The study, called CONNECT-FX, is designed to test the safety and efficacy of Zygel in children and adolescents with the genetic condition. Zynerba plans to move forward with the 14-week trial at clinical sites in the US, Australia and New Zealand, now with more than 200 patients enrolled.
“This is an important milestone for patients with Fragile X syndrome and their caregivers as we move toward completion of enrollment in this pivotal trial,” CEO Armando Anido said in a statement. “Through strict entry criteria and overall trial design, we expect to enhance the study’s ability to demonstrate a strong signal of activity and minimize response variability.”
The study will evaluate Zygel in the pediatric patients by using measurements such as the Fragile X Aberrant Behavior Checklist.
Top-line results are expected later this year, and if they’re positive, Zynerba expects to meet with the US Food and Drug Administration to submit a New Drug Application. If all goes according to plan, Zygel could be approved to treat Fragile X by mid-2021.
Fragile X is a genetic condition caused by a mutation in the FMR1 gene. The mutation causes the X chromosome to appear constricted, or fragile, under a microscope, hence its name. Patients with Fragile X often have learning disabilities and other cognitive impairments.
Zygel, a patented CBD-formulated clear gel, is designed to provide controlled drug delivery into the bloodstream through the skin. Some recent studies have suggested that neuropsychiatric conditions such as Fragile X Syndrome are associated with a disruption in the endocannabinoid system, and CBD may improve certain core social and behavioral symptoms by modulating that system.
Contact Andrew Kessel at [email protected]
Follow him on Twitter @andrew_kessel
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