Zynerba Pharmaceuticals, Inc. recently reported positive top line data from its Phase 1 ascending dose study of ZYN002, the first non-psychoactive cannabinoid, formulated as a gel for transdermal delivery for patients with refractory epilepsy, Fragile X syndrome and osteoarthritis.
Cannabidiol (CBD) is the primary non-psychoactive cannabinoid in cannabis.
Treatment with ZYN002 CBD gel was well-tolerated and safe at all doses by both treatment groups. The twice-daily dose demonstrated a favorable pharmacokinetic profile with similar results seen between treatment groups. These findings will be used to establish the doses for Phase 2 trials.
The incidence of adverse events associated with treatment with ZYN002 CBD gel was similar between both groups and only included a low occurrence of gastrointestinal complaint.
There were no performance-drug related changes on the Trail Making Test that assesses psychomotor ability, visual attention, and task switching; a divided attention task; and the Paced Auditory Serial Addition Task (PASAT) to assess focused attention and working memory.
Treatment with ZYN002 did not cause impairment in cognitive functioning areas that are often impacted by drugs targeting the central nervous system. There were no changes in mood symptoms measured or deterioration of mental health.
Zynerba also reported the results as favorable and similar in all respects between treatment groups with epilepsy in the single ascending dose trial.
“We are extremely encouraged by these results from our Phase 1 multiple rising dose trial, which are consistent with the results of the single rising dose trial, and reinforce that ZYN002 CBD gel is well-tolerated across a range of doses,” said Armando Anido, chairman and CEO of Zynerba in a recent press release.
The results of the Phase 1 trials will be used to designated doses for evaluation in the Phase 2 trial ofZYN002 CBD gel in adult patients with refractory epilepsy. The baseline phase of the trial, called STAR 1, will begin dosing in 2016, Anido said.
In addition to STAR 1 in refractory epilepsy, the company is expected to begin two Phase 2 trials for ZYN002 CBD gel in osteoarthritis and Fragile X Syndrome during the second half of 2016. Top line results from all three studies in the first half of 2017.