KANSAS CITY - 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, announced full results from the Phase 3 adult efficacy and safety study of its lead candidate, CTx-1301, for the treatment of attention deficit/hyperactivity disorder (ADHD), presented on September 8th at the 36th Annual Psych Congress, in Nashville, TN.

A poster describing this data was selected as a finalist for the Psych Congress's First Annual Poster Awards.

The Phase 3 CTx-1301-022 study (NCT05631626) 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. The data from the trial, presented at the 2023 Psych Congress, did not achieve statistical significance on the primary efficacy endpoint but demonstrated a trend toward significance in improving Permanent Product Measure of Performance (PERMP) scores with CTx-1301 compared to placebo. Clinical Global Impression Scale [CGI-S]) scores with CTx-1301 compared to placebo also showed significant improvements even though the study was not powered for statistical significance.

'Even with currently available extended-release formulations of dexmethylphenidate, many patients require longer duration of efficacy and must add a second, or booster, dose to ensure treatment effect over their entire active day. CTx-1301 is designed to release dexmethylphenidate multiple times throughout the day in just one tablet, with the last release happening around the time that plasma concentrations of other stimulants start to wane,' said Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc. and lead investigator. 'The treatment effect size of CTx-1301 in this trial was notable - starting at 30 minutes and remaining consistent over 16 hours - and demonstrated the ability of CTx-1301 to improve upon ADHD symptoms in patients over an entire active day. If approved, this would allow physicians to avoid prescribing the immediate-release booster doses that over 60 percent of patients are currently using to extend the efficacy of their medications2.'

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

'Along with a restricted duration of efficacy, another limitation of current stimulant-based treatments for ADHD is the phenomena of crash and rebound they produce. This can result in the recurrence or exaggeration of ADHD symptoms,' said Raul Silva, M.D., Chief Science Officer, Cingulate.

'To address this, we designed CTx-1301 to be a once-daily, rapid-onset tablet that is meant to provide entire active-day coverage along with a controlled descent in blood levels to mitigate the crash or rebound by avoiding the precipitous drop in blood levels usually associated with stimulants. We are encouraged by the Phase 3 data which should correlate with CTx-1301's onset and duration of action, thus improving ADHD symptoms from morning to night, all while offering a favorable safety profile.'

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 (FDA).

In addition to this Phase 3 adult dose-optimization study, Cingulate initiated its pivotal Phase 3 fixed-dose pediatric and adolescent study in July 2023, as well as a dose-optimization onset and duration trial in pediatric patients in August 2023.

Detailed Results from Phase 3 Adult Safety and Efficacy Trial of CTx-1301 Demonstrate Improvements in ADHD Symptoms with Optimal Onset and Duration

Subjects who were randomized to their optimized dose of CTx-1301 showed improvements on the PERMP scores (effect size 0.88 to 2.60; average of 1.79) compared to subjects randomized to placebo, with a trend towards statistical significance for PERMP ratings over the 16-hour period (p=0.089). The treatment effect size of CTx-1301 was 1.41 at 30 minutes and 0.98 at 16 hours, which corresponded to onset and duration of effect. For comparison, a meta-analysis using 11 published studies of long-acting stimulants in adults found the average effect size to be 0.73 (approximately ranging from 0.5 to 0.9)1.

A key secondary endpoint of the trial was a change in CGI-S scores from baseline (pre-dose) at Visit 2 to Visit 8. CGI-S scores showed significant improvements in severity of illness in patients taking CTx-1301 (-1.2) compared to placebo (0.0), (p

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