Zygel™ (ZYN002) achieved statistically significant and clinically meaningful improvements from baseline in multiple efficacy assessments and was generally well-tolerated through 38 weeks of treatment in INSPIRE, a Phase 2 trial with Zygel in children and adolescents with 22q11.2 deletion syndrome (22q)
DEVON, Pa., Sept. 14, 2023 (GLOBE NEWSWIRE) — 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) 25th International Research Symposium, being held virtually September 14-15, 2023. Helen (Honey) Heussler, MBBS FRACP, DM, Associate Professor, Faculty of Medicine, Child Health Research Centre, University of Queensland, Australia, will present data from the open-label Phase 2 INSPIRE trial. A copy of the presentation will be available on the Zynerba corporate website at www.zynerba.com/publications.
The presentation titled, “An Open-label Trial Assessing Short- and Long-term Tolerability and Efficacy of ZYN002 (Cannabidiol) Administered as a Transdermal Gel to Children and Adolescents with 22q11.2 Deletion Syndrome (INSPIRE),” includes data demonstrating that through 38-weeks of treatment, statistically significant improvements (p<0.05) 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. In addition, caregivers for patients in the study reported improvement in the most impactful self-identified behavioral, emotional or social problems during the 38-week treatment period. Zygel was shown to be generally 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 in severity and application site related. One patient discontinued treatment due to adverse events not related to Zygel.
“Anxiety and behavioral symptoms have significant impact on the lives of individuals with 22q, and these findings are encouraging and warrant further study of Zygel in a controlled trial to confirm these results,” said Professor Heussler.
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.
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