CTx-1301 (dexmethylphenidate) Proprietary PTR™ Manufacturing Process Transferred to CDMO: Cingulate Celebrates Success!

Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology, has achieved a major milestone with the successful completion of the manufacturing transfer of its lead candidate, CTx-1301 (dexmethylphenidate).

The transfer was conducted by Societal CDMO, Inc. (NASDAQ: SCTL), a bi-coastal CDMO dedicated to providing innovative solutions for complex formulation and manufacturing challenges in small molecule therapeutics. This accomplishment marks an important step forward in advancing Cingulate’s pipeline of next-generation pharmaceutical products.

In October 2022, Cingulate and Societal CDMO entered into a Master Services Agreement that will enable the production of clinical, registration and commercial batches of CTx-1301, an investigational stimulant medication for attention deficit/hyperactivity disorder (ADHD). With the development of this promising new treatment, Cingulate is striving to provide a true, once-daily solution for those in need of ADHD medication.

Cingulate is proud to announce the successful transfer of their proprietary Precision Timed Release technology, CTx-1301, to Societal CDMO. CTx-1301 is designed to deliver dexmethylphenidate at three precise, pre-defined times throughout the day to provide patients with efficacy throughout the active day. This marks a major milestone in Cingulate’s journey towards producing the tablet supply needed for their pivotal Phase 3 studies.

With over 50 years of clinical experience, stimulants have evolved in complexity to extend the efficacy of these compounds, and CTx-1301 is the latest formulation to revolutionize the way we treat patients.

Societal CDMO has accomplished a major milestone in the terms of the MSA: the construction of a cutting-edge manufacturing suite, outfitted with top-of-the-line Cingulate equipment, capable of housing the Company’s unique production processes.

David Enloe, CEO of Societal CDMO, is thrilled with the progress made in the partnership with Cingulate as it pertains to their proprietary manufacturing processes. Now, with the transfer complete, Societal is ready to ramp up production of CTx-1301 for the Company’s Phase 3 trials and other regulatory milestones. Enloe looks forward to continuing the relationship with Cingulate as they embark on their multiple clinical milestones planned for this year.

Cingulate has made great strides in its Phase 3 adult onset and duration trial, having just completed the first cohort and now initiating the second. With results anticipated in the third quarter of 2023, the Company is also gearing up to launch its pivotal Phase 3 fixed-dose pediatric and adolescent study in mid-2023. Together, these trials aim to optimize doses for adults and create effective treatments for children and adolescents.

Cingulate is aiming to submit a New Drug Application (NDA) for CTx-1301 in mid-2024, should the Phase 3 trials yield positive clinical results. This application will be filed under the Section 505(b)(2) pathway, offering an exciting potential milestone in the pursuit of new treatments.

About Attention Deficit/Hyperactivity Disorder (ADHD)

ADHD is a complex and multifaceted disorder that impacts an estimated 5 million children and adults in the United States alone. It is marked by persistent patterns of inattention, hyperactivity, and impulsivity that can interfere with daily functioning, social interactions, and academic performance. This chronic condition can last into adulthood and has the potential to significantly disrupt the lives of those affected by it.

ADHD is a common disorder that affects millions of children and adults in the United States. An estimated 6.4 million children and adolescents under the age of 18 have been diagnosed with ADHD, and of those, 80 percent are receiving treatment.

Unfortunately, only 65 percent of these children display symptoms that continue into adulthood, and even fewer receive treatment as adults. In fact, the adult ADHD population is almost double the size of the child and adolescent segment combined. Yet, only about 20 percent of adults receive treatment, leaving the majority of adults with ADHD untreated.

Diagnosing ADHD isn’t as simple as taking a single medical test; it requires a comprehensive evaluation by a qualified mental health professional or physician. During the assessment, the practitioner may use symptom checklists, behavior rating scales, and detailed histories of past and current functioning, while also gathering information from family members or significant others.

In some cases, tests of cognitive ability and academic achievement may be conducted to rule out a possible learning disability. With the help of this comprehensive evaluation, the practitioner can make an accurate diagnosis of ADHD and provide the best treatment plan for the individual.

About CTx-1301

Cingulate is proud to present CTx-1301, a revolutionary, multi-core formulation of dexmethylphenidate that utilizes the Company’s proprietary PTR drug delivery platform. Dexmethylphenidate is an FDA approved stimulant compound that can help improve attention and behavior by increasing norepinephrine and dopamine activity in the brain. CTx-1301 promises to be a groundbreaking treatment for ADHD.

CTx-1301 promises to revolutionize the treatment of ADHD with its precise three-stage delivery system. This advanced tablet precisely releases medication at the predefined times to ensure patients receive a rapid onset and an entire active-day of efficacy.

For the first time, ADHD sufferers can benefit from a single tablet that provides an entire day of relief, avoiding the need for multiple doses of stimulants that can leave them feeling worn out by the end of the day.

CTx-1301 is set to revolutionize pediatric care, and the Company is leading the charge with two Phase 3 clinical studies to support its NDA submission. The groundbreaking, Phase 3 fixed-dose trial in children and adolescents is slated to start in mid-2023 – a major step towards improved pediatric healthcare.

About Precision Timed Release™ (PTR™) Platform Technology

Cingulate is revolutionizing the way ADHD and anxiety disorders are treated, with a groundbreaking once-daily dosage option that utilizes an innovative PTR drug delivery platform. Through the use of a proprietary Erosion Barrier Layer (EBL), the Oralogik™ technology ensures a precise and pre-defined release of medication without any premature release. This tablet-in-tablet dose form is licensed from BDD Pharma, and is poised to revolutionize the way these conditions are managed.

Cingulate is leveraging its innovative PTR technology to broaden its clinical-stage pipeline and explore new therapeutic areas. By delivering one or more active pharmaceutical ingredients multiple times a day in a precisely-timed manner, Cingulate seeks to surpass existing therapies and offer improved treatments to patients.

About Cingulate Inc.

Cingulate Inc. (NASDAQ: CING) is a biopharmaceutical company on a mission to help patients suffering from often-diagnosed conditions take control of their health. Using its proprietary PTR drug delivery platform technology, Cingulate is developing next-generation pharmaceutical products that offer improved, hassle-free dosing regimens and superior treatment outcomes.

Initially targeting ADHD, Cingulate is researching additional therapeutic areas where its technology can be employed to create potential products, including for treating anxiety disorders. Cingulate is headquartered in Kansas City and is driven to make a real difference in people’s lives.

About Societal CDMO

Societal CDMO is a bi-coastal contract development and manufacturing organization (CDMO) that is revolutionizing the pharmaceutical industry with its comprehensive range of services. From pre-IND development to commercial manufacturing and packaging of small molecules, Societal CDMO provides the global pharmaceutical market with therapeutic development, regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, and logistics services.

With its expertise in solving complex manufacturing problems, Societal CDMO is a leading CDMO and the go-to provider for pharmaceutical innovation and progress.

Bringing Science to Society, Societal CDMO is your go-to partner for all your pharmaceutical development and manufacturing needs. Our best-in-class facilities, totaling 145,000 square feet in Gainesville, Georgia and San Diego, California, give us the capacity to handle complex projects while providing expertise in the handling of DEA controlled substances and modified-release dosage forms. With our years of experience, you can trust that your project is in the best of hands.

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