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 it has
executed a Master Services Agreement (MSA) with Societal CDMO, Inc.
(NASD: SCTL), a bi-coastal contract development and manufacturing
organization (CDMO) dedicated to solving complex formulation and
manufacturing challenges primarily in small molecule therapeutic
development.
With capabilities spanning pre-Investigational New Drug (IND)
development to commercial manufacturing and packaging for a wide
range of therapeutic dosage forms, Societal CDMO will manufacture
all clinical, registration, and commercial batches of Cingulate’s
lead candidate CTx-1301, an investigational medication for the
treatment of Attention Deficit / Hyperactivity Disorder (ADHD).
Societal CDMO will dedicate a specific manufacturing suite within
its Gainesville, GA facility and outfit it with proprietary
equipment supplied by Cingulate.
“Choosing the right manufacturing partner is critical to the
success of any pharmaceutical company, and we are excited for the
opportunity to work with an organization which has the capacity and
operational expertise to provide quality manufacturing at each and
every scale,” said Cingulate Chairman & CEO Shane J. Schaffer.
“As Cingulate continues to advance its mission to bring
next-generation medications to patients where standard of care
treatments fail to achieve optimal outcomes, we believe that
Societal CDMO is the right partner at the right time.”
“The work that we will conduct under this MSA
with Cingulate provides an excellent opportunity for Societal CDMO
to showcase our team’s extensive expertise in formulating and
manufacturing complex therapeutics to assist in the delivery of
innovative drugs to the patients that need them. In fact, the
innovative nature of Cingulate’s PTR technology platform dictates
that we install specialty manufacturing equipment provided by
Cingulate into a dedicated suite within our facility, demonstrating
Societal CDMO’s ability to customize solutions for the unique needs
of our individual customers,” said David Enloe, chief executive
officer of Societal CDMO. “We are pleased that Cingulate has
trusted Societal CDMO to carry out these essential activities to
support CTx-1301 at such a critical juncture on its path through
clinical development and toward commercialization.”
Clinical UpdateCingulate is preparing to
initiate a Phase 3 adult dose-optimization study later this year
for its lead candidate, CTx-1301, to assess onset and duration of
efficacy and safety in adults with ADHD. The study is expected to
commence in December 2022 and will be conducted by ADHD expert and
preeminent board-certified psychiatrist Dr. Ann Childress, MD.
“We believe the onset and duration study is a critical trial for
physicians, payers, and patients, and we are delighted that Dr. Ann
Childress will be leading this investigation,” Schaffer stated.
“She has conducted more than 180 clinical studies and has worked on
most of the major psychiatric drugs that have been approved over
the last 30 years by various major pharmaceutical companies, and we
deeply value her expertise.”
In addition, our CTx-1301 Phase 3 fixed-dose pediatric and
adolescent safety and efficacy study is now expected to commence in
mid-2023 after the final two dosage strengths for this study are
completed by Societal CDMO. Assuming we receive positive clinical
results from our Phase 3 trials and the food effect study with data
expected in December 2022, we plan to submit a New Drug Application
(NDA) to the Food and Drug Administration (FDA) in the first half
of 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), 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 with the FDA.
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 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 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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