Zynerba Pharmaceuticals has found positive data in the newly completed Phase ll Synthetic Transdermal Cannabidiol for the Treatment of Epilepsy 1 (STAR 1) study that evaluates the effects of ZYN002 in patients with focal seizures.
The company has also unveiled the results of ongoing STAR 2 18-month open-label extension study of ZYN002 for the treatment of focal seizures.
The findings cover data through nine months of total exposure to ZYN002 and have shown that clinically meaningful responses to the gel measured by reductions in focal seizures from the baseline period of STAR 1 are correlated with continued treatment with ZYN002.
Patients who received ZYN002 for a total of nine months achieved an average reduction in seizures of 65%. Dosages included 195mg during STAR 1 for three months and 390mg for six months in STAR 2.
However, patients who received the formulation achieved a 48% median reduction in seizures from baseline. These dosages featured 390mg for three months in STAR 1 and six months in STAR 2.
Furthermore, ZYN002 was found to be well-tolerated during the nine months of exposure to ZYN002.
A total of 188 patients were enrolled for STAR 1, while 186 were analysed for efficacy, as well as 174 completed the 12-week STAR 1 study and 171 patients continued into the STAR 2 study.
Zynerba Pharmaceuticals president Terri Browning Sebree said: “These new ZYN002 data are the first of their kind, showing that focal seizures in adults may be effectively treated by a transdermal gel delivery of pharmaceutically produced cannabidiol.
“In this population of patients, continued treatment with ZYN002 was shown to significantly reduce seizure rates compared to baseline. Importantly, baseline seizure frequency appears to be an important indicator of response.
“These are important findings that will help us finalise a new trial design. We expect to outline the design, size, and timing of the trial in the first quarter of 2018, and initiate the trial later in 2018.”
Zynerba has been developing ZYN002 as a cannabidiol (CBD) transdermal gel for focal seizures.