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 positive top-line results from its Phase 3 adult
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).
Ann Childress, M.D., President, Center for
Psychiatry and Behavior Medicine, Inc., and lead investigator in
the Phase 3 CTx-1301-022 study who conducted the primary efficacy
evaluations, AISRS and PERMP, stated, “From my observation the
changes in the Adult ADHD Investigator Symptom Rating Scale
(AISRS; a scale that measures aspects of ADHD in adults)
demonstrated a positive effect in subjects that received CTx-1301
versus subjects that received placebo. I was also impressed with
the overall improvement (change from baseline) of PERMP scores in
subjects who were randomized to CTx-1301 compared to placebo.
Although a secondary endpoint, the established CGI scale for
severity of illness demonstrated clinical improvement in severity
of illness. Overall, this in combination with the favorable
safety profile, bodes well for future Phase 3 studies.”
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, demonstrated a meaningful trend
in improving ADHD symptoms with a rapid onset of action and entire
active-day duration. After a 5-week dose optimization period,
subjects were either randomized to their optimized dose of CTx-1301
or placebo. Subjects who were randomized to their optimized dose of
CTx-1301 showed improvements on the Permanent Product Measure of
Performance (PERMP) (effect size 0.88 to 2.6; with an average of
1.79) compared to subjects randomized to placebo.
The overall effect size showed a trend
toward significance with a p-value of 0.089 despite the modest
sample size. A Meta-Analysis conducted by Faraone and Glatt
(Clinical Psychiatry 71:6 June 2010) using 11 published studies
with long-acting stimulants in adults demonstrated the average
effect size to be 0.73 (approximate range 0.5 to 0.9). Subjects
randomized to CTx-1301 demonstrated an effect size of 1.41 at 30
minutes and an effect size of 0.98 at 16 hours. Effect size
represents the magnitude of a change in an outcome or the strength
of a relationship, the practical significance. The practical
significance shows that the effect is large enough to be meaningful
in the real world. The larger the effect size the more meaningful
the outcome.
In addition, the secondary outcome using the
Clinical Global Impression (CGI) Scale for severity of illness was
associated with a decrease in the severity of illness in subjects
randomized to CTx-1301 compared to placebo. This is noteworthy as
the purpose of this study was to obtain estimates of effect size
and it was not anticipated that significant treatment differences
would be observed. CTX-1301 was well tolerated; 9% of the subjects
that were randomized to CT-x-1301 experienced treatment emergent
adverse events (TEAEs), while 30% of subjects that were randomized
to placebo experienced TEAEs. Patient reported outcomes on the
overall satisfaction with CTx-1301 compared to subject’s prior ADHD
medication was favorable.
“I’m incredibly proud of our team for reaching
this important clinical milestone. This Phase 3 trial is a major
validation of what Cingulate has set out to accomplish: create the
only ADHD medication that overcomes the major unmet needs of
available treatments with clear and unmatched differentiation,”
said Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “We
believe that the analysis of the full data set from this trial,
along with completing our two upcoming trials in pediatric and
adolescent patients, will allow us to submit a New Drug Application
for CTx-1301 by mid-2024, and most importantly, provide patients,
physicians, and payors a product that can provide exceptional ADHD
treatment.”
Full results from the Phase 3 CTx-1301-022
trial, including safety data and patient reported outcomes from a
pre- and post-trial questionnaire, are being submitted for
presentation at upcoming medical meetings.
In addition to the Phase 3 adult
dose-optimization study, Cingulate plans to initiate its pivotal
Phase 3 fixed-dose pediatric and adolescent study this month and a
dose-optimization onset and duration trial 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 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 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 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 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 re
vise 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-126-0724
Cingulate (NASDAQ:CINGW)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Cingulate (NASDAQ:CINGW)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024