CBD-Based Zygel Helps With Anxiety-Related & Behavioral Symptoms In 22q11.2 Deletion Syndrome, Phase 2 Trial Reveals

Zynerba Pharmaceuticals, Inc. ZYNE presented positive long-term 38-week data from the phase 2 INSPIRE trial with Zygel in children and adolescents with 22q11.2 deletion syndrome. The data were presented in a poster at the 61^st annual meeting of the American College of Neuropsychopharmacology, being held December 4-7, 2022 in Phoenix, Arizona.

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, all five scales of the anxiety, depression and mood scale, and all five subscales of the aberrant behavior checklist – community. 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,” stated Armando Anido, chairman and CEO 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 aberrant behavior checklist – community 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 pediatric anxiety rating scale, all five subscales of the anxiety, depression and mood scale, and all five subscales of the aberrant behavior checklist – community.

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.

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Photo by Esteban Lopez on Unsplash

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