Zynerba Pharmaceuticals Announces Positive Long-Term Data from Phase 2 INSPIRE Trial in 22q11.2 Deletion Syndrome at the Annual Meeting of the American College of Neuropsychopharmacology
December 05 2022 - 7:30AM
Zynerba Pharmaceuticals, Inc. (Nasdaq: ZYNE), the leader in
innovative pharmaceutically-produced transdermal cannabinoid
therapies for orphan neuropsychiatric disorders, presented positive
long-term 38-week data from the Phase 2 INSPIRE trial with Zygel in
children and adolescents with 22q11.2 deletion syndrome (22q). The
data were presented in a poster at the 61st Annual Meeting of the
American College of Neuropsychopharmacology, being held December
4-7, 2022 in Phoenix, Arizona. A copy of the poster is available on
the Zynerba corporate website at www.zynerba.com/publications.
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 behavioral symptoms in
children and adolescents with 22q when added to a stable standard
of care.
“The 38-week data from the Phase 2 INSPIRE trial suggest
children and adolescents with 22q who received Zygel over a longer
term continued to show improvement in anxiety-related and
behavioral symptoms,” said Armando Anido, Chairman and Chief
Executive Officer of Zynerba. “These data provide additional
support and reinforce our belief in the potential of Zygel for the
treatment of anxiety and behavioral symptoms in children and
adolescents with 22q.”
The INSPIRE trial enrolled 20 patients in the U.S. and
Australia. Seventeen of the 20 patients completed week 14 (Period
1). Patients with a ≥35% improvement in the ABC-C irritability
subscale were allowed to continue treatment for an additional 24
weeks. Thirteen patients continued treatment, with 12 patients
completing week 38 (Period 2). At the end of both Period 1 and
Period 2, statistically significant improvements from baseline were
seen in the PARS-R, all five subscales of the ADAMS, and all five
subscales of the ABC-C.
Zygel was generally well tolerated, and the safety profile was
consistent with data from previous Zygel clinical trials. Over the
38-week treatment period, three patients reported treatment-related
adverse events which were all mild application site adverse events.
Three patients experienced serious adverse events unrelated to
Zygel and one patient discontinued due to an adverse event
unrelated to Zygel.
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 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, 22q11.2
deletion syndrome and autism spectrum disorder. Learn more at
www.zynerba.com and follow us on Twitter at
@ZynerbaPharma.
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Zynerba Contact
Peter VozzoICR WestwickeOffice: 443.213.0505Cell:
443.377.4767Peter.Vozzo@Westwicke.com
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