Zynerba Pharmaceuticals reports 38-week long-term 38-Week treatment of children and adolescents with 22q/11.2 deletion syndrome

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Zynerba Pharmaceuticals reports 38-week long-term 38-Week treatment of children and adolescents with 22q/11.2 deletion syndrome

Zynerba Pharmaceuticals, Inc. ZYNE presented positive long-term 38 week data from the phase 2 INSPIRE trial with Zygel in children and adolescents with 22 q 11.2 deletion syndrome. The data was displayed in a poster at the 61st annual meeting of the American College of Neuropsychopharmacology, which was held in Phoenix, Arizona on December 4 - 7, 2022.

The poster, titled, An open-label tolerability and efficacy study of ZYN 002 cannabidiol administered as a transdermal gel to children and adolescents with 22 q 11.2 deletion syndrome INSPIRE, shows that statistically significant improvements were seen in all five scales of the anxiety, depression and mood scale, and all five subscales of the aberrant behavior checklist community over 38 weeks of treatment. The 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 22 q when added to a stable standard of care.

The 38 week data from the phase 2 INSPIRE trial shows that children and adolescents with 22 q who received Zygel over a longer term continued to show improvement in anxiety-related and behavioral symptoms, said 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 22 q. 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 community irritability subscale were allowed to continue treatment for an additional 24 weeks. Thirteen patients continued treatment, with 12 patients completed 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. Three patients reported treatment-related adverse events over the 38 week treatment period, all mild application site adverse events. Three patients had serious adverse events that were unrelated to Zygel and one patient was discontinued because of an adverse event that was unrelated to Zygel.

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