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Cingulate Announces Positive Fed/Fast Study Results of CTx-1301 ADHD Lead Asset

The primary endpoints demonstrate that CTx-1301 can be taken with or without food

CTx-1301 is designed as a true active whole day treatment for ADHD

KANSAS CITY, Kan., Feb. 23, 2023 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ:ENG), a biopharmaceutical company using its proprietary Precision Timed Release (PTR) drug delivery technology to build and advance a pipeline of next-generation pharmaceutical products, today announced positive results from study CTx-1301- 003 evaluating the effect of food on absorption of its lead candidate CTx-1301. CTx-1301 is a new, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the US Food and Drug Administration (FDA) for the treatment of attention-deficit/hyperactivity disorder (ADHD).

The study showed that CTx-1301 can be taken with or without food. Multiple pharmacokinetic (PK) measurements were made, 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 drug that treats ADHD for a full active day, and critical to this is ensuring a pharmacokinetic profile tailored to the unique attributes of stimulant drugs and ADHD , regardless of food intake,” said Shane J. Schaffer, PharmD, president and CEO, Cingulate. “The results of this study are critical 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 study for CTx-1301, a dose optimization efficacy and safety study in adults to evaluate onset and duration, with results expected in the third quarter of 2023 In addition, the Company plans to initiate its pivotal Phase 3 study, a fixed-dose, placebo-controlled study in pediatric and adolescent patients with ADHD, in mid-2023.

“CTx-1301 was developed to deliver the proven efficacy of stimulants by addressing key challenges associated with available formulations, including suboptimal onset and duration along with burdensome medication regimens that often lead to non-compliance, discontinuation, and treatment misuse or diversion,” 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 offers rapid onset, favorable tolerability profile, and active all-day efficacy addresses the increased unmet needs of patients. ADHD patients and providers. “

CTx-1301 Pharmacokinetics in both fed and fasted states
In study CTx-1301-003 (NCT04449250), 23 healthy adult subjects (age range: 18 to 50 years) were randomized in one of two sequences to receive a single 25 mg dose of CTx-1301 on two occasions ( once with a high standard fatty breakfast and once on an empty stomach). Both doses were administered with 8 ounces of water and frequent blood samples were taken over a 28-hour period after each dose in order to define the absorption and elimination profile of dexmethylphenidate (i.e., pharmacokinetics or pharmacokinetics).

The primary pharmacokinetic endpoints of this study were the maximum plasma concentration achieved after each dose (Cmax) and the amount of dexmethylphenidate absorbed into the blood expressed as the area of ​​the plasma drug concentration versus time curve (AUC). Knowledge of these two pharmacokinetic parameters that define the maximum and total extent of exposure is essential for regulatory approval of a drug.

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

The full results, including data on secondary endpoints measuring half-life and time to onset, were presented for presentation at an upcoming medical meeting.

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

In the United States, approximately 6.4 million (11%) children and adolescents under the age of 18 have been diagnosed with ADHD. Of this group, approximately 80% receive treatment, with 65% showing clinical symptoms of ADHD that persist into adulthood. The prevalence of ADHD in adults is estimated to be approximately 11 million patients (4.4%), nearly double the size of the segment of children and adolescents combined, however, only approximately 20% receive treatment.

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

About CTx-1301
Cingulate’s lead candidate, CTx-1301, uses the company’s proprietary PTR drug delivery platform to create a breakthrough multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, an FDA-approved compound for the treatment of ADHD. Dexmethylphenidate belongs to the class of stimulant drugs and increases the activity of norepinephrine and dopamine in the brain to influence attention and behavior.

While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the longstanding challenge remains, providing patients with the full length of action of an active day. The CTx-1301 is designed to accurately deliver three drug releases at a predefined time, ratio, and release style to optimize patient care in a single tablet. The result is rapid onset and active all-day efficacy, with the third dose being released as other stimulant extended-release products begin to wear off.

The Company has initiated the first of two Phase 3 clinical studies of CTx-1301 in support of its new drug application. The fixed-dose Phase 3 pivotal study in children and adolescents is expected to begin in mid-2023.

Learn about Precision Timed Release (PTR) platform technology.
Cingulate is developing ADHD and anxiety disorder product candidates capable of true once-daily dosing using the company’s innovative PTR drug delivery platform technology. Incorporates a proprietary Erosion Barrier Layer (EBL) that provides precise, pre-defined timing control of drug release without drug release before expected release. EBL technology is enclosed around a drug-containing core to give a tablet-in-a-tablet dosage form. It is designed to erode at a controlled rate until eventually the drug is released from the central tablet. The EBL formulation, Oralogik, is licensed from BDD Pharma.

Cingulate intends to use 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 administered multiple times per day at specific and pre-defined time intervals and delivered in a way that would offer a significant improvement over existing therapies.

For more information, visit Cingulate.com/technology.

About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company using its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceuticals designed to improve the lives of patients affected by frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment results. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology can be employed to develop future product candidates, including the treatment of 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 regarding future events affecting our business, including statements regarding our plans, assumptions, expectations, beliefs and goals with respect to product development , clinical studies, clinical and regulatory timelines, market opportunities, competitive position, business strategies, potential growth opportunities and other statements of a predictive nature.

These statements are generally identified by the use of words such as “may”, “might”, “should”, “would”, “believe”, “anticipate”, “foresee”, “estimate”, “expect”, “intend” . , “plan”, “continued”, “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 due to various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our annual Form 10-K report filed with the SEC on March 28, 2022. All forward-looking statements speak only as of the date they are made and we undertake no obligation 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.

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

Thomas Dalton Vice President, Investors and Public Relations, [email protected] (913) 942-2301

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


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