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
completion of its study assessing the effect of food on absorption
of its lead candidate CTx-1301, an investigational medication for
the treatment of Attention Deficit / Hyperactivity Disorder (ADHD).
Results are expected by the end of the year.
Dr. Brad Vince, Founder & CEO of Dr. Vince
Clinical Research (DVCR), served as principal investigator on the
study. KCAS Bioanalytical & Biomarker Services is conducting
the pharmacokinetic (PK) analysis.
“As Cingulate proceeds with its mission to bring
next-generation medications to patients where standard-of-care
treatments result in suboptimal outcomes, we are pleased to have
completed this trial advancing our understanding of the absorption
and bioavailability of our potentially paradigm-shifting compound
for ADHD treatment,” said Shane J. Schaffer, Cingulate Chairman
& CEO.
“Additionally, it is a privilege to be working
with two Kansas City companies on this clinical study,” Schaffer
continued. “Dr. Brad Vince is an industry veteran who has
served as an investigator in over 600 clinical trials and authored
numerous scientific publications. We are excited that the
initiation of our study coincided with the launch of Dr. Vince
Clinical Research, one of the most innovative and technologically
advanced Phase 1 units in the world.”
“Shane’s early career experience at Kansas City-based Marion
Laboratories, founded by philanthropist and visionary Ewing
Kauffman, uniquely positions Cingulate to be the next major
pharmaceutical company in Kansas City,” Vince stated. “I
admire his vision and aspiration for growth, entrepreneurship, and
support to our community. It is an honor for our research
organization to conduct this important clinical trial for Cingulate
with its possible ground-breaking drug candidate CTx-1301.”
Bioavailability of CTx-1301
- CTx-1301-003 (NCT04449250) was an
open-label, randomized, single-dose, two-sequence, two-period,
in-clinic crossover study in 26 healthy adult subjects, 18 to 50
years of age. Subjects were randomized into one of two sequences (a
fasted state, and a fed state [after a high-fat test meal]) and
dosed with a 25mg dose of CTx-1301
- The primary PK endpoints were
maximum concentration (expressed as Cmax) during the first 28 hours
after dosing, and the total amount of the active pharmaceutical
ingredient (API), dexmethylphenidate, in the blood (expressed as
the area the plasma drug concentration-time curve [AUC]) from
dosing to the time of the last measured concentration (AUC0-last)
and from dosing taken to the limit as the end time becomes
arbitrarily large (AUC0-∞)
- Results from the study are expected
in Q4 2022 and will shed light on how food impacts the absorption
and bioavailability of CTx-1301
Pharmacokinetics (PK)PK refers
to the activity of drugs in the body over a period of time,
including the extent of Absorption, Distribution, Metabolism and
Excretion (ADME). A fundamental understanding of PK parameters is
required to design an appropriate drug regimen for a patient, to
help plan subsequent studies and to support
labeling.
Overall, the effect of food on the PK of orally
administered long-acting stimulants is generally minimal: following
a high-fat meal, there is potential for the rate and extent of
absorption to be either slightly decreased or increased compared to
the fasted state. However, a thorough understanding of the unique
PK profile and pharmacodynamic response of investigational
formulations allows developers to optimize the most effective
formulation of their therapy based on the clinical needs and dosing
preferences of patients.
About Attention Deficit/Hyperactivity
Disorder (ADHD)Attention Deficit/Hyperactivity Disorder
(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),
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 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 API dexmethylphenidate, a compound approved by the U.S. Food
and Drug Administration (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 precisely delivers 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 is currently preparing for multiple
Phase 3 clinical studies of CTx-1301 to support its upcoming New
Drug Application (NDA) submission. These studies will be conducted
in the U.S. and are instrumental for the filing of the NDA to the
U.S. FDA, expected in late 2023 or early 2024.
About the CTx-1301-003 Fed-Fast
StudyCTx-1301-003 (NCT04449250) was an open-label,
randomized, single-dose, two-sequence, two-period, in-clinic
crossover study in 26 healthy adult subjects, 18 to 50 years of
age. Subjects were randomized into one of two sequences (a fasted
state, and a fed state [after a high-fat test meal]) and dosed with
a 25mg dose of CTx-1301. In the fasted arm, subjects were dosed
with CTx-1301 on an empty stomach. In the fed arm, subjects
consumed a test meal over 30 minutes prior to being dosed with
CTx-1301. Participants in both arms were required to complete an
overnight fast of 10.5 hours, to take their dose with approximately
eight fluid ounces of water, and to withhold from food consumption
for at least four hours post-dose.
Primary outcome measures were evaluating PK
parameters for each arm: maximum concentration (Cmax), and the area
under the plasma drug concentration-time curve (AUC) from time 0 to
infinity (AUC0-∞), and area under the curve from time 0 to 28 hours
(AUC0-last). Secondary outcome measures included various
measurements to evaluate PK, AUC and safety of CTx-1301.
About Precision Timed Release™ (PTR™)
Platform Technology and OralogiK™ Cingulate 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® 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.
About Dr. Vince Clinical ResearchDr. Vince
Clinical Research (DVCR) is a world-class CRO (contract
research organization) with a custom-built, green-designed
headquarters and research complex encompassing three buildings in
Overland Park, KS. DVCR’s complex includes a 90-bed clinical
pharmacology unit featuring a combination of luxurious and private
research suites and a GMP-compliant pharmacy with positive and
negative pressure compounding rooms. DVCR specializes in conducting
clinical trials for both healthy normal volunteers and patient
populations in a wide variety of early phase trials. By leveraging
both technology and one of the country’s most experienced
leadership teams, DVCR provides Smarter, Faster Data™ to its
biopharmaceutical clients.
About KCAS Bioanalytical & Biomarker
ServicesKCAS, Flowmetric and Active Biomarkers have united
as a KCAS family of companies. We are rapidly growing as a leading
bioanalytical CRO organization employing top scientific talent in
the lab and supportive front office teams to provide exceptional
customer service. We are uniquely positioned to provide our clients
w/ comprehensive GLP/GCP compliant development services from early
discovery support through product registration and beyond. The
collaboration of the three entities allows for global support in
bioanalytical, biomarker and cellular and molecular assay services
as well as clinical kitting and storage management. We operate in
state-of-the-art facilities located in Kansas City and
Philadelphia, USA, Milan, Italy and Lyon, France with significant
expansion opportunities. The combined business structure provides
the capacity to support customers globally as well as, advance the
mission of providing high-quality services to the biotech and
pharmaceutical industries.
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.
Contacts: |
|
Investor
Relations Thomas Dalton VP, Investor & Public
Relations, CingulateTDalton@cingulate.com913-942-2301 |
Media RelationsMelyssa WeibleElixir Health Public
Relationsmweible@elixirhealthpr.com201-723-5805 |
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