Cingulate Provides 2022 Clinical Plan for CTx-1301, an Investigational Medication for Attention Deficit/Hyperactivity Disorder (ADHD)
February 08 2022 - 6:45AM
Cingulate Inc. (NASDAQ: CING), a clinical-stage 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 updates
to its 2022 clinical program for its lead candidate CTx-1301, an
investigational asset for the treatment of Attention
Deficit/Hyperactivity Disorder (ADHD).
This year, the Company plans to initiate its
CTx-1301 Phase 3 clinical studies: a fixed-dose pediatric and
adolescent safety and efficacy study, a dose-optimization study
extension, and a pediatric safety and efficacy study to assess the
onset and duration of efficacy. Specifically, the pivotal,
fixed-dose study is slated to begin in the second quarter of 2022.
These studies will be conducted in the United States (U.S.) and are
instrumental for the filing of the New Drug Application to the U.S.
Food and Drug Administration (FDA), expected in the second half of
2023.
Based on feedback from the FDA regarding the
CTx-1301 initial Pediatric Study Plan (iPSP), and longstanding
guidance on the 505(b)(2) pathway, Cingulate has accelerated its
study timeline, with a strong likelihood of reducing capital
requirements by condensing the number and design of studies,
therefore potentially reducing its time to approval.
“We are determined to bring our lead candidate, CTx-1301, to
market as efficiently as possible, within the FDA regulatory
pathway for a 505(b)(2) drug. The expedited timeline of our
clinical trials will allow us to commercialize our products more
quickly, addressing the significant unmet needs in the ADHD market,
and ultimately improving patient outcomes,” said Shane J. Schaffer,
Cingulate Chairman and Chief Executive Officer. “These studies
allow Cingulate to compile a robust data set for our FDA filing,
providing clinicians and payers clear evidence of the potential
benefits of CTx-1301.”
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 Cingulate®Cingulate Inc.
(NASDAQ: CING), is a clinical-stage biopharmaceutical company
utilizing its proprietary Precision Timed Release™ (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
Attention Deficit/Hyperactivity Disorder (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 prospectus filed with the SEC on
December 9, 2021. 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 Head of Investor & Public Relations, Cingulate,
Inc.TDalton@cingulate.com913-942-2301
Andy Brimmer / Amy FengJoele Frank, Wilkinson
Brimmer Katcherabrimmer@joelefrank.com afeng@joelefrank.com
212-355-4449
Media RelationsMelyssa
WeibleElixir Health Public
Relationsmweible@elixirhealthpr.com201-723-5805
CING-US-102-0223R
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