KANSAS CITY, Kansas, Oct. 24, 2022 (GLOBE NEWSWIRE) — Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company using its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and make advance a pipeline of next-generation pharmaceuticals, today announced the signing of a master services agreement (MSA) with Societal CDMO, Inc. (NASD: SCTL), a bi-contract development and manufacturing organization -coastal (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in the therapeutic development of small molecules.
With capabilities ranging from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging of a wide range of therapeutic dosage forms, Societal CDMO will manufacture all clinical, registration and commercial batches of lead candidate CTx-1301 of Cingulate, an experimental drug for the treatment of attention deficit/hyperactivity disorder (ADHD). Societal CDMO will dedicate a dedicated manufacturing suite within its Gainesville, GA facility and outfit it with proprietary equipment provided by Cingulate.
“Choosing the right manufacturing partner is critical to the success of any pharmaceutical business, and we are excited to have the opportunity to work with an organization that has the capability and operational expertise to deliver quality manufacturing at every scale. “said Cingulate Chairman & CEO Shane J. Schaffer. “As Cingulate continues to advance its mission to bring next-generation medicines to patients where standard treatments fail to deliver optimal results, we believe Societal CDMO is the right partner at the right time.”
“The work we will be conducting on this MSA with Cingulate provides an excellent opportunity for Societal CDMO to showcase our team’s extensive expertise in formulating and manufacturing complex therapies to help deliver innovative medicines to patients. in need. In fact, the innovative nature of Cingulate’s PTR technology platform requires us to install specialized manufacturing equipment provided by Cingulate in a dedicated suite within our facilities, demonstrating Societal CDMO’s ability to customize solutions to the unique needs of our individual clients,” said David Enloe, Managing Director of Societal CDMO. “We are delighted that Cingulate has trusted Societal CDMO to carry out these essential activities to support CTx-1301 at such a critical time in its clinical development and commercialization.
Clinical Update
Cingulate is preparing to initiate a Phase 3 adult dose optimization study later this year for its lead candidate, CTx-1301, to assess onset and duration of efficacy and efficacy. safety in adults with ADHD. The study is scheduled to begin in December 2022 and will be led by Dr. Ann Childress, MD, ADHD expert and leading board-certified psychiatrist.
“We believe the onset and duration study is a critical trial for physicians, payers, and patients, and we are delighted that Dr. Ann Childress is leading this investigation,” Schaffer said. “She has conducted over 180 clinical studies and worked on most major psychiatric drugs that have been approved over the past 30 years by various major pharmaceutical companies, and we deeply appreciate her expertise.”
Additionally, our phase 3 study of the safety and efficacy of CTx-1301 in children and adolescents at a fixed dose is now expected to commence in mid-2023 after the final two dosings of this study are completed by Societal CDMO. Assuming we receive positive clinical results from our Phase 3 trials and dietary effects study with data expected in December 2022, we plan to submit a New Drug Application (NDA) to the Food and Drug Administration. (FDA) in the first half of 2024 under the 505(b)(2) route.
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 a continuous pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development.
In the United States, approximately 6.4 million children and adolescents (11%) under the age of 18 have been diagnosed with ADHD. Of this group, about 80% receive treatment, 65% of whom have clinical symptoms of ADHD that persist into adulthood. The prevalence of ADHD in adults is estimated at around 11 million patients (4.4%), twice the size of the child and adolescent segment combined, however, only around 20% receive treatment.
Although there is no single medical, physical, or genetic test for ADHD, mental health professionals and qualified physicians can provide a diagnostic evaluation after gathering information from several sources, including: lists ADHD symptom checklists, standardized behavioral rating scales, a detailed history of current functioning, and information obtained from family members or significant others who know the person well. Some practitioners will also perform cognitive ability and academic achievement tests to rule out a possible learning disability.
About the 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 API dexmethylphenidate, a US Food and Drug Administration (FDA)-approved compound. USA for the treatment of ADHD. Dexmethylphenidate is in the class of stimulant drugs and increases norepinephrine and dopamine activity in the brain to affect attention and behavior.
Although stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge remains to provide patients with a full active day’s duration of action. The CTx-1301 precisely delivers three releases of medication at the pre-set 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 released around the time other time-released 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 United States and are decisive for filing the NDA with the FDA.
About Cingulate®
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company that uses its proprietary PTR™ drug delivery platform technology to create and advance a pipeline of next-generation pharmaceuticals designed to improve the lives of patients suffering from commonly diagnosed diseases characterized by suboptimal daily dosing regimens and treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR™ technology could be used to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com.
About the societal CDMO
Societal CDMO (NASDAQ: SCTL) is a bi-coastal contract development and manufacturing organization (CDMO) with capabilities ranging from pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of forms therapeutic dosages with a primary focus in the area of small molecules. With expertise in solving complex manufacturing issues, Societal CDMO is a leading CDMO providing therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization , packaging and logistics to the global pharmaceutical market.
In addition to our experience in handling DEA controlled substances and in the development and manufacturing of modified release dosage forms, Societal CDMO has the expertise to complete our clients’ pharmaceutical development and manufacturing projects, regardless of their level of complexity. We do all of this in our best facilities, which total 145,000 square feet, in Gainesville, Georgia and San Diego, California.
Societal CDMO: Bringing science to society. For more information on Societal CDMO’s customer solutions, visit societalcdmo.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 opinions 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”, “could”, “should”, “will”, “believe”, “anticipate”, “plan”, “estimate”, “expect”. “, “to the intention of”. ”, “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 due to 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 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.
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