Zynerba Pharmaceuticals (NASDAQ:ZYNE) Inc has said it will deliver oral and poster presentations on its CBD gel Zygel at the American Society of Clinical Psychopharmacology Annual Meeting (ASCP 2022), held this week in Scottsdale, Arizona.
The oral presentation will focus on the demonstrated long-term safety and potential effectiveness of Zygel in children and adolescents with Fragile X syndrome, and the poster presentation will highlight design enhancements incorporated into its RECONNECT trial, the company said.
“The RECONNECT trial provides us with an opportunity to confirm the positive results observed in a population of responders in our CONNECT-FX trial and further evaluate the effect of Zygel on behaviors associated with Fragile X syndrome,” the company's CEO Armando Anido said in a statement.
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“Furthermore, the interim results from the open-label extension trial support the long-term safety and potential effectiveness of Zygel in children and adolescents with FXS, with the greatest improvements seen in those with complete methylation of their FMR1 gene, the population for the primary efficacy analysis in RECONNECT,” he added.
The oral presentation titled, “Long-Term Safety and Sustained Efficacy of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome (ZYN2-CL-017),” shows that in the ongoing long-term safety and efficacy trial of Zygel in children and adolescents with FXS, improvement was seen in social avoidance in the full population, with the greatest improvement in patients with complete methylation of their FMR1 gene.
Patients with complete methylation, who match the primary efficacy population in the ongoing confirmatory trial, RECONNECT, achieved and maintained clinically meaningful change in Social avoidance, which Zynerba says supports one of the key design enhancements for RECONNECT. Zygel was also well-tolerated with long-term administration with up to 38 months of exposure.
The poster titled, “RECONNECT (ZYN2-CL-033): Design of a Phase 3 Trial of ZYN002 Cannabidiol Transdermal Gel in Children and Adolescents with Fragile X Syndrome Based Upon Learnings from CONNECT-FX (ZYN2-CL-016) Completed During SARS-COV-2 Pandemic,” describes how learnings from CONNECT-FX, the first randomized, double-blind, placebo-controlled trial of Zygel in the treatment of FXS, shaped the design of RECONNECT.
In addition to the primary endpoint of the RECONNECT trial being measured in patients who have a completely methylated FMR1 gene, the treatment period of the trial has been extended by four weeks and an additional weight-based dose has been added for participants weighing greater than 50kg, the company noted.
Zynerba expects RECONNECT to provide key data to determine the effectiveness of Zygel in FXS while using a design intended to reduce the burden of participation in a clinical trial for families with children and adolescents with FXS.
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