Zynerba Pharmaceuticals Announces Completion of Enrollment for ZYN002 in Two Phase 2 Clinical Trials for Epilepsy and Osteoar...
March 13 2017 - 7:30AM
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage
specialty pharmaceutical company dedicated to the development of
innovative transdermal synthetic cannabinoid treatments, today
announced that it has completed enrollment in the Phase 2 STAR 1
(
Synthetic
Transdermal
C
annabidiol for the T
reatment of
Epilepsy) clinical trial evaluating ZYN002 cannabidiol (CBD) gel in
adult epilepsy patients with refractory focal seizures. The Company
also announced that enrollment has completed in the Phase 2 STOP
(
Synthetic
Transdermal
Cannabidi
ol for the Treatment of Knee
Pain due to Osteoarthritis) clinical trial
evaluating ZYN002 CBD gel for the treatment of osteoarthritis.
In the double-blind, multi-center STAR 1 trial,
224 patients with refractory epilepsy were screened and the Company
expects to exceed the target of randomizing 180 patients once the
remaining patients complete the 8-week baseline period. The screen
failure rate experienced for this trial has been between 10% -
15%. The primary endpoint for the STAR 1 trial will assess
the median percentage change in seizure frequency over the 12-week
treatment period.
In the double-blind, multi-center STOP trial,
418 patients with osteoarthritis knee pain were screened and the
Company has already exceeded the target of randomizing 300
patients. Additional patients still in the baseline period
are expected to be randomized as well and the screen failure rate
experienced for this trial has been between 20% - 25%. The primary
endpoint for the STOP trial will assess the change from baseline in
the weekly mean of the 24-hour average of worst pain score.
“Reaching our target patient enrollment in the
STAR 1 and STOP Phase 2 clinical studies represents key clinical
milestones for Zynerba and we remain on-track to report
top-line data for each trial in July/August of this year,” said
Armando Anido, chairman and chief executive officer. “The rapid
enrollment and significant interest in our trials is highly
encouraging. We will continue working diligently to move these
potential treatments through clinical and regulatory development as
efficiently as possible.”
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, the most common form of
epilepsy in adults. 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
osteoarthritis was initiated. In December 2016, the Company
initiated the exploratory Phase 2 FAB-C (Treatment of Fragile X
Syndrome Anxiety and Behavioral Challenges with CBD) clinical trial
in children with Fragile X syndrome (FXS). Zynerba is also
developing ZYN001, which utilizes a synthetically manufactured
pro-drug of THC. A Phase 1 clinical study 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 Statement 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
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 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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