Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for orphan neuropsychiatric disorders, announces an oral
presentation at The Society for the Study of Behavioural Phenotypes
(SSBP) 24th International Research Symposium, being held in Oslo,
Norway, September 8-10, 2022. Helen (Honey) Heussler, MBBS FRACP
MRCPCH, DM, Associate Professor, Faculty of Medicine, Child Health
Research Centre, University of Queensland, Australia, presented
data from the open-label Phase 2 INSPIRE (Assessing the
Impact of Zygel™ [Tra
nsdermal CBD
Gel] on
Pediatr
ic
Behavio
ral and
Emotional Symptoms
of 22q11.2 Deletion Syndrome) trial. A copy of Professor Heussler’s
presentation is available on the Zynerba corporate website
at www.zynerba.com/publications.
The presentation titled, “An Open-Label, Tolerability and
Efficacy Study of ZYN002 (Cannabidiol) Administered as a
Transdermal Gel to Children and Adolescents with 22q11.2 Deletion
Syndrome (INSPIRE),” includes data that suggests a positive
risk-benefit profile for Zygel in improving anxiety-related and
behavioral symptoms in children and adolescents with 22q11.2
deletion syndrome (22q). Statistically significant improvements
from baseline were seen in the Pediatric Anxiety Rating Scale
(PARS-R), the total score and all five subscales of the Anxiety,
Depression and Mood Scale (ADAMS) and all five subscales of the
Aberrant Behavior Checklist – Community (ABC-C). In addition, the
majority of patients showed clinically meaningful improvements as
demonstrated by the Clinical Global Impression – Improvement
(CGI-I). Zygel was shown to be well tolerated, and the safety
profile was consistent with previously released data from other
Zygel clinical trials. Three patients reported treatment related
adverse events which were all mild application site adverse events.
One patient discontinued treatment due to adverse events not
related to Zygel.
“The data from the Phase 2 INSPIRE trial are very encouraging,
including the significant improvement in anxiety as measured by the
clinician-rated PARS-R scale,” said Armando Anido, Chairman and
Chief Executive Officer of Zynerba. “We believe the Phase 2 data
are very encouraging and suggest the potential of Zygel for the
treatment of anxiety and behavioral symptoms in children and
adolescents with 22q, and we look forward to discussing the
regulatory path forward with the FDA.”
About Zygel
Zygel is the first and only pharmaceutically-manufactured
cannabidiol formulated as a patent-protected permeation-enhanced
clear gel, designed to provide controlled drug delivery into the
bloodstream transdermally (i.e. through the skin). Recent studies
suggest that cannabidiol may modulate the endocannabinoid system
and improve certain behavioral symptoms associated with
neuropsychiatric conditions. Zygel is an investigational drug
product in development for the potential treatment of behavioral
symptoms associated with Fragile X syndrome (FXS), 22q11.2 deletion
syndrome (22q) and autism spectrum disorder (ASD). The Company has
received orphan drug designation for cannabidiol, the active
ingredient in Zygel, from the FDA and the European Commission in
the treatment of FXS and by the FDA for the treatment of 22q.
Additionally, Zygel has been designated a Fast Track development
program for treatment of behavioral symptoms of FXS.
About 22q11.2 Deletion Syndrome (22q)
As the second most common chromosomal disorder after Down
syndrome, 22q is caused by a small missing piece of the 22nd
chromosome. The deletion occurs near the middle of the chromosome
at a location designated q11.2. It is considered a mid-line
condition, with physical symptoms including characteristic palate
abnormalities, heart defects, immune dysfunction, and esophageal /
GI issues, as well as debilitating neuropsychiatric and behavioral
challenges. Anxiety is among the most common neuropsychiatric
symptoms of 22q and researchers have found that for children with
22q, anxiety is linked to poorer adaptive behaviors such as
self-care and communication skills that affect daily life. Children
with 22q also experience social withdrawal, attention deficit
hyperactivity disorder, cognitive impairment, and autism spectrum
disorder. Later in life, they are at an increased risk of
developing mental illnesses such as schizophrenia. It is estimated
that 22q occurs in between one in 3,000 and one in 6,000 live
births, suggesting that there are approximately 83,000 people
living with 22q in the U.S.
About Zynerba Pharmaceuticals, Inc.
Zynerba Pharmaceuticals is the leader in innovative
pharmaceutically-produced transdermal cannabinoid therapies for
orphan neuropsychiatric disorders. We are committed to improving
the lives of patients and their families living with severe,
chronic health conditions including Fragile X syndrome, 22q11.2
deletion syndrome and autism spectrum disorder. 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,
the European Medicines Agency and other 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 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; and the extent to which inflation or global
instability, including political instability, may disrupt our
business operations or our financial condition. 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
Peter VozzoICR WestwickeOffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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