Zynerba Pharmaceuticals Presents Data on Zygel™ at the 55th Gatlinburg Conference
April 12 2023 - 7:30AM
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for orphan neuropsychiatric disorders, is presenting two
posters at the 55th Gatlinburg Conference, being held April 10-13,
2023, in Kansas City, Mo. Copies of the posters are available on
the Zynerba corporate website at www.zynerba.com/publications.
“New interim results from the open-label extension trial
continue to support the long-term safety and sustained
effectiveness of Zygel in children and adolescents with Fragile X
syndrome (FXS), with the greatest improvements seen in those with
complete methylation of their FMR1 gene, the population for the
primary efficacy analysis in our pivotal RECONNECT trial,” said
Armando Anido, Chairman and Chief Executive Officer of Zynerba. “In
addition, we believe data from the Phase 2 INSPIRE trial suggest
the potential of Zygel as a treatment of anxiety and other
behavioral symptoms in children and adolescents with 22q.”
The presentation titled, “Long-term Safety and Sustained
Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and
Adolescents with Fragile X Syndrome (ZYN2-CL-017),” includes data
demonstrating that in the ongoing long-term safety and efficacy
trial of Zygel in children and adolescents with FXS, Zygel was
well-tolerated with long-term administration with up to 45 months
of exposure. Patients with complete methylation, who match the
primary efficacy population in the ongoing confirmatory trial,
RECONNECT, achieved and maintained clinically meaningful changes in
Social Avoidance over 24 months, further supporting this design
enhancement for RECONNECT.
The poster 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),”
shows that through 38-weeks of treatment, statistically significant
improvements were seen in children and adolescents treated with
Zygel in the Pediatric Anxiety Rating Scale (PARS-R), all five
scales of the Anxiety, Depression and Mood Scale (ADAMS), and all
five subscales of the Aberrant Behavior Checklist – Community
(ABC-C). These results are consistent with the previously reported
14-week treatment data suggesting a positive risk-benefit profile
for Zygel in improving anxiety-related and other behavioral
symptoms in children and adolescents with 22q when added to
standard of care.
About RECONNECT
RECONNECT is a Phase 3 trial of Zygel in patients with FXS ages
3 through 22 years. The trial was designed based upon learnings
from the initial Phase 3 trial, CONNECT-FX, which demonstrated
potential effectiveness of Zygel in patients with 100% methylation
of their FMR1 gene. RECONNECT is actively enrolling participants 3
through 22 years of age. More information about the trial,
including how to be contacted regarding potential participation, is
available at www.fragilexhelp.com.
About Zygel
Zygel is the first and only pharmaceutically-manufactured
cannabidiol formulated as a patent-protected permeation-enhanced
clear gel, designed to provide consistent 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) and 22q11.2
deletion syndrome (22q). 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 the
treatment of 22q. Additionally, Zygel has been designated a Fast
Track development program for treatment of behavioral symptoms of
FXS.
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 and 22q11.2
deletion syndrome. 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,”
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“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
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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
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instability, including political instability, may disrupt our
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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
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Zynerba Contacts
Peter VozzoICR WestwickeOffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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