Cingulate Completes Fed/Fast Study Assessing Food Effect with CTx-1301, Lead Candidate for Treatment of ADHD

Study Conducted by Dr. Vince Clinical Research

KANSAS CITY, Kan., Nov. 01, 2022 (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 completion of its study assessing the effect of food on absorption of its lead candidate CTx-1301, an investigational medication for the treatment of Attention Deficit / Hyperactivity Disorder (ADHD). Results are expected by the end of the year.

Dr. Brad Vince, Founder & CEO of Dr. Vince Clinical Research (DVCR), served as principal investigator on the study. KCAS Bioanalytical & Biomarker Services is conducting the pharmacokinetic (PK) analysis.

“As Cingulate proceeds with its mission to bring next-generation medications to patients where standard-of-care treatments result in suboptimal outcomes, we are pleased to have completed this trial advancing our understanding of the absorption and bioavailability of our potentially paradigm-shifting compound for ADHD treatment,” said Shane J. Schaffer, Cingulate Chairman & CEO.

“Additionally, it is a privilege to be working with two Kansas City companies on this clinical study,” Schaffer continued. “Dr. Brad Vince is an industry veteran who has served as an investigator in over 600 clinical trials and authored numerous scientific publications. We are excited that the initiation of our study coincided with the launch of Dr. Vince Clinical Research, one of the most innovative and technologically advanced Phase 1 units in the world.”

“Shane’s early career experience at Kansas City-based Marion Laboratories, founded by philanthropist and visionary Ewing Kauffman, uniquely positions Cingulate to be the next major pharmaceutical company in Kansas City,” Vince stated. “I admire his vision and aspiration for growth, entrepreneurship, and support to our community. It is an honor for our research organization to conduct this important clinical trial for Cingulate with its possible ground-breaking drug candidate CTx-1301.”

Bioavailability of CTx-1301

• CTx-1301-003 (NCT04449250) was an open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study in 26 healthy adult subjects, 18 to 50 years of age. Subjects were randomized into one of two sequences (a fasted state, and a fed state [after a high-fat test meal]) and dosed with a 25mg dose of CTx-1301
• The primary PK endpoints were maximum concentration (expressed as C_max) during the first 28 hours after dosing, and the total amount of the active pharmaceutical ingredient (API), dexmethylphenidate, in the blood (expressed as the area the plasma drug concentration-time curve [AUC]) from dosing to the time of the last measured concentration (AUC_0-last) and from dosing taken to the limit as the end time becomes arbitrarily large (AUC_0-∞)
• Results from the study are expected in Q4 2022 and will shed light on how food impacts the absorption and bioavailability of CTx-1301

Pharmacokinetics (PK)
PK refers to the activity of drugs in the body over a period of time, including the extent of Absorption, Distribution, Metabolism and Excretion (ADME). A fundamental understanding of PK parameters is required to design an appropriate drug regimen for a patient, to help plan subsequent studies and to support labeling.  

Overall, the effect of food on the PK of orally administered long-acting stimulants is generally minimal: following a high-fat meal, there is potential for the rate and extent of absorption to be either slightly decreased or increased compared to the fasted state. However, a thorough understanding of the unique PK profile and pharmacodynamic response of investigational formulations allows developers to optimize the most effective formulation of their therapy based on the clinical needs and dosing preferences of patients.

About Attention Deficit/Hyperactivity Disorder (ADHD)
Attention Deficit/Hyperactivity Disorder (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), 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 API dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (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 precisely delivers 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 is currently preparing for multiple Phase 3 clinical studies of CTx-1301 to support its upcoming New Drug Application (NDA) submission. These studies will be conducted in the U.S. and are instrumental for the filing of the NDA to the U.S. FDA, expected in late 2023 or early 2024.

About the CTx-1301-003 Fed-Fast Study
CTx-1301-003 (NCT04449250) was an open-label, randomized, single-dose, two-sequence, two-period, in-clinic crossover study in 26 healthy adult subjects, 18 to 50 years of age. Subjects were randomized into one of two sequences (a fasted state, and a fed state [after a high-fat test meal]) and dosed with a 25mg dose of CTx-1301. In the fasted arm, subjects were dosed with CTx-1301 on an empty stomach. In the fed arm, subjects consumed a test meal over 30 minutes prior to being dosed with CTx-1301. Participants in both arms were required to complete an overnight fast of 10.5 hours, to take their dose with approximately eight fluid ounces of water, and to withhold from food consumption for at least four hours post-dose.

Primary outcome measures were evaluating PK parameters for each arm: maximum concentration (C_max), and the area under the plasma drug concentration-time curve (AUC) from time 0 to infinity (AUC_0-∞), and area under the curve from time 0 to 28 hours (AUC_0-last). Secondary outcome measures included various measurements to evaluate PK, AUC and safety of CTx-1301.

About Precision Timed Release™ (PTR™) Platform Technology and OralogiK™
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®
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.

About Dr. Vince Clinical Research
Dr. Vince Clinical Research (DVCR) is a world-class CRO (contract research organization) with a custom-built, green-designed headquarters and research complex encompassing three buildings in Overland Park, KS. DVCR’s complex includes a 90-bed clinical pharmacology unit featuring a combination of luxurious and private research suites and a GMP-compliant pharmacy with positive and negative pressure compounding rooms. DVCR specializes in conducting clinical trials for both healthy normal volunteers and patient populations in a wide variety of early phase trials. By leveraging both technology and one of the country’s most experienced leadership teams, DVCR provides Smarter, Faster Data™ to its biopharmaceutical clients.

About KCAS Bioanalytical & Biomarker Services
KCAS, Flowmetric and Active Biomarkers have united as a KCAS family of companies. We are rapidly growing as a leading bioanalytical CRO organization employing top scientific talent in the lab and supportive front office teams to provide exceptional customer service. We are uniquely positioned to provide our clients w/ comprehensive GLP/GCP compliant development services from early discovery support through product registration and beyond. The collaboration of the three entities allows for global support in bioanalytical, biomarker and cellular and molecular assay services as well as clinical kitting and storage management. We operate in state-of-the-art facilities located in Kansas City and Philadelphia, USA, Milan, Italy and Lyon, France with significant expansion opportunities. The combined business structure provides the capacity to support customers globally as well as, advance the mission of providing high-quality services to the biotech and pharmaceutical industries.

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. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 28, 2022. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

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