Zynerba Pharmaceuticals Inc (NASDAQ:ZYNE) announced Thursday that it has initiated the Phase 2 BRIGHT study to evaluate the potency and safety of Zygel, a CBD gel, in children and adolescents aged three to 17 with Autism Spectrum Disorder (ASD), a developmental disorder that impairs the ability to communicate and interact.
Zygel was previously referred to as ZYN002, a synthetic cannabidiol (CBD), which is a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system.The company has now selected Zygel as the new brand name for ZYN002.
Devon, Pennsylvania-based Zynerba which is doing trail-blazing work pushing clinical trials for cannabis-derived treatments, expects to present top-line data from this study in the first half of 2020.
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“Autism spectrum disorder can have a devastating impact on a child and their family,” Zynerba Pharmaceuticals CEO Armando Anido said in a statement. “The medical need is significant and unmet despite high awareness and advocacy efforts.”
Anido elaborated that though there has been an “accelerating rate of diagnosis,” 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,” said Anido.“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 behavioral symptoms of ASD. We look forward to presenting topline data in the first half of 2020.”
The 14-week BRIGHT trial is an open-label multi-dose Phase 2 clinical trial designed to evaluate the potency and safety of Zygel in approximately 36 children and adolescents aged between four through 17 with ASD.
Enrolled patients will receive weight-based initial doses of 250 mg daily or 500 mg daily of Zygel. The efficacy assessments include the Aberrant Behavior Checklist, parent-rated anxiety scale for children with autism, autism impact measure, and clinical global impression severity and improvement scale.
Zynerba Pharmaceutical’s principal line of business is cannabinoid treatments delivered via the skin to treat neurological and psychiatric disorders.
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Contact Uttara Choudhury at [email protected]