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,
today announced it has completed its Phase 3 adult
dose-optimization trial of its lead candidate, CTx-1301
(dexmethylphenidate), a novel, investigational treatment being
developed as a true, once-daily stimulant medication for attention
deficit/hyperactivity disorder (ADHD), upon approval from the U.S.
Food and Drug Administration (FDA).
The Phase 3 CTx-1301-022 study
(NCT05631626) assessed the onset and duration of
CTx-1301 in 21 adults (age range: 18-55 years) with ADHD in an
adult laboratory classroom setting. Results from the trial are
expected in 3Q 2023 and will be submitted for presentation at a
future medical meeting.
“Currently available stimulant medications have
failed to address the large and growing unmet need for true
once-daily dosing in ADHD treatment, and onset and duration are two
of the most important efficacy parameters that Cingulate plans
to improve upon to achieve this,” said Raul R. Silva, M.D.,
Chief Science Officer, Cingulate. “If the Phase 3 CTx-1301-022
study results are positive, these data will add to the growing body
of evidence from earlier trials showing that CTx-1301 has the
potential to offer patients best-in-class onset and duration.”
The United States Centers for Disease Control
(CDC) has cited a 10 percent increase in stimulant medicine
prescriptions in the adult ADHD population. Of the multitude of
ADHD medications available, no methylphenidate medication offers a
single oral dose that provides patients entire active-day
efficacy.
“Stimulant medications are the most effective
tools we have to address ADHD symptoms in patients, but their short
half-life require that more than 60 percent of patients be
prescribed booster doses – a primary source of non-compliance and
misuse of this class of medicines,” said Ann Childress, M.D.,
President, Center for Psychiatry and Behavior Medicine, Inc., and
lead investigator in the Phase 3 CTx-1301-022 study.
“Cingulate’s formulation of dexmethylphenidate
is designed to cover a patient’s entire active day and, if the
Phase 3 trials are successful, would give physicians the ability to
avoid the booster dose, and ultimately provide patients a single
administration to improve outcomes.” Dr. Childress continued, “The
American Professional Society of ADHD and Related Disorders
(APSARD) announced plans to develop and publish guidelines for the
diagnosis and treatment of ADHD in adults. As there are currently
no guidelines in the United States, the APSARD guidelines will
address this critical need for health care providers, patients, and
the public.” Dr. Childress is the President of APSARD through
2023.
In addition to the Phase 3 adult
dose-optimization study, Cingulate plans to initiate its pivotal
Phase 3 fixed-dose pediatric and adolescent study and its pivotal
dose-optimization onset and duration trial in pediatric patients in
3Q 2023. Assuming positive clinical results from the Phase 3
trials, Cingulate plans to submit a New Drug Application (NDA) for
CTx-1301 in mid-2024 under the Section 505(b)(2) pathway.
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 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.
About the CTx-1301 Phase 3 Adult
Dose-Optimization StudyThe 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 adult laboratory
classroom (ALC) study with CTx-1301 in 21 adults (age range: 18-55
years) with ADHD. The study was comprised of a screening period, a
dose-optimization phase, a double-blind randomized phase, and a
seven-day safety follow-up period. Subjects underwent a screening
visit prior to entering a five-week dose-optimization phase.
During the dose-optimization phase, subjects had
weekly visits and were titrated to doses ranging between 25 mg and
50 mg of CTx-1301. Cingulate utilized an ALC, which enabled it to
facilitate repeated assessments over the course of a day to
evaluate the onset and duration of efficacy provided by CTx-1301.
Eligible subjects were 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 took their assigned/randomized dose over the following
seven-day period. On the seventh day, subjects completed a full ALC
visit. The duration of the full ALC visit was approximately 17
hours. Subjects had an in-clinic safety follow-up visit within
seven days after the full ALC visit.
The primary objective of CTx-1301-022 was to
evaluate the efficacy of CTx-1301 compared to placebo in treating
adults with ADHD in an ALC study. Secondary objectives included
determination of the onset and duration of clinical effect of
CTx-1301 in treating ADHD in adults in an ALC study and to
determine safety and tolerability of CTx-1301 compared to placebo.
The study also evaluated the quality and satisfaction of prior
medication to CTx-1301. The Phase 3 clinical trial program for
CTx-1301 is being conducted in the U.S. and is instrumental for the
filing of the NDA to the FDA, expected in mid-2024.
About CTx-1301Cingulate’s 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 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.
About Precision Timed Release™ (PTR™)
Platform TechnologyCingulate 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 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. For more information visit
Cingulate.com/technology.
About Cingulate Inc.Cingulate
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.
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 views and
assumptions with respect to future events regarding our business,
including statements with respect to our plans, assumptions,
expectations, beliefs and objectives with respect to product
development, clinical studies, clinical and regulatory timelines,
market opportunity, competitive position, business strategies,
potential growth opportunities and other statements that are
predictive in nature.
These statements are generally identified by the
use of such words as “may,” “could,” “should,” “would,” “believe,”
“anticipate,” “forecast,” “estimate,” “expect,” “intend,” “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
as a result of 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 10, 2023. All forward-looking statements speak only as
of the date on which they are made, and we undertake no duty 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.
Investor Relations: |
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Media Relations |
Matt KrepsDarrow Associatesmkreps@darrowir.com (214) 597-8200 |
Thomas DaltonVice President, Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301 |
Melyssa WeibleElixir Health Public
Relationsmweible@elixirhealthpr.com (201) 723-5805 |
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