Final Study Completed for Cingulate's Lead Asset CTx-1301
MWN-AI** Summary
Cingulate Inc. (NASDAQ: CING) has reported the completion of its final FDA-required study for its lead asset, CTx-1301 (dexmethylphenidate), aimed at treating Attention Deficit Hyperactivity Disorder (ADHD). This pivotal food effect study involved 26 healthy adults and focused on examining the pharmacokinetic profile of the drug in both fed and fasted states after administering a 50mg dose—its highest dosage. Notably, no serious adverse events were reported during the study. The results, which will clarify the impact of food on CTx-1301's absorption and bioavailability, are anticipated in the second quarter of 2025.
Cingulate’s Chairman and CEO, Shane J. Schaffer, emphasized that CTx-1301 is being developed to provide a true once-daily stimulant option that effectively manages ADHD throughout the day. This study represents a critical milestone in the drug's development, clearing the way for a New Drug Application (NDA) submission to the FDA, anticipated by mid-2025.
CTx-1301 leverages Cingulate's proprietary Precision Timed Release™ (PTR™) platform. This innovative approach is designed to allow for a multi-core formulation that optimally releases dexmethylphenidate in a controlled manner, ensuring continuous therapeutic effectiveness. ADHD affects millions of children and persists into adulthood, with many patients seeking more efficient treatment methodologies.
As Cingulate advances its pipeline and regulatory processes, it aims to enhance treatment options not only for ADHD but also for other therapeutic areas, potentially reshaping the landscape of medication delivery through its proprietary technology.
MWN-AI** Analysis
Cingulate Inc. (NASDAQ: CING) recently announced the completion of its final FDA-required food effect study for CTx-1301, paving the way for a New Drug Application (NDA) submission targeted for mid-2025. This significant milestone indicates Cingulate’s commitment to bringing a once-daily stimulant medication for ADHD to market, aimed at revolutionizing treatment options in a sector with a vast unmet need.
The outcomes of the food effect study are particularly crucial. Initial studies have shown a positive safety profile with no serious adverse events reported, which bolsters confidence in the drug's viability. Additionally, the focus on how food intake affects the bioavailability of CTx-1301 under different metabolic states indicates a sophisticated understanding of pharmacokinetics that may appeal to both clinicians and patients. As dexmethylphenidate has established efficacy, the unique delivery system using Cingulate's Precision Timed Release™ (PTR™) technology promises more precise dosing and sustained effects throughout the day.
With ADHD affecting millions of children and adults, Cingulate is entering a market ripe for innovation. The ADHD treatment segment is growing, particularly for formulations that can offer effective management with more convenient dosing regimens. Given that 20% of adults with ADHD remain untreated, Cingulate’s approach may capture a wider patient base, especially with an emphasis on extended efficacy without multiple doses.
From a market perspective, Cingulate's stock may exhibit volatility as pivotal data from the pending bioavailability study is released in Q2 2025. Investors should monitor this closely alongside broader market trends affecting biopharmaceutical stock performance. As Cingulate approaches its NDA submission, positive data could catalyze significant upward movement in share prices. In contrast, the market may react adversely to delays or unfavorable results. Overall, strategic investment in Cingulate appears promising, particularly as interest in ADHD therapies continues to grow.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
No Serious Adverse Events Reported
Submission of New Drug Application Targeted for Mid 2025
KANSAS CITY, Kan., Jan. 07, 2025 (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, announced today that it has completed its final FDA-required study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The subjects in the study were given a single 50mg dose of CTx-1301, Cingulate’s highest dosage, to determine if the medication can be taken in fed and fasted states. No serious adverse events were reported. A data readout regarding bioavailability with or without food is expected in 2Q 2025.
A study conducted in 2022 using a single 25mg dose of CTx-1301 demonstrated that it could be taken with or without food.
“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 and dosage size,” said Cingulate Chairman and CEO Shane J. Schaffer. “The completion of this study marks another important milestone and is one of the final activities required for NDA submission to the FDA, which is targeted for mid 2025.”
About the Food Effect Study
- 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 50mg 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 Q2 2025 and will confirm 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)
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 65-90 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.
About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’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 continues to be providing patients with an 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.
About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’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 in addition to Anxiety and ADHD 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. To see Cingulate’s PTR Platform, click here .
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. 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 April 1, 2024 and our other filings with the SEC. 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.
Investor & Public Relations:
Thomas Dalton
Vice President, Investor & Public Relations, Cingulate
tdalton@cingulate.com
(913) 942-2301
Matt Kreps
Darrow Associates
mkreps@darrowir.com
(214) 597-8200
FAQ**
How does the successful completion of the food effect study impact the market perception of Cingulate Inc. and its warrants, Cingulate Inc. Warrants CINGW, especially in the context of the upcoming NDA submission for CTx-1301?
What insights can investors derive from the lack of serious adverse events reported in the food effect study regarding the safety and efficacy profile of CTx-1301, and how might this influence the trading patterns of Cingulate Inc. Warrants CINGW?
Given the expected data readout in Q2 2025 highlighting how food affects the absorption of CTx-1301, what implications could this have for the valuation of Cingulate Inc. and its warrants, Cingulate Inc. Warrants CINGW, post-announcement?
Considering the potential market size for ADHD treatments and the features of CTx-1301, how should investors assess the growth prospects of Cingulate Inc. and its associated financial instruments, including Cingulate Inc. Warrants CINGW, following the NDA filing?
**MWN-AI FAQ is based on asking OpenAI questions about Cingulate Inc. Warrants (NASDAQ: CINGW).
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