Quinn, an ~18 month old boy with autism, obsessively stacking cans. Credit: Copyright (c) 2003 by Nancy J Price (aka Mom).

Zynerba Pharmaceuticals has initiated a Phase II clinical trial of its cannabinoid (CBD) gel Zygel (ZYN002) for the treatment of children and adolescents with autism spectrum disorder (ASD).

Zygel is a pharmaceutically-manufactured CBD available as a permeation-enhanced clear gel formulation. It is intended for controlled, transdermal drug delivery into the bloodstream.

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Prior studies indicate that autism could be related to a disruption in the endocannabinoid (EC) system. Other research suggests CBD may modify the EC system and improve some core social and behavioural symptoms associated with autism.

The open-label, multi-dose Phase II BRIGHT trial will investigate the safety, tolerability and efficacy of Zygel in around 36 ASD patients aged four to 17.

“Though there has been an accelerating rate of diagnosis, to date there are only two FDA approved products indicated for the treatment of ASD symptoms.”

Participants will be administered with weight-based initial daily doses of 250mg or 500mg.

The efficacy assessments will be conducted using the Aberrant Behavior Checklist, Parent Rated Anxiety Scale – Autism Spectrum Disorder, Autism Impact Measure and Clinical Global Impression – Severity and Improvement.

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Top-line results from the BRIGHT trial are expected to be available in the first half of next year.

Zynerba Pharmaceuticals chairman and CEO Armando Anido said: “Though there has been an accelerating rate of diagnosis, to date there are only two FDA approved products indicated for the treatment of ASD symptoms. Both have significant side effect profiles, and neither have been approved to address the key symptoms of social impairment and anxiety.

“We are excited to initiate the BRIGHT trial evaluating the role of Zygel in ASD and are hopeful that Zygel may improve some of the core social and behavioural symptoms of ASD.”

The company started a pivotal trial of ZYN002 in patients with Fragile X syndrome (FXS) in July last year.