Zynerba Pharmaceuticals Announces Issuance of New U.S. Patent for Zygel™ for the Treatment of 22q11.2 Deletion Syndrome
November 02 2022 - 7:30AM
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for orphan neuropsychiatric disorders, today announced
that the U.S. Patent and Trademark Office has issued Patent No.
11,458,109, titled “Treatment of 22q11.2 Deletion Syndrome With
Cannabidiol,” which includes claims directed to methods of treating
one or more behavioral symptoms of 22q11.2 deletion syndrome with
cannabidiol.
This new patent, which expires in 2040, is part of an expanding
international intellectual property portfolio covering the
Company’s transdermal cannabidiol product candidate, Zygel. There
are currently seven corresponding U.S. patents and one
corresponding EU patent related to methods of treating Fragile X
syndrome, 22q11.2 deletion syndrome or autism spectrum
disorder.
About Zygel
Zygel is the first and only pharmaceutically-manufactured
cannabidiol formulated as a patent-protected permeation-enhanced
clear gel, designed to provide controlled drug delivery into the
bloodstream transdermally (i.e. through the skin). Recent studies
suggest that cannabidiol may modulate the endocannabinoid system
and improve certain behavioral symptoms associated with
neuropsychiatric conditions. Zygel is an investigational drug
product in development for the potential treatment of behavioral
symptoms associated with Fragile X syndrome (FXS), 22q11.2 deletion
syndrome (22q) and autism spectrum disorder (ASD). The Company has
received orphan drug designation for cannabidiol, the active
ingredient in Zygel, from the FDA and the European Commission in
the treatment of FXS and by the FDA for the treatment of 22q.
Additionally, Zygel has been designated a Fast Track development
program for treatment of behavioral symptoms of FXS.
About 22q11.2 Deletion Syndrome (22q)
As the second most common chromosomal disorder after Down
syndrome, 22q is caused by a small missing piece of the 22nd
chromosome. The deletion occurs near the middle of the chromosome
at a location designated q11.2. It is considered a mid-line
condition, with physical symptoms including characteristic palate
abnormalities, heart defects, immune dysfunction, and esophageal /
GI issues, as well as debilitating neuropsychiatric and behavioral
challenges. Anxiety is among the most common neuropsychiatric
symptoms of 22q and researchers have found that for children with
22q, anxiety is linked to poorer adaptive behaviors such as
self-care and communication skills that affect daily life. Children
with 22q also experience withdrawn behavior, ADHD, cognitive
impairment, and autism spectrum disorder that affect communication
and social interaction. Later in life, they are at an increased
risk of developing mental illnesses such as schizophrenia. It is
estimated that 22q occurs in between one in 3,000 and one in 6,000
live births, suggesting that there are approximately 83,000 people
living with 22q in the U.S. In addition, Zynerba believes that
there are approximately 112,000 patients with 22q in the EU and
approximately 129,000 in Europe if the United Kingdom is
included.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in innovative
pharmaceutically-produced transdermal cannabinoid therapies for
orphan neuropsychiatric disorders. We are committed to improving
the lives of patients and their families living with severe,
chronic health conditions including Fragile X syndrome, 22q11.2
deletion syndrome and autism spectrum disorder. Learn more at
www.zynerba.com and follow us on Twitter at
@ZynerbaPharma.
Cautionary Note on Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. We may, in some cases, use terms such as “predicts,”
“believes,” “potential,” “proposed,” “continue,” “estimates,”
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“might,” “will,” “should” or other words that convey uncertainty of
future events or outcomes to identify these forward-looking
statements. Such statements are subject to numerous important
factors, risks and uncertainties that may cause actual events or
results to differ materially from the Company’s current
expectations. Management’s expectations and, therefore, any
forward-looking statements in this press release could also be
affected by risks and uncertainties relating to a number of other
factors, including the following: the Company’s cash and cash
equivalents may not be sufficient to support its operating plan for
as long as anticipated; the Company’s expectations, projections and
estimates regarding expenses, future revenue, capital requirements,
incentive and other tax credit eligibility, collectability and
timing, and availability of and the need for additional financing;
the Company’s ability to obtain additional funding to support its
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Company’s clinical development programs, including any delays to
such clinical trials relating to enrollment or site initiation;
clinical results for the Company’s product candidates may not be
replicated or continue to occur in additional trials and may not
otherwise support further development in a specified indication or
at all; actions or advice of the U.S. Food and Drug Administration,
the European Medicines Agency and other foreign regulatory agencies
may affect the design, initiation, timing, continuation and/or
progress of clinical trials or result in the need for additional
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manufacture and supply of the Company’s product candidates the
Company’s ability to commercialize its product candidates; the size
and growth potential of the markets for the Company’s product
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Company’s ability to develop sales and marketing capabilities,
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degree of market acceptance of the Company’s product candidates;
the Company’s expectations regarding its ability to obtain and
adequately maintain sufficient intellectual property protection for
its product candidates; the extent to which health epidemics and
other outbreaks of communicable diseases, including COVID-19, could
disrupt our operations or adversely affect our business and
financial conditions; and the extent to which inflation or global
instability, including political instability, may disrupt our
business operations or our financial condition. This list is not
exhaustive and these and other risks are described in the Company’s
periodic reports, including the annual report on Form 10-K,
quarterly reports on Form 10-Q and current reports on Form 8-K,
filed with or furnished to the Securities and Exchange Commission
and available at www.sec.gov. Any forward-looking statements that
the Company makes in this press release speak only as of the date
of this press release. The Company assumes no obligation to update
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Zynerba Contact
Peter VozzoICR WestwickeOffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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