Zelda Therapeutics Ltd (ASX:ZLD) has been granted approval for its Phase I Opioid Reduction trial by the Ethics and Governance Committees at St Vincent's Hospital in Melbourne with the trial now underway.
This trial will evaluate the safety and tolerability of whole plant extract following single and repeated doses in nine patients with chronic non-cancer pain on long-term opioid analgesia.
Secondary outcomes include pharmacokinetics and the effects on pain, mood, sleep and opioid use over the duration of the trial.
The outcomes of the trial will inform a subsequent larger scale phase II study that will assess the impact of oral whole plant extract on patient ability to tolerate a stepped opioid tapering protocol.
Zelda managing director Richard Hopkins said he was delighted to have the trial underway.
He said: “To our knowledge this is the first clinical trial to be designed with a primary end point assessing the efficacy of a full spectrum plant derived cannabis formulation containing THC and CBD to reduce opioid dependence in chronic non cancer patients.
“If successful, the outcome of these trials will likely have immediate impact in major global markets where opioid overuse and addiction is a major problem.”
Shares were up almost 10% in early trade to 4.6 cents.
READ: Zelda Therapeutics to use Federal Government R&D tax rebate of 769,000 to drive clinical trials
Prescription opioids treating chronic pain are linked to serious side effects including physical dependence, which is an acknowledged growing global crisis.
In the United States an estimated 49,000 people died from opioid overdose in 2017.
In May Hopkins updated investors at Proactive’s CEO Sessions in Sydney and Melbourne on its position to service a rapidly growing global market.
He said the company was building a portfolio of clinically validated assets which presented multiple revenue opportunities to license and generate milestone and royalty payments.
This strategy is well advanced because the company has a singular focus on clinical validation to address key unmet needs.
Zelda also obtained $769,000 under the Federal Government's R&D Tax Incentive Scheme in order to accelerate clinical trials and a pre-clinical program.