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 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. To request a meeting,
please contact Cingulate Investor Relations at
mkreps@darrowir.com.
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, Cingulate. “Developing a true
once-daily stimulant medication for ADHD means, along with
addressing the crash-and-rebound effect, that we eliminate the
problematic booster and recovery doses that sixty percent of
patients have to take every single day. In addition to the added
cost and complexity of multiple doses, boosters have the potential
to be abused or diverted, and often cause unwanted side effects due
to the timing of when they are taken and the manner in which they
are released in the body.”
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 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 Ann Childress, M.D., President, Center for Psychiatry and
Behavior Medicine, Inc., and lead investigator in the CTx-1301
Phase 3 trial. “Physicians have been wanting a treatment that
provides entire active-day efficacy to treat ADHD. CTx-1301 is
specifically designed to deliver three releases of medication,
eliminating the need for a booster pill, with the goal of improving
patient outcomes.”
Cingulate’s proprietary PTR platform unlocks the
opportunity to provide once-daily, multi-dose delivery tablets in
large addressable markets, including the $18 billion U.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.
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 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.
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
TrialThe 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. 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.
About CTx-1301Cingulate’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 TechnologyCingulate is developing ADHD and
anxiety disorder product candidates capable of achieving true
once-daily dosing using the Company’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 28, 2022. 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: |
|
Media
Relations: |
Matt Kreps |
Thomas Dalton |
Melyssa Weible |
Darrow Associates |
Vice President, Investor & Public Relations, Cingulate |
Elixir Health Public Relations |
mkreps@darrowir.com |
tdalton@cingulate.com |
mweible@elixirhealthpr.com |
(214) 597-8200 |
(913) 942-2301 |
(201) 723-5805 |
CING-US-117-0124
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