Cingulate Inc. (NASDAQ: CING) has presented full results from its Phase 3 adult efficacy and safety trial of CTx-1301, a novel dexmethylphenidate formulation for attention deficit/hyperactivity disorder (ADHD), at the 36th Annual Psych Congress in Nashville, Tennessee. The poster presentation, recognized as a finalist for the conference's inaugural Poster Awards, highlighted the potential of CTx-1301 to address a significant unmet need in ADHD treatment.
The Phase 3 trial (CTx-1301-022, NCT05631626) evaluated the efficacy, safety, onset, and duration of CTx-1301 in 21 adult participants with ADHD in a laboratory classroom setting. Results demonstrated a trend toward significant improvement in ADHD symptoms with rapid onset of action and sustained efficacy throughout the active day.
"Through our ongoing research, we continue to build evidence on the ability of CTx-1301 to offer patients with ADHD a true, once-daily stimulant medication providing entire active-day efficacy with a rapid onset of action and excellent tolerability," said Shane J. Schaffer, PharmD, Chairman and CEO of Cingulate.
Innovative Drug Delivery Platform
CTx-1301 utilizes Cingulate's proprietary Precision Timed Release™ (PTR™) drug delivery platform technology, which incorporates a multi-core formulation designed to deliver three precisely timed releases of medication in a single tablet. This novel approach aims to overcome the limitations of current extended-release stimulants, which often fail to provide consistent symptom control throughout the entire day.
The PTR technology features an Erosion Barrier Layer (EBL) that controls drug release at pre-defined times with no premature release. This tablet-in-tablet dose form, known as Oralogik™, is licensed from BDD Pharma and is designed to erode at a controlled rate until the drug is released from the core tablet.
Dr. Ann Childress, President of the Center for Psychiatry and Behavior Medicine, Inc., and lead investigator of the study, presented the full results. The poster, titled "A Phase 3, Dose-Optimized, Double-Blind, Placebo Controlled, Single-Center, Parallel Efficacy and Safety Laboratory Classroom Study in Adults with Attention Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301 (dexmethylphenidate)," was displayed on September 9, 2023.
Study Design and Results
The Phase 3 study employed a rigorous design that included a screening period, a five-week dose-optimization phase, a double-blind randomized phase, and a seven-day safety follow-up period. During the dose-optimization phase, subjects were titrated to doses ranging between 25 mg and 50 mg of CTx-1301.
The study utilized an adult laboratory classroom setting to facilitate repeated assessments throughout the day, evaluating the onset and duration of efficacy. Eligible subjects were randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice visit with four Product Measure of Performance (PERMP) assessments.
While specific efficacy data points were not disclosed in detail, the company reported that CTx-1301 demonstrated a trend towards significance in improving ADHD symptoms with a rapid onset of action and entire active-day duration. The third dose release is timed to occur when other extended-release stimulant products typically begin to wear off, potentially addressing the "wearing off" effect that many patients experience with current treatments.
Addressing a Significant Unmet Need
ADHD affects approximately 6.4 million children and adolescents in the United States, with 65-90% of these patients continuing to exhibit clinical symptoms into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients, almost double the size of the child and adolescent segment combined. However, only about 20% of adults with ADHD receive treatment.
Current stimulant medications, while considered the gold standard for ADHD treatment due to their efficacy and safety, often require multiple daily doses or fail to provide consistent symptom control throughout the day. CTx-1301 aims to address these limitations by providing a true once-daily dosing option with rapid onset and entire active-day efficacy.
Ongoing Development and Future Plans
In addition to the completed Phase 3 adult dose-optimization study, Cingulate has initiated a pivotal Phase 3 fixed-dose pediatric and adolescent study in July 2023, as well as a dose-optimization onset and duration study in pediatric patients in August 2023.
Assuming positive clinical results from these Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 to the U.S. Food and Drug Administration in the second half of 2024 under the Section 505(b)(2) pathway, which allows for some reliance on previous findings of safety and efficacy for the active ingredient.
Beyond ADHD, Cingulate is exploring the potential of its PTR technology for other therapeutic areas, including anxiety disorders, where precise, timed delivery of multiple doses of medication throughout the day could provide significant advantages over existing therapies.
The company's approach represents a potential paradigm shift in ADHD treatment, offering the possibility of improved medication adherence, more consistent symptom control, and enhanced quality of life for millions of patients with ADHD.
