Cingulate Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day ...

Trial Results Expected 1H 2023

Company to Host Investor and Business Development Meetings Adjacent to Upcoming J.P. Morgan Healthcare Conference in San Francisco

KANSAS CITY, Kan., Jan. 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 the initiation of the first Phase 3 clinical trial of its lead candidate CTx-1301, a novel, investigational, trimodal, extended release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD).

Along with the commencement of its Phase 3 trial, the Company announced that Shane J Schaffer, Chairman and Chief Executive Officer (CEO), will host investor and business development meetings January 9-11, 2023, in San Francisco, CA. The meetings will take place at the same time as the annual J.P. Morgan Healthcare Conference. To request a meeting, please contact Cingulate Investor Relations at mkreps@darrowir.com.

The Phase 3 clinical trial is an adult dose-optimization study to assess the onset and duration of efficacy along with the safety of CTx-1301 in adults with ADHD compared to placebo. The trial is expected to take three months to complete and initial results are expected in the first half of 2023.

“Stimulants have been the gold standard for ADHD treatment for over half of a century, and while these medications can be effective in addressing ADHD symptoms, no currently available formulation has been able to offer patients a single dose providing efficacy across the entire active day,” said Shane J Schaffer, Chairman and CEO, Cingulate. “Developing a true once-daily stimulant medication for ADHD means, along with addressing the crash-and-rebound effect, that we eliminate the problematic booster and recovery doses that sixty percent of patients have to take every single day. In addition to the added cost and complexity of multiple doses, boosters have the potential to be abused or diverted, and often cause unwanted side effects due to the timing of when they are taken and the manner in which they are released in the body.”

Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, no currently available medications offer a single oral dose that provides patients entire active-day efficacy. This Phase 3 trial is being conducted in an Adult Laboratory Setting (ALS) which has been used extensively to evaluate the efficacy of ADHD medications. CTx-1301 is the first medication aiming to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours.

“Cingulate’s approach to ADHD provides medication from proven molecules already available and well understood by providers, but for the first time ever, in a single tablet that is designed to provide entire active-day duration,” said Ann Childress, M.D., President, Center for Psychiatry and Behavior Medicine, Inc., and lead investigator in the CTx-1301 Phase 3 trial. “Physicians have been wanting a treatment that provides entire active-day efficacy to treat ADHD. CTx-1301 is specifically designed to deliver three releases of medication, eliminating the need for a booster pill, with the goal of improving patient outcomes.”

Cingulate’s proprietary PTR platform unlocks the opportunity to provide once-daily, multi-dose delivery tablets in large addressable markets, including the $18 billion U.S. ADHD market. Cingulate’s approach is designed to provide entire active-day efficacy and a fast onset of action in a single tablet with the potential for improved tolerability. Additionally, Cingulate’s approach aims to reduce patient cost by offering eight dose strengths that medical professionals can use to optimize a patient’s medication with a single co-pay.

The PTR platform has the opportunity to be used for delivery of medications in other large markets, including anxiety (CTx-2103 in development), insomnia, depression, bipolar disorder, Parkinson’s disease, xerostomia (dry mouth), migraine, and hypothyroidism. Cingulate is available to partner with existing therapeutic providers in these and other categories to improve delivery and provide ideal, once-daily dosing solutions for patients.

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 Trial
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 ALS study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. 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 ALS, 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 ALS visit. The duration of the full ALS visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within seven days after the full ALS 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 ALS study. Secondary objectives include determination of the onset and duration of clinical effect of CTx-1301 in treating ADHD in adults in an ALS 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 New Drug Application (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
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature.

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