US-based specialty pharmaceutical firm Zynerba Pharmaceuticals has closed enrolment in the Phase II STAR 1 and Phase II STOP clinical trials of ZYN002 for the treatment of osteoarthritis and epilepsy.
ZYN002 is a synthetic cannabidiol (CBD) formulated as a patent-protected, permeation-enhanced gel.
The double-blind, multi-centre STAR 1 trial will evaluate ZYN002 in adult epilepsy patients with refractory focal seizures.
With an estimated target of 180 randomised patients, a total of 224 subjects have been screened to date.
The double-blind, multi-centre STOP trial will assess ZYN002 in patients suffering from osteoarthritis knee pain.
While 418 patients have been screened for this Phase II trial, 300 have already been randomised and it is expected that additional patients in the baseline period will also be randomised.
Zynerba chairman and chief executive officer Armando Anido said: “Reaching our target patient enrolment in the STAR 1 and STOP Phase II clinical studies represents key clinical milestones for Zynerba and we remain on-track to report top-line data for each trial in July / August of this year.
"We will continue working diligently to move these potential treatments through clinical and regulatory development as efficiently as possible.”
The Star 1 trial's primary endpoint is to assess the median percentage change in seizure frequency over the 12-week treatment period, while the STOP trial will examine the change from baseline in the weekly mean of the 24-hour average of worst pain score.
It is estimated that the top-line results from both the trials will be reported in July / August.
Image: Histopathology of osteoarthrosis of a knee joint. Photo: courtesy of Wikipedia.