Zynerba’s Phase II epilepsy trial of ZYN002 fails to meet primary endpoint
Zynerba Pharmaceuticals has reported top-line results from the Phase II STAR 1 clinical trial of ZYN002 to treat adult epilepsy patients with focal seizures.
ZYN002 is a clear, pharmaceutically produced and permeation-enhanced cannabidiol (CBD) gel currently being designed for transdermal drug delivery.
The results showed that the double-blind, multi-centre Phase II trial did not meet the primary endpoint of statistically significant decrease in focal seizures during the 12 weeks treatment period.
In the trial, 195mg and 97.5mg of ZYN002 4.2% CBD gel were evaluated in 188 subjects aged between 18 and 71 years, who have confirmed refractory epilepsy with focal seizures with or without secondary generalisation.
Conducted at 14 centres in Australia and New Zealand, the trial assessed safety, tolerability and various secondary endpoints such as change from baseline in seizure frequency and seizure-free days.
Zynerba chairman and CEO Armando Anido said: “We are continuing to evaluate this study and the ongoing STAR 2 open label study to determine next steps with ZYN002 in adult epilepsy patients with focal seizures.
“Importantly, today’s results demonstrated ZYN002 to have a very favourable safety and tolerability profile, which is an encouraging fact as we look to develop ZYN002 as a treatment for a wide range of indications.”
Subjects on the 97.5mg ZYN002 dose experienced an 18.4% median decrease in focal seizures when compared to baseline, while a 14% median decrease was experienced for the 195mg dose and 8.7% for placebo.
The results did not show any statistically significant differences between ZYN002 and placebo for any of the secondary endpoints.
Approximately 50% of the total patients in the safety database administered with ZYN002 are reported to have experienced a minimum of one treatment emergent adverse event compared to 41% on placebo.