Zynerba Pharmaceuticals Receives New U.S. Patent for Treatment of Fragile X Syndrome with Transdermal Cannabidiol
November 12 2019 - 7:00AM
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 US
Patent No. 10,471,022, titled “Treatment of Fragile X Syndrome with
Cannabidiol” which includes claims directed to a method of treating
Fragile X syndrome, comprising transdermally administering 250 mg
or 500 mg of cannabidiol (CBD) daily via a gel or cream.
This new patent, which expires in 2038, is part
of an expanding intellectual property portfolio covering the
Company's transdermal CBD product candidate, Zygel™ (ZYN002 CBD
gel).
Zygel is currently being studied in CONNECT-FX,
a pivotal, multi-national, randomized, double blind,
placebo-controlled study evaluating the efficacy and safety of
Zygel in 204 three through 17-year old FXS patients with full
mutation of the FMR1 gene. The primary endpoint is the change from
baseline to the end of the treatment period in the Aberrant
Behavior Checklist-Community FXS Specific (ABC-CFXS) Social
Avoidance subscale. Patients who have completed the double-blind
phase are now enrolling into the 12-month open label phase. The
Company expects to report top line data in the first half 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 ZYN002 from the U.S. Food and Drug
Administration (FDA) or foreign regulatory authorities; even if
ZYN002 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 Pharmaceuticals484.581.7489
robertsw@zynerba.com
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