Results have just been published from Zynerba Pharmaceuticals’s phase 3 clinical trial of Zygel™ in the Journal of Neurodevelopmental Disorders.
In this trial, 212 children and adolescents aged 3 to 17 years were given Zygel or placebo for 12 weeks. Zygel is a pharmaceutically-manufactured cannabidiol; it is a clear gel designed to deliver the drug through the skin. The study showed signs of effectiveness for a subset of participants: those patients with more than 90% methylation of the FMR1 gene, in whom gene silencing is most likely and the impact of Fragile X is often most severe.
Zynerba is now conducting a follow-on Phase 3 trial of Zygel. This trial, called RECONNECT, is currently recruiting at twenty-eight sites across the United States, Australia, and the UK. Results from RECONNECT are expected in the second half of 2023.
