Full Press Release Details
Initiates Final Study for Lead ADHD Asset CTx-1301
Million of additional Capital Recently Raised Strengthening Balance Sheet
CITY, Kan., September 12, 2024 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 commenced its final FDA-required
study, which is a food effect study, for CTx-1301 (dexmethylphenidate) for the treatment of Attention Deficit Hyperactivity Disorder
(ADHD). A data readout from the study is expected by the end of 2024.
Cingulate has raised over $10 million in additional capital since the middle of August 2024, 58% of this amount from its at the market
facility, and has received notification from Nasdaq that Cingulate is now in compliance with Nasdaq listing requirements.
are pleased to have raised additional substantial capital, which allows us to focus on advancing the final activities required for NDA
submission of our lead asset, CTx-1301, which is targeted for mid 2025. Initiating the final study for CTx-1301 is a key milestone moving
us one step closer to NDA submission," said Cingulate Chairman and CEO Shane J. Schaffer.
study is an assessment of the effect of food on the absorption of the highest dose of CTx-1301. An open-label, randomized, single-dose,
two-period, two-treatment (Fed vs. Fasted), two-sequence, crossover study In Healthy adult subjects to assess the effect of food on the
bioavailability of CTx-1301 (dexmethylphenidate) of the highest dose.
Attention Deficit/Hyperactivity Disorder (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.
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.
Precision Timed Release (PTR ) Platform Technology
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.
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.
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President, Investor & Public Relations, Cingulate