Zynerba Pharmaceuticals has reported that its cannabis-based epilepsy gel ZYN002 (cannabidiol [CBD] gel) has failed to meet the primary point in a phase 2 clinical trial.
The trial dubbed as STAR 1 was held in 188 adult epilepsy patients with focal seizures across 14 sites in Australia and New Zealand.
When compared to placebo, ZYN002 during the treatment period could not show a statistically significant decrease in focal seizures in comparison to the baseline period for either the high or low dose cohorts.
STAR expands to Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy.
The patients in the phase 2 trial were randomized to be treated during a 12-week period for every 12 hours with either 195mg of ZYN002 4.2% CBD gel, 97.5mg of ZYN002 4.2% CBD gel or placebo gel.
The primary endpoint measured the median percentage change in seizure frequency during the treatment period for 12 weeks in comparison to the 8-week baseline period.
Patients subjected to low dosage of Zynerba’s gel achieved 18.4% median reduction in focal seizures while patients of high dose of it achieved 14.0%. Zynerba said that the figures were not statistically significant to the 8.7% median reduction in focal seizures achieved by the placebo gel.
Zynerba’s epilepsy gel also failed to achieve any statistically significant differences for the trial’s secondary endpoints when compared to the placebo gel.
ZYN002 though was demonstrated to be very well tolerated among the patient population in the STAR 1 trial with its safety profile in line with previous data collected from the phase 1 trials.
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.
Anido concluded that the favorable safety and tolerability profile shown by ZYN002 was encouraging at a time when it is being developed into a treatment for a wide range of indications.
Image: Zynerba epilepsy gel ZYN002 did not meet primary endpoint in STAR 1 trial. Photo: courtesy of jk1991/FreeDigitalPhotos.net.