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 successful completion
of the manufacturing transfer of its lead candidate, CTx-1301
(dexmethylphenidate), to Societal CDMO, Inc. (NASDAQ: SCTL), a
bi-coastal contract development and manufacturing organization
(CDMO) dedicated to solving complex formulation and manufacturing
challenges primarily in small molecule therapeutic development.
Cingulate announced in October 2022 the
execution of a Master Services Agreement (MSA) with Societal CDMO
to manufacture all clinical, registration and commercial batches of
Cingulate’s lead candidate, CTx-1301, a novel, investigational
treatment being developed as a true, once-daily stimulant
medication for attention deficit/hyperactivity disorder (ADHD).
“Stimulants have been used in clinical practice
for over 50 years, and subsequent formulations have grown in
complexity as companies tried to extend the efficacy of these
compounds,” said Shane J Schaffer, Chairman and CEO, Cingulate.
“With our proprietary Precision Timed Release technology, CTx-1301
is designed to deliver dexmethylphenidate at three precise,
pre-defined times throughout the day and stands to provide patients
with efficacy through the entire active day – unlike traditionally
formulated, extended-release therapies on the market today.
Cingulate is pleased to announce that with the successful transfer
of CTx-1301 manufacturing processes to Societal CDMO, we are now
ready to produce the tablet supply needed for our ongoing and
upcoming pivotal Phase 3 studies.”
As outlined in the terms of the MSA, Societal
CDMO has successfully completed the construction of a manufacturing
suite outfitted with equipment supplied by Cingulate that will
accommodate the Company’s proprietary manufacturing processes.
“After laying the groundwork and completing the
transfer of Cingulate’s proprietary manufacturing processes to our
facility in Gainsville, Georgia, we’re ready to produce the supply
of CTx-1301 needed for the Company’s Phase 3 trials and regulatory
milestones,” said David Enloe, CEO of Societal CDMO. “We are
pleased with the progress we’ve made in this partnership thus far,
particularly as it pertains to our ability to implement the new
manufacturing approach required for Cingulate’s innovative PTR
platform. With the successful transfer of these manufacturing
processes complete, we look forward to continuing to grow our
relationship with Cingulate through its multiple upcoming clinical
milestones planned for this year.”
Cingulate has completed the first cohort of its
Phase 3 adult onset and duration trial and has now initiated the
second cohort, with results expected in the third quarter of 2023.
In addition to the Phase 3 adult dose-optimization study, the
Company plans to commence its pivotal Phase 3 fixed-dose pediatric
and adolescent study in mid-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 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 NDA 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.
About Societal
CDMOSocietal CDMO (NASDAQ: SCTL) is a bi-coastal
contract development and manufacturing organization (CDMO) with
capabilities spanning pre-Investigational New Drug (IND)
development to commercial manufacturing and packaging for a wide
range of therapeutic dosage forms with a primary focus in the area
of small molecules. With an expertise in solving complex
manufacturing problems, Societal CDMO is a leading CDMO providing
therapeutic development, end-to-end regulatory support, clinical
and commercial manufacturing, aseptic fill/finish, lyophilization,
packaging and logistics services to the global pharmaceutical
market.
In addition to our experience in handling DEA
controlled substances and developing and manufacturing
modified-release dosage forms, Societal CDMO has the expertise to
deliver on our clients’ pharmaceutical development and
manufacturing projects, regardless of complexity level. We do all
of this in our best-in-class facilities, which total 145,000 square
feet, in Gainesville, Georgia and San Diego, California. Societal
CDMO: Bringing Science to Society. For more information about
Societal CDMO’s customer solutions,
visit societalcdmo.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: |
Media
Relations |
Matt KrepsDarrow Associatesmkreps@darrowir.com (214) 597-8200 |
Thomas DaltonVice President, Investor & Public Relations,
Cingulatetdalton@cingulate.com(913) 942-2301 |
Melyssa WeibleElixir Health Public
Relationsmweible@elixirhealthpr.com (201) 723-5805 |
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