Zynerba Pharmaceuticals, Inc. is presenting two posters at the 55th Gatlinburg Conference, being held April 10-13, 2023, in Kansas City, Mo. 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). Additionally, Zygel has been designated a Fast Track development program for treatment of behavioral symptoms of FXS.

RECONNECT is a Phase 3 trial of Zygel in patients with FXS ages 3 through 22 years. The trial was designed based upon learnings from the initial Phase 3 trial, CONNECT-FX, which demonstrated potential effectiveness of Zygel in patients with 100% methylation of their FMR1 gene. RECONNECT is actively enrolling participants 3 through 22 years of age.

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.