Press Release

Primary Endpoints Demonstrate CTx-1301 Can be Taken With or Without Food

CTx-1301 is Designed as a True, Entire Active-Day Treatment for ADHD

KANSAS CITY, Kan., Feb. 23, 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 the CTx-1301-003 study assessing the effect of food on absorption of its lead candidate CTx-1301. CTx-1301 is 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).

The trial demonstrated that CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were taken and adverse events were consistent with previous findings and indicate a favorable tolerability profile.

“We are developing CTx-1301 to be the first true, once-daily stimulant medication that treats ADHD over an entire active day, and crucial to this is ensuring a pharmacokinetic profile customized for the unique attributes of stimulant medications and ADHD, regardless of food intake,” said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The results of this study are instrumental in confirming that we have identified the optimal formulation of CTx-1301, paving the way for our Phase 3 trials.”

Cingulate recently announced the initiation of its first Phase 3 trial for CTx-1301, an adult dose-optimization efficacy and safety study to assess onset and duration, with results expected in the third quarter of 2023. In addition, the Company plans to initiate its pivotal Phase 3 trial, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“CTx-1301 is being developed to provide the proven efficacy of stimulants while addressing the key challenges associated with available formulations, including sub-optimal onset and duration along with burdensome medication regimens which often lead to non-compliance, discontinuation, and abuse or diversion of the treatment,” said Matthew Brams, MD, Chief Medical Officer, Cingulate. “The ability to provide patients with a once-daily treatment that has the flexibility to be taken with or without food and delivers fast onset, a favorable tolerability profile, and entire active-day efficacy addresses the biggest unmet needs facing ADHD patients and providers.”

CTx-1301 Pharmacokinetics in Both Fed and Fasted States
In CTx-1301-003 (NCT04449250), 23 healthy adult subjects (age range: 18 to 50 years) were randomized into one of two sequences to receive a single 25 mg dose of CTx-1301 on two occasions (once with a standard high fat breakfast and once on an empty stomach). Both doses were administered with 8 oz of water and frequent blood samples were obtained for a period of 28 hours after each dose in order to define the absorption and elimination profile of dexmethyphenidate (i.e. the pharmacokinetics or PK).

The primary PK endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) as well as the extent of dexmethylphenidate absorbed into the blood expressed as the area the plasma drug concentration vs. time curve (AUC). Knowledge of these two PK parameters which definine maximum and total extent of exposure are essential for a drug’s regulatory approval.

“The study of CTx-1301 in the fasted versus fed state demonstrated that food did not delay absorption, and thus should not affect onset of action. Therefore, we expect that CTx-1301 can be administered orally with or without food, however patients should be advised to take the medication consistently as such," said Raul Silva, MD, Chief Science Officer, Cingulate. “What is important is that the delivery system worked irrespective of the presence of food intake and this study provides important clinical knowledge for providers in the treatment of ADHD patients.”

Full results, including data on secondary endpoints measuring half-life and time to onset, are being submitted for presentation at a forthcoming medical meeting.

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 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 New Drug Application 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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Investor Relations:
Matt Kreps
Darrow Associates
mkreps@darrowir.com
(214) 597-8200

Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
tdalton@cingulate.com
(913) 942-2301

Media Relations
Melyssa Weible
Elixir Health Public Relations
mweible@elixirhealthpr.com
(201) 723-5805

CING-US-118-0224