Zynerba Pharmaceuticals Initiates ZYN001 Phase 1 Clinical Program
June 26 2017 - 7:30AM
Phase 1 results will inform potential Phase 2
studies in patients with fibromyalgia and neuropathic pain, planned
to start in 2H17
Zynerba Pharmaceuticals, Inc. (NASDAQ:ZYNE), a clinical-stage
specialty pharmaceutical company dedicated to developing and
commercializing innovative transdermal synthetic cannabinoid
treatments, today announced that it has initiated its ZYN001 Phase
1 clinical program to study the company’s patent-protected,
pro-drug of tetrahydrocannabinol (THC) delivered via a transdermal
patch. This study will assess single and multiple rising doses of
several formulations of ZYN001 to identify the optimal dose to take
into Phase 2 studies.
“The initiation of the ZYN001 clinical program
is an important milestone for the Company, as we now have two
clinical stage assets which upon approval may address serious unmet
medical needs in a variety of disease settings,” said Armando
Anido, Chairman and Chief Executive Officer of Zynerba. “We believe
that ZYN001 will be important in a number of pain indications,
given THC’s known impact on pain transmission and analgesic effect
in patients suffering from chronic pain. Our state-of-the-art
transdermal patch delivery offers unique advantages to patients,
including the potential for more consistent, sustained delivery and
better tolerability of THC.”
This first in man study is a randomized,
double-blind, placebo-controlled Phase 1 trial. First, the safety,
tolerability and pharmacokinetic profile of a single dose of ZYN001
versus placebo will be evaluated. Several formulations and patch
wear times ranging from 24 hours to 7 days will be assessed in up
to 48 healthy subjects. Based on results from the single dose
portion of this trial, two formulations will be evaluated in
multiple patch applications for 14 days in up to 32 healthy
subjects who will be randomized 3:1 to ZYN001 or placebo. The goal
is to deliver constant levels of THC to optimize efficacy while
minimizing CNS side effects. With the successful completion of this
single and multiple dose study, a Phase 2 program for ZYN001 in
fibromyalgia and neuropathic pain is planned to start in the second
half of 2017.
About ZYN001 THC Pro-Drug
PatchZYN001 is a synthetic pro‑drug of THC in a
state-of-the-art drug-adhesive matrix transdermal patch, and is
being developed for patients with fibromyalgia and peripheral
neuropathic pain. THC is a CB1 agonist which acts at many sites
along pain transmission pathways, and has been shown to have an
analgesic effect in chronic pain models. A pro‑drug is a drug
administered in an inactive or less active form and designed to
enable more effective delivery, which is then converted into an
active form through a normal metabolic process. Transdermal
patches allow drugs to be absorbed through the skin directly into
the systemic blood circulation, avoiding first-pass liver
metabolism and potentially enabling lower dosage levels of active
pharmaceutical ingredients, a more controlled, consistent delivery
of drug with a higher bioavailability and potentially lower
incidence of CNS side effects.
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 March 2017, the Company completed
enrollment in 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. Also in March 2017, 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 fully enrolled. In June 2017, the Company
completed target enrollment in its exploratory Phase 2 FAB-C
(Treatment of Fragile X Syndrome Anxiety and Behavioral Challenges
with CBD) clinical trial in children with Fragile X syndrome.
Zynerba is also developing ZYN001, which utilizes a synthetically
manufactured pro-drug of THC. A Phase 1 clinical study for ZYN001
was initiated in the second quarter 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. 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 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. 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.
Zynerba Contacts
Jim Fickenscher, CFO and VP Corporate Development
484.581.7483
fickenscherj@zynerba.com
Will Roberts, VP Investor Relations and Corporate Communications
484.581.7489
robertsw@zynerba.com
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