Cingulate Completes First Cohort of Phase 3 Adult Onset and Duration Trial of CTx-1301 (dexmethylphenidate) for ADHD

Trial On Track for 3Q 2023 Results

Pivotal Phase 3 Trial in Pediatric/Adolescent Patients Planned to Begin Mid-2023

KANSAS CITY, Kan., April 04, 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 it has completed the first cohort of its Phase 3 adult onset and duration trial of its lead candidate, CTx-1301 (dexmethylphenidate), for attention deficit/hyperactivity disorder (ADHD).

The Phase 3 CTx-1301-022 study (NCT05631626) is assessing the onset and duration of CTx-1301 in up to 25 adults (age range: 18-55 years) with ADHD in an adult laboratory classroom setting. The study is comprised of a screening period, a five-week dose-optimization phase, a double-blind randomized phase, and a seven-day safety follow-up period. Results from the trial are expected in 3Q 2023.

“We’re pleased with the speed in which our first cohort of this Phase 3 trial was able to be completed, underscoring the ADHD community’s interest in new stimulant treatment options and affirming our goal of having full trial results by third quarter 2023,” said Shane J Schaffer, Chairman and CEO, Cingulate. “There is a large and growing population of adults with ADHD who with appropriate diagnosis stand to benefit from effective entire active-day efficacy, and we’re confident that an optimized version of the already-established active ingredient in CTx-1301, dexmethylphenidate, could be an important addition to the $22 billion ADHD market.”

The United States Centers for Disease Control (CDC) has cited a 10 percent increase in stimulant medicine prescriptions in the adult ADHD population. Of the multitude of ADHD medications available, no stimulant medication offers a single oral dose that provides patients entire active-day efficacy.

“Our lead asset, CTx-1301, is being developed to provide a once-daily oral treatment that delivers a fast onset of action, an improved tolerability profile, and – importantly – entire active-day efficacy via our proprietary Precision Timed Release™ platform technology,” said Matthew Brams, MD, Chief Medical Officer, Cingulate. “Along with eight dosing strengths to best optimize patients unique dosing needs, the CTx-1301 clinical profile and proprietary tablet design stand to effectively eliminate the need for short-acting booster doses that are prescribed to over 60 percent of patients, and which are a primary source of non-compliance, abuse and misuse of these medicines.”

In addition to the Phase 3 adult dose-optimization study, Cingulate plans to commence its pivotal Phase 3 fixed-dose pediatric and adolescent study in mid-2023. Assuming positive clinical results from the Phase 3 trials, Cingulate plans to submit a New Drug Application (NDA) for CTx-1301 in the first half of 2024 under the Section 505(b)(2) pathway.

About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.

In the U.S., approximately 6.4 million children and adolescents (11 percent) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80 percent receive treatment, with 65 percent demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4 percent), almost double the size of the child and adolescent segment combined, however, only an estimated 20 percent receive treatment.

Although there is no single medical, physical, or genetic test for ADHD, qualified mental health care professionals and physicians can provide a diagnostic evaluation after gathering information from multiple sources, including: ADHD symptom checklists, standardized behavior rating scales, detailed histories of past and current functioning, and information obtained from family members or significant others who know the person well. Some practitioners will also conduct tests of cognitive ability and academic achievement to rule out a possible learning disability.

About the CTx-1301 Phase 3 Adult Dose-Optimization Study
The first Phase 3 study (CTx-1301-022, NCT05631626) for CTx-1301 is a single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety adult laboratory classroom (ALC) study with CTx-1301 in up to 25 adults (age range: 18-55 years) with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a seven-day safety follow-up period. Subjects will undergo a screening visit prior to entering a five-week dose-optimization phase.

During the dose-optimization phase, subjects will have weekly visits and will be titrated to doses ranging between 25 mg and 50 mg of CTx-1301. Cingulate is utilizing an ALC, which enables the Company to facilitate repeated assessments over the course of a day to evaluate the onset and duration of efficacy provided by CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice visit with four Permanent Product Measure of Performance (PERMP) assessments. Subjects will take their assigned/randomized dose over the following seven-day period. On the seventh day, subjects will complete a full ALC visit. The duration of the full ALC visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within seven days after the full ALC visit.

The primary objective of CTx-1301-022 is to evaluate the efficacy of CTx-1301 compared to placebo in treating adults with ADHD in an ALC study. Secondary objectives include determination of the onset and duration of clinical effect of CTx-1301 in treating ADHD in adults in an ALC study and to determine safety and tolerability of CTx-1301 compared to placebo. The study will also evaluate the quality and satisfaction of prior medication to CTx-1301.

The Phase 3 clinical trial program for CTx-1301 will be conducted in the U.S. and is instrumental for the filing of the NDA to the FDA, expected in the first half of 2024.

About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes the Company’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. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.

While stimulants are the gold-standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains, providing patients entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to optimize patient care in one tablet. The result is a rapid onset and entire active-day efficacy, with the third dose being released around the time when other extended-release stimulant products begin to wear off.

The Company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.

About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using the Company’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, Oralogik™, is licensed from BDD Pharma.

Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies.

For more information visit Cingulate.com/technology.

About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information visit Cingulate.com.

Forward-Looking Statements
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Investor Relations:
Matt Kreps
Darrow Associates
[email protected]
(214) 597-8200

Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
[email protected]
(913) 942-2301

Media Relations
Melyssa Weible
Elixir Health Public Relations
[email protected]
(201) 723-5805

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