Zynerba Pharmaceuticals has started a Phase I clinical programme to study the analgesic effects of ZYN001 for various pain associated disorders.
ZYN001 is a pro-drug of tetrahydrocannabinol (THC) delivered in a drug-adhesive matrix transdermal patch, which is expected to provide consistent and sustained delivery with better tolerability.
The randomised, double-blind, placebo-controlled Phase I trial will evaluate single and multiple increasing doses of a variety of ZYN001 formulations to determine an optimal dose for the upcoming Phase II clinical trials in patients with fibromyalgia and neuropathic pain.
Zynerba chairman and CEO Armando Anido said: “The initiation of the ZYN001 clinical programme is an important milestone for the company, as we now have two clinical stage assets, which, upon approval, may address serious unmet medical needs in a variety of disease settings.
“We believe that ZYN001 will be important in a number of pain indications, given THC’s known impact on pain transmission and analgesic effect in patients suffering from chronic pain.”
The Phase I trial will investigate the safety, tolerability and pharmacokinetic profile of a single dose of ZYN001, as well as various formulations and patch wear times ranging from 24 hours to seven days in approximately 48 healthy subjects.
Two formulations, based on data from the trial’s single dose portion, will be assessed in several patch applications over a period of 14 days in around 32 healthy subjects.
The primary objective of the trial is to deliver constant levels of THC for optimised efficacy and simultaneously reduce CNS side effects.