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Zynerba Pharma: Zygel Study Fails To Achieve Statistical Significance In Endpoints

Zynerba Pharmaceuticals, Inc. (ZYNE) reported top line results from the 14-week pivotal CONNECT-FX (clinical study of Cannabidiol in Children and Adolescents with Fragile X) trial. The trial assessed the efficacy and safety of Zygel CBD gel as a treatment in for behavioral symptoms of Fragile X syndrome in 212 patients. Zygel did not achieve statistical significance versus placebo in the primary endpoint of improvement in the Social Avoidance subscale of the Aberrant Behavior Checklist. Zygel also did not show statistical significance versus placebo in the three key secondary endpoints.

Based on the analysis, Zynerba intends to meet with the FDA regarding a regulatory path forward for Zygel.

Shares of Zynerba Pharma were down nearly 40% in pre-market trade on Tuesday.

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