Zynerba Pharmaceuticals to Highlight Data for ZYN002 CBD Gel at the 70th Annual Meeting of the American Epilepsy Society
November 28 2016 - 7:00AM
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage
specialty pharmaceutical company dedicated to the development of
innovative transdermal synthetic cannabinoid treatments, today
announced that two posters relating to ZYN002, its patent-protected
synthetic CBD gel, have been selected for presentation at the
upcoming 70th Annual Meeting of the American Epilepsy Society,
including safety, tolerability and effects on cognition and mood
changes in healthy volunteers and adult epilepsy patients with
focal seizures. The meeting will be held December 2 – 6, 2016, in
Houston, Texas.
“We are encouraged to see that data further supporting the
safety profile of ZYN002 were chosen for presentation at this
year’s Annual Meeting for the American Epilepsy Society,” said
Armando Anido, Chairman and Chief Executive Officer of Zynerba.
“These data demonstrate that ZYN002 CDB gel is safe, well-tolerated
and show no psychoactive effects across a wide range of doses.
Enrollment in our STAR 1 phase 2 clinical trial for adult
refractory epilepsy patients with focal seizures is continuing and
we remain on track to report top line results of this trial in the
first half of 2017. Earlier this month, we announced the
initiation of our STAR 2 open-label extension trial which will
support long-term safety and tolerability of ZYN002 CBD gel in this
patient population.”
Below is a list of Zynerba’s accepted posters and their
presentation times. Additional information regarding the American
Epilepsy Society and presentations at its annual meeting can be
found online at www.aesnet.org.
|
|
Poster Number |
Title of Poster and Presentation Time |
2.214 |
Safety and tolerability of ZYN002 (synthetic cannabidiol)
transdermal gel in healthy subjects: two phase 1, randomized,
double-blind, placebo-controlled studies Poster Session 2: Sunday,
December 4, 2016 from 10:00 am – 4:00 pm CTLocation: Hall A3, Level
3Presenter: Terri Sebree, Zynerba Pharmaceuticals |
3.237 |
Neuropsychological effects of ZYN002 (synthetic cannabidiol)
transdermal gel in healthy subjects: two phase 1, randomized,
double-blind, placebo-controlled studies Poster Session 3: Monday,
December 5, 2016 from 8:00 am – 2:00 pm CTLocation: Hall A3, Level
3Presenter: Marcel Bonn-Miller, University of Pennsylvania Perelman
School of Medicine |
|
|
About ZYN002 CBD GelZynerba’s ZYN002 CBD gel is
the first and only synthetic CBD formulated as a patent-protected
permeation-enhanced gel and is being studied in refractory
epilepsy, Fragile X syndrome and osteoarthritis. ZYN002 is a clear,
permeation-enhanced gel that is designed to provide consistent,
controlled drug delivery transdermally with twice-daily dosing.
Transdermal therapeutics are absorbed through the skin directly
into the systemic circulation, avoiding first-pass liver metabolism
and potentially enabling lower dosage levels of active
pharmaceutical ingredients and rapid and reliable absorption with
high bioavailability. In addition, transdermal delivery avoids the
gastrointestinal tract and potential stomach acid degradation of
CBD into THC (associated with psychoactive effects), as
demonstrated in a Zynerba-sponsored in vitro study.
About Zynerba Pharmaceuticals, Inc. Zynerba
Pharmaceuticals (NASDAQ:ZYNE) is a clinical-stage specialty
pharmaceutical company focused on developing and commercializing
proprietary next-generation synthetic cannabinoid therapeutics
formulated for transdermal delivery. Zynerba is developing
therapeutic candidates based on proprietary transdermal
technologies that, if successfully developed, may allow sustained,
consistent and controlled delivery of therapeutic levels of two
cannabinoids: cannabidiol (CBD), a non-psychoactive cannabinoid,
and tetrahydrocannabinol (THC). Transdermal delivery has the
potential to reduce adverse effects associated with oral dosing.
ZYN002, the Company’s CBD gel, is the first and only synthetic CBD
formulated as a patent protected permeation-enhanced gel. In June
2016, the company initiated the Phase 2 STAR 1 (Synthetic
Transdermal Cannabidiol for the Treatment of Epilepsy) clinical
trial of ZYN002 CBD gel in adult refractory epilepsy patients with
focal seizures and has also launched the STAR 2 open-label
extension trial which allows patients who complete STAR 1 to
receive treatment with ZYN002 gel for up to 52 weeks. In August
2016, the Phase 2 STOP (Synthetic Transdermal Cannabidiol for the
Treatment of Knee Pain due to Osteoarthritis) clinical trial in
patients with knee pain due to OA was initiated. A Phase 2 clinical
trial in Fragile X syndrome (FXS) is expected to initiate in the
second half of 2016. Zynerba is also developing ZYN001, which
utilizes a synthetically manufactured pro-drug of THC. A Phase 1
clinical trial for ZYN001 is planned to begin in the first half of
2017. Learn more at www.zynerba.com and follow the Company 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. For example,
there can be no guarantee that the Company will obtain approval for
ZYN002 or ZYN001 from the U.S. Food and Drug Administration (FDA)
or foreign regulatory authorities; even if ZYN002 or ZYN001 are
approved, the Company may not be able to obtain the label claims
that it is seeking from the FDA. 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 success, cost
and timing of the Company’s product development activities, studies
and clinical trials; the success of competing products that are or
become available; 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; and the Company’s expectations
regarding its ability to obtain and adequately maintain sufficient
intellectual property protection for its product candidates. These
and other risks are described in the Company’s periodic reports,
including the annual report on Form 10K, quarterly reports on Form
10Q 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 Contacts
Jim Fickenscher, CFO and VP, Corporate Development
Zynerba Pharmaceuticals
484.581.7483
Fickenscherj@zynerba.com
Kimberly Minarovich
Argot Partners
212.600.1902
kimberly@argotpartners.com
Media Contact
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com
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