お知らせ • Jan 05
Cingulate Inc. Initiates Phase 3 Study of Lead Asset CTx-1301, Designed as a True Entire Active-Day Treatment for ADHD
Cingulate Inc. announced the initiation of the first Phase 3 clinical trial of its lead candidate CTx-1301, a novel, investigational, trimodal, extended-release tablet formulation of dexmethylphenidate, a compound approved by the U.S. Food and Drug Administration (FDA) for the treatment of attention deficit/hyperactivity disorder (ADHD). Along with the commencement of its Phase 3 trial, the Company announced that Shane J Schaffer, Chairman and Chief Executive Officer (CEO), will host investor and business development meetings January 9-11, 2023, in San Francisco, CA. The meetings will take place at the same time as the annual J.P. Morgan Healthcare Conference. The Phase 3 clinical trial is an adult dose-optimization study to assess the onset and duration of efficacy along with the safety of CTx-1301 in adults with ADHD compared to placebo. The trial is expected to take three months to complete and initial results are expected in the first half of 2023. Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the U.S. living with ADHD, no currently available medications offer a single oral dose that provides patients entire active-day efficacy. This Phase 3 trial is being conducted in an Adult Laboratory Setting (ALS) which has been used extensively to evaluate the efficacy of ADHD medications. CTx-1301 is the first medication aiming to achieve fast onset of action (in 30 minutes or less) and efficacy that lasts up to 16 hours. Cingulate’s proprietary PTR platform unlocks the opportunity to provide once-daily, multi-dose delivery tablets in large addressable markets, including the $18 billionU.S. ADHD market. Cingulate’s approach is designed to provide entire active-day efficacy and a fast onset of action in a single tablet with the potential for improved tolerability. Additionally, Cingulate’s approach aims to reduce patient cost by offering eight dose strengths that medical professionals can use to optimize a patient’s medication with a single co-pay. The PTR platform has the opportunity to be used for delivery of medications in other large markets, including anxiety (CTx-2103 in development), insomnia, depression, bipolar disorder, Parkinson’s disease, xerostomia (dry mouth), migraine, and hypothyroidism. Cingulate is available to partner with existing therapeutic providers in these and other categories to improve delivery and provide ideal, once-daily dosing solutions for patients. 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%) aged under the age of 18 have been diagnosed with ADHD. Among this group, approximately 80% receive treatment, with 65% demonstrating clinical ADHD symptoms that persist into adulthood. Adult ADHD prevalence is estimated at approximately 11 million patients (4.4%), almost double the size of the child and adolescent segment combined, however, only an estimated 20% 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. The first Phase 3 study (CTx-1301-022, NCT05631626 [3]) for CTx-1301 is a single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel efficacy and safety ALS study with CTx-1301 in approximately 25 adults aged 18 to 55 years with ADHD. The study will be comprised of a screening period, a dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase. Subjects will undergo a screening visit prior to entering a five-week dose-optimization phase. During the dose-optimization phase, subjects will have weekly visits and will be titrated to doses ranging between 25 mg and 50 mg of CTx-1301. Cingulate is utilizing an ALS, which enables the Company to facilitate repeated assessments over the course of a day to evaluate the onset and duration of efficacy provided by CTx-1301. Eligible subjects will be randomized to their optimal dose or placebo in a 1:1 ratio after completing a practice visit with four Permanent Product Measure of Performance (PERMP) assessments. Subjects will take their assigned/randomized dose over the following seven-day period. On the seventh day, subjects will complete a full ALS visit. The duration of the full ALS visit will be approximately 17 hours. Subjects will have an in-clinic safety follow-up visit within seven days after the full ALS visit. The primary objective of CTx-1301-022 is to evaluate the efficacy of CTx-1301 compared to placebo in treating adults with ADHD in an ALS study. Secondary objectives include determination of the onset and duration of clinical effect of CTx-1301 in treating ADHD in adults in an ALS study and to determine safety and tolerability of CTx-1301 compared to placebo. The study will also evaluate the quality and satisfaction of prior medication to CTx-1301. The Phase 3 clinical trial program for CTx-1301 will be conducted in the U.S. and is instrumental for the filing of the New Drug Application (NDA) to the FDA, expected in the first half of 2024. Cingulate’s lead candidate, CTx-1301, utilizes the Company’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. Dexmethylph enidate 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 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. The company has initiated the first of two Phase 3 clinical studies of CTx-1301 to support its NDA submission. The pivotal, Phase 3 fixed-dose trial in children and adolescents is scheduled to begin in mid-2023.
