Zynerba Provides Clinical Update for Lead Development Candidates – ZYN001 and ZYN002
October 17 2016 - 7:00AM
Phase 1 clinical trial for ZYN001 is expected to
begin in 1H17
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage
specialty pharmaceutical company dedicated to the development of
innovative transdermal synthetic cannabinoid treatments, today
provided a development update for ZYN001 and ZYN002.
Zynerba and its development partner, LTS LOHMANN
Therapie-Systeme AG (LTS), a market leader in transdermal
therapeutic solutions, are working together to optimize the
formulation of ZYN001 into a state of the art drug-adhesive matrix
transdermal patch. ZYN001 is a patent-protected pro-drug of THC
being developed for the treatment of fibromyalgia and peripheral
neuropathic pain. Based on the additional optimization work in
progress, Zynerba now expects to begin Phase 1 clinical trials for
ZYN001 in the first half of 2017 and Phase 2 clinical trials are
now planned to begin during the second half of 2017.
Three Phase 2 clinical trials with ZYN002, the first and only
synthetic CBD that is formulated as a patent-protected
permeation-enhanced gel, remain on track to report topline results
in the first half of 2017. Two Phase 2 clinical trials are ongoing
for ZYN002, in adults with refractory epilepsy and in knee pain
associated with osteoarthritis. Phase 2 clinical trials in patients
with Fragile X Syndrome (FXS) are on track to begin before the end
of 2016.
“We are thrilled with the progress made in our development
compounds – ZYN002 and ZYN001. Additionally, we are excited with
the tremendous progress made by LTS in transforming ZYN001 into an
optimized transdermal patch that balances efficacy with patient
convenience,” said Armando Anido, Chairman and CEO. “We have
completed the development of several prototypes which are smaller
and more patient-friendly than our original design and believe that
it is appropriate to move to this state of the art patch technology
prior to initiating clinical development.”
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 refractory epilepsy
patients with focal seizures. 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
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 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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