Zynerba Pharmaceuticals Provides Update on Recent Milestones
September 14 2020 - 6:55AM
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for rare and near-rare neuropsychiatric disorders, today
provided an update on its Fragile X syndrome (FXS) and
developmental and epileptic encephalopathies (DEE) programs.
Fragile X syndrome (FXS)
Zynerba has been notified that the U.S. Food and
Drug Administration (FDA) will meet with the Company via
teleconference in the fourth quarter of 2020 to discuss the pivotal
CONNECT-FX data and the regulatory path forward in patients with
FXS and a fully methylated FMR1 gene (FMet). The Company also
expects to disclose the outcome of the meeting in the fourth
quarter of this year.
“The meeting with the FDA will be an important
milestone for patients and their families who live with the
debilitating behavioral impact of Fragile X,” said Armando Anido,
Chairman and Chief Executive Officer of Zynerba. “Our ongoing
evaluation of the pivotal CONNECT-FX data continues to clarify the
impact that Zygel achieved in the most severely impacted children
and adolescents with FXS, as well as the excellent tolerability
profile. We look forward to discussing the pivotal data and the
regulatory path for potential approval in FMet patients with the
FDA in the fourth quarter of this year.”
Zynerba also announced that the U.S. Patent and
Trademark Office has issued US Patent No. 10,758,497, titled
“Treatment of Fragile X Syndrome with Cannabidiol” which includes
claims directed to a method of treating FXS comprising
administering 250mg or 500mg of synthetic or purified cannabidiol
in a pharmaceutically acceptable carrier to a person in need
thereof. This new patent, which expires in 2038, is part of an
expanding intellectual property portfolio covering Zygel.
Developmental and epileptic
encephalopathies (DEE)
Zynerba has concluded its iterative meetings with
the FDA utilizing their ‘Written Response Only’ (WRO) format to
discuss the clinical pathway for Zygel in DEE. The FDA supports a
development program which would treat focal-impaired awareness and
convulsive seizures. However, due to the heterogeneity of patients
who fall under the DEE umbrella, the FDA suggests that Zynerba
pursue individual syndromes rather than considering DEE patients as
a single disorder or condition. The Company is in the process of
finalizing its evaluation of which epileptic syndromes it may
pursue with Zygel.
“We appreciate our partnership with the FDA, and thank them for
their input and support as we seek to advance the development of
Zygel in certain rare epilepsy syndromes,” continued Anido. “We
look forward to completing our target assessments and communicating
our path forward around the end of this year.”
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
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,”
“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. 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
clinical development programs; the results, cost and timing of the
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
and foreign regulatory agencies may affect the design, initiation,
timing, continuation and/or progress of clinical trials or result
in the need for additional clinical trials; the Company’s ability
to obtain and maintain regulatory approval for its product
candidates, and the labeling under any such approval; the Company’s
reliance on third parties to assist in conducting pre-clinical and
clinical trials for its product candidates; delays, interruptions
or failures in the 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 candidates, and the Company’s ability to service
those markets; the Company’s ability to develop sales and marketing
capabilities, whether alone or with potential future collaborators;
the rate and 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 timing and outcome of
current and future legal proceedings; and 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. 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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