measure of Performance (PERMP) (effect size 0.88 to 2.6; with an average of 1.79) compared to subjects randomized to placebo. The overall effect size showed a trend toward significance with a p-value of 0.089 despite the modest samp...