Zynerba Pharmaceuticals Receives New U.S. Patent for Treatment of Autism Spectrum Disorder with Purified Cannabidiol
February 25 2020 - 7:15AM
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for rare and near-rare neuropsychiatric disorders, today
announced that the U.S. Patent and Trademark Office has issued U.S.
Patent No. 10,568,848, titled “Treatment of Autism with
Cannabidiol” which includes claims directed to methods of treating
autism spectrum disorder (ASD) by transdermally administering, via
a gel or cream, a therapeutically effective amount of purified
cannabidiol (CBD).
This new patent, which expires in 2038, is part of
an expanding intellectual property portfolio covering the Company's
transdermal cannabidiol product candidate, Zygel™ CBD gel. This
patent follows the previously announced issuance of US Patent No.
10,314,792, titled “Treatment of Autism with Cannabidiol” which
includes claims directed to methods of treating ASD by
transdermally administering, via gel or cream, a therapeutically
effective amount of synthetic cannabidiol.
The Company has completed enrollment in the open
label Phase 2 BRIGHT study evaluating the safety, tolerability and
efficacy of Zygel for the treatment of children and adolescents
with ASD, with 37 patients enrolled. The efficacy assessments
include the Aberrant Behavior Checklist, Parent Rated Anxiety Scale
– Autism Spectrum Disorder, Autism Impact Measure, and Clinical
Global Impression – Severity and Improvement. The Company expects
to report top line data from this trial in the second quarter of
2020.
About Zynerba Pharmaceuticals, Inc. Zynerba
Pharmaceuticals is the leader in pharmaceutically-produced
transdermal cannabinoid therapies for rare and near-rare
neuropsychiatric disorders. We are committed to improving the lives
of patients and their families living with severe, chronic health
conditions including Fragile X syndrome, autism spectrum disorder,
22q11.2 deletion syndrome, and a heterogeneous group of rare and
ultra-rare epilepsies known as developmental and epileptic
encephalopathies. Learn more at www.zynerba.com and follow us on
Twitter at @ZynerbaPharma.
Cautionary Note on Forward-Looking
StatementsThis 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,” “anticipates,” “expects,” “plans,” “intends,” “may,”
“could,” “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. For example, there can be no guarantee that the
Company will obtain approval for Zygel from the U.S. Food and Drug
Administration (FDA) or foreign regulatory authorities; even if
Zygel are approved, the Company may not be able to obtain the label
claims that it is seeking from the FDA. In addition, the Company’s
cash and cash equivalents may not be sufficient to support its
operating plan for as long as anticipated. 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 success and
timing of the Company’s product development activities, studies and
clinical trials and the Company’s expectations regarding its
ability to obtain and adequately maintain sufficient intellectual
property protection for its product candidates. 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.
Investor ContactWilliam Roberts, Vice
President, Investor Relations and Corporate CommunicationsZynerba
Pharmaceuticals484.581.7489robertsw@zynerba.com
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