Trial Results Expected 1H 2023
Company to Host Investor and Business Development Meetings Adjacent to
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
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.
“Stimulants have been the gold standard for ADHD treatment for over half of a century, and while these medications can be effective in addressing ADHD symptoms, no currently available formulation has been able to offer patients a single dose providing efficacy across the entire active day,” said Shane J Schaffer, Chairman and CEO,
Of the multitude of medications available for the more than 17 million child, adolescent, and adult patients in the
“Cingulate’s approach to ADHD provides medication from proven molecules already available and well understood by providers, but for the first time ever, in a single tablet that is designed to provide entire active-day duration,” said
Cingulate’s proprietary PTR platform unlocks the opportunity to provide once-daily, multi-dose delivery tablets in large addressable markets, including the
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.
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
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.
About the CTx-1301 Phase 3 Trial
The first Phase 3 study (CTx-1301-022, NCT05631626) 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.
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
About CTx-1301
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. 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 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.
About Precision Timed Release™ (PTR™) Platform Technology
For more information visit Cingulate.com/technology.
About
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Vice President, Investor & Public Relations, | Elixir Health Public Relations | |
mkreps@darrowir.com | tdalton@cingulate.com | mweible@elixirhealthpr.com |
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