Zynerba Pharmaceuticals to Present an Update on the Zygel™ Development Program

Zynerba Pharmaceuticals

DEVON, PA — Zynerba Pharmaceuticals, Inc. (NASDAQ: ZYNE), the leader in innovative pharmaceutically-produced transdermal cannabinoid therapies for rare and near-rare neuropsychiatric disorders, recently presented an overview of its Zygel™ (ZYN002) development program in Fragile X syndrome (FXS) and additional caregiver-reported data from its 14-week pivotal CONNECT-FX (Clinical study of Cannabidiol (CBD) in Children and Adolescents with Fragile X) trial during the 17th NFXF International Fragile X Conference Research Roundup.

The multi-national, randomized, double-blind, placebo-controlled trial assessed the efficacy and safety of Zygel™ CBD gel as a treatment for behavioral symptoms of Fragile X syndrome (FXS) in 212 patients; topline results were announced on June 30, 2020.

Qualitative Caregiver Reported Behavioral Survey
Figure 1. Results of Qualitative Caregiver Reported Behavioral Survey

The presentation entitled, “Zygel (ZYN002) Development Program in Fragile X Syndrome” took place yesterday, July 22, 2020. A copy of yesterday’s presentation is available on the Zynerba corporate website at http://zynerba.com/publications/.

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Caregiver Global Impression - Change from Baseline to Week 12
Figure 2. Results of Caregiver Impression – Change: Full Methylation Group

“I am very pleased [to have participated in yesterday’s] Fragile X Research Roundup on Fragile X Awareness Day,” said Joseph M. Palumbo, MD, FAPA, MACPsych, Chief Medical Officer of Zynerba.

“We believe that the caregiver data that we [presented further supports] the statistically significant improvement we achieved in the primary endpoint of social avoidance in patients with full methylation of their FMR1 gene.

“We look forward to discussing these and other data with the U.S. Food and Drug Administration as soon as possible regarding a potential regulatory path forward.”

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