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 the presentation of full results from the Phase 3 adult
efficacy and safety trial of its lead candidate, CTx-1301
(dexmethylphenidate), for the treatment of attention
deficit/hyperactivity disorder (ADHD) at the 36th Annual Psych
Congress, taking place September 6-10, 2023 in Nashville, TN.
The poster was accepted as a finalist for the
first annual Psych Congress Poster Awards, which will be awarded
onsite at the conference. Poster Awards will be on display on
Saturday, September 9, from 6:45-8:15pm CT.
“Through our ongoing research, we continue to
build evidence on the ability of CTx-1301 to offer patients with
ADHD a true, once-daily stimulant medication providing entire
active-day efficacy with a rapid onset of action and excellent
tolerability,” said Shane J. Schaffer, PharmD, Chairman and CEO,
Cingulate. “We believe that the Psych Congress’ selection of our
Phase 3 data as a finalist for its first-ever Poster Awards
demonstrates the importance of our product’s ability to improve
treatment for ADHD.”
Ann Childress, M.D., President, Center for
Psychiatry and Behavior Medicine, Inc., and lead investigator, will
present the full results from the Phase 3 CTx-1301-022 trial.
Presentation Details:
Poster Title: A Phase 3, Dose-Optimized,
Double-Blind, Placebo Controlled, Single-Center, Parallel Efficacy
and Safety Laboratory Classroom Study in Adults with Attention
Deficit/Hyperactivity Disorder (ADHD) Using CTx-1301
(dexmethylphenidate)Presenter Name: Ann Childress,
M.D.Poster Number:
1596317Date/Time: September 9, 2023, from
6:45-8:00pm CTLocation: Nashville Music City
Center in the Karl Dean Ballroom, section A2
CTx-1301 is a novel, investigational treatment
being developed as a true, once-daily stimulant medication for
ADHD, upon approval from the U.S. Food and Drug Administration
(FDA).
Last month Cingulate released top-line data from
the Phase 3 CTx-1301-022 study (NCT05631626), which assessed
efficacy and safety along with onset and duration of CTx-1301 in 21
adults (age range: 18-55 years) with ADHD in an adult laboratory
classroom setting. The data demonstrated a trend towards
significance in improving ADHD symptoms with a rapid onset of
action and entire active-day duration.
In addition to the Phase 3 adult
dose-optimization study, Cingulate initiated its pivotal Phase 3
fixed-dose pediatric and adolescent study in July 2023, as well as
a dose-optimization onset and duration study in pediatric patients
in August 2023. Assuming positive clinical results from the Phase 3
trials, Cingulate plans to submit a New Drug Application (NDA) for
CTx-1301 in the second 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 65-90
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 was a single-center,
dose-optimized, double-blind, randomized, placebo-controlled,
parallel efficacy and safety adult laboratory classroom (ALC) study
of 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 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 the second half of
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 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.
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:Thomas
DaltonVice President, Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301
Matt KrepsDarrow Associatesmkreps@darrowir.com
(214) 597-8200
Media Relations:Melyssa WeibleElixir Health
Public Relationsmweible@elixirhealthpr.com (201) 723-5805
CING-US-128-0924
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