Cingulate Issued European Patent for Lead Asset CTx-1301 for the Treatment of ADHD
15 Agosto 2024 - 6:45AM
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, announced today that it
was issued a European patent for its lead asset CTx-1301
(dexmethylphenidate) for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD).
The patent application was granted on August 14, 2024, as EP
Patent No. 3261625, and will include up to 30 European territories,
including the United Kingdom. In addition to the European patent,
Cingulate has patents in Australia, Canada and Israel, as well as
pending patents in Hong Kong, the Republic of Korea, and the United
States.
“The granting of this patent is another meaningful milestone as
Cingulate seeks to expand its reach beyond the United States and
make a positive impact on the growing ADHD markets in Europe and
other territories abroad. We look forward to obtaining additional
patents in the near-term as we continue to showcase the clinical
success of CTx-1301 and move closer to filing a new drug
application with the FDA,” said Cingulate Chairman and CEO Shane J.
Schaffer.
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 65-90 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.
About CTx-1301Cingulate’s lead candidate,
CTx-1301, utilizes Cingulate’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 continues to be providing patients with an 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.
About Precision Timed Release™ (PTR™) Platform
TechnologyCingulate is developing ADHD and anxiety
disorder product candidates capable of achieving true once-daily
dosing using Cingulate’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 in
addition to Anxiety and ADHD 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.
To see Cingulate’s PTR Platform,
click here.
About Cingulate®Cingulate Inc. (NASDAQ: CING),
is 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,
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
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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 April 1, 2024. 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 RelationsThomas DaltonVice President,
Investor & Public Relations,
CingulateTDalton@cingulate.com913-942-2301
Matt KrepsDarrow
Associatesmkreps@darrowir.com214-597-8200
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