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 the CTx-1301-003
study assessing the effect of food on absorption of its lead
candidate CTx-1301. CTx-1301 is 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).
The trial demonstrated that CTx-1301 can be
taken with or without food. Multiple pharmacokinetic (PK)
measurements were taken and adverse events were consistent with
previous findings and indicate a favorable tolerability
profile.
“We are developing CTx-1301 to be the first
true, once-daily stimulant medication that treats ADHD over an
entire active day, and crucial to this is ensuring a
pharmacokinetic profile customized for the unique attributes of
stimulant medications and ADHD, regardless of food intake,” said
Shane J. Schaffer, PharmD, Chairman and CEO, Cingulate. “The
results of this study are instrumental in confirming that we have
identified the optimal formulation of CTx-1301, paving the way for
our Phase 3 trials.”
Cingulate recently announced the initiation of
its first Phase 3 trial for CTx-1301, an adult dose-optimization
efficacy and safety study to assess onset and duration, with
results expected in the third quarter of 2023. In addition, the
Company plans to initiate its pivotal Phase 3 trial, a fixed-dose,
placebo-controlled study in pediatric and adolescent patients with
ADHD, in mid-2023.
“CTx-1301 is being developed to provide the
proven efficacy of stimulants while addressing the key challenges
associated with available formulations, including sub-optimal onset
and duration along with burdensome medication regimens which often
lead to non-compliance, discontinuation, and abuse or diversion of
the treatment,” said Matthew Brams, MD, Chief Medical Officer,
Cingulate. “The ability to provide patients with a once-daily
treatment that has the flexibility to be taken with or without food
and delivers fast onset, a favorable tolerability profile, and
entire active-day efficacy addresses the biggest unmet needs facing
ADHD patients and providers.”
CTx-1301 Pharmacokinetics in Both Fed
and Fasted StatesIn CTx-1301-003 (NCT04449250), 23 healthy
adult subjects (age range: 18 to 50 years) were randomized into one
of two sequences to receive a single 25 mg dose of CTx-1301 on two
occasions (once with a standard high fat breakfast and once on an
empty stomach). Both doses were administered with 8 oz of water and
frequent blood samples were obtained for a period of 28 hours after
each dose in order to define the absorption and elimination profile
of dexmethyphenidate (i.e. the pharmacokinetics or PK).
The primary PK endpoints of this study were the
maximum plasma concentration achieved after each dose (Cmax) as
well as the extent of dexmethylphenidate absorbed into the blood
expressed as the area the plasma drug concentration vs. time curve
(AUC). Knowledge of these two PK parameters which definine maximum
and total extent of exposure are essential for a drug’s regulatory
approval.
“The study of CTx-1301 in the fasted versus fed
state demonstrated that food did not delay absorption, and thus
should not affect onset of action. Therefore, we expect that
CTx-1301 can be administered orally with or without food, however
patients should be advised to take the medication consistently as
such," said Raul Silva, MD, Chief Science Officer, Cingulate. “What
is important is that the delivery system worked irrespective of the
presence of food intake and this study provides important clinical
knowledge for providers in the treatment of ADHD patients.”
Full results, including data on secondary
endpoints measuring half-life and time to onset, are being
submitted for presentation at a forthcoming medical meeting.
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 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 New Drug Application
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: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-118-0224
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