Zynerba Pharmaceuticals Receives New U.S. Patent for Treatment of Fragile X Syndrome with Cannabidiol
February 26 2019 - 6:00AM
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. 10,213,390, titled “Treatment of Fragile X Syndrome with
Cannabidiol” which includes claims directed to methods of treating
Fragile X Syndrome by administering a therapeutically effective
amount of synthetic or purified cannabidiol.
This new patent, which expires in 2038, is part of
an expanding intellectual property portfolio covering the Company's
cannabidiol (CBD) product candidate, ZYN002 Transdermal CBD
gel.
The issuance of this patent comes as enrollment
progresses in CONNECT-FX, a pivotal, multi-national, randomized,
double blind, placebo-controlled study evaluating the efficacy
and safety of ZYN002 in 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. Clinical investigative sites are enrolling
patients in the United States, Australia, and New Zealand. 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 second half of 2019.
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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