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 the first cohort of its Phase 3
adult onset and duration trial of its lead candidate, CTx-1301
(dexmethylphenidate), for attention deficit/hyperactivity disorder
(ADHD).
The Phase 3 CTx-1301-022 study (NCT05631626) is
assessing the onset and duration of CTx-1301 in up to 25 adults
(age range: 18-55 years) with ADHD in an adult laboratory classroom
setting. The study is comprised of a screening period, a five-week
dose-optimization phase, a double-blind randomized phase, and a
seven-day safety follow-up period. Results from the trial are
expected in 3Q 2023.
“We’re pleased with the speed in which our first
cohort of this Phase 3 trial was able to be completed, underscoring
the ADHD community’s interest in new stimulant treatment options
and affirming our goal of having full trial results by third
quarter 2023,” said Shane J Schaffer, Chairman and CEO, Cingulate.
“There is a large and growing population of adults with ADHD who
with appropriate diagnosis stand to benefit from effective entire
active-day efficacy, and we’re confident that an optimized version
of the already-established active ingredient in CTx-1301,
dexmethylphenidate, could be an important addition to the $22
billion ADHD market.”
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 stimulant medication offers a single
oral dose that provides patients entire active-day efficacy.
“Our lead asset, CTx-1301, is being developed to
provide a once-daily oral treatment that delivers a fast onset of
action, an improved tolerability profile, and – importantly –
entire active-day efficacy via our proprietary Precision Timed
Release™ platform technology,” said Matthew Brams, MD, Chief
Medical Officer, Cingulate. “Along with eight dosing strengths to
best optimize patients unique dosing needs, the CTx-1301 clinical
profile and proprietary tablet design stand to effectively
eliminate the need for short-acting booster doses that are
prescribed to over 60 percent of patients, and which are a primary
source of non-compliance, abuse and misuse of these medicines.”
In addition to the Phase 3 adult
dose-optimization study, Cingulate plans to commence its pivotal
Phase 3 fixed-dose pediatric and adolescent study in mid-2023.
Assuming positive clinical results from the Phase 3 trials,
Cingulate plans to submit a New Drug Application (NDA) for CTx-1301
in the first half of 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 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 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 up to 25 adults (age range: 18-55 years) with
ADHD. The study will be comprised of a screening period, a
dose-optimization phase, a double-blind randomized phase, and a
seven-day safety follow-up period. 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 ALC,
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 ALC visit. The duration of the full ALC visit will
be approximately 17 hours. Subjects will have an in-clinic safety
follow-up visit within seven days after the full ALC 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 ALC study. Secondary objectives include
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 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 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 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:Matt
KrepsDarrow Associatesmkreps@darrowir.com (214) 597-8200
Thomas DaltonVice President, Investor &
Public Relations, Cingulatetdalton@cingulate.com(913) 942-2301
Media RelationsMelyssa WeibleElixir Health
Public Relationsmweible@elixirhealthpr.com (201) 723-5805
CING-US-121-0424
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