Medicinal cannabis company Zelira Therapeutics Ltd (ASX: ZLD) has reached an important milestone in trials to assist chronic pain sufferers reduce their dependence on opioids.
Prescription opioids for 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.
Zelira’s Managing Director, Dr Richard Hopkins, reports that the company’s Phase 1 Dose Escalation Trial in patients on long-term opioid treatment is now fully enrolled and no serious adverse events from dosing patients have been reported to date.
Dosing is expected to be completed by April 2020 with the final report to be provided by mid 2020.
The Phase I trial is evaluating the safety and tolerability of whole plant extract following single and repeated doses with escalation in 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 trail.
The trial is being undertaken at the St Vincent’s Hospital in Melbourne in conjunction with Emerald Clinics Lt in Perth who were recently engaged as a second site.
We are delighted to have achieved full enrolment, which represents a major milestone for the trial,” Dr Hopkins said.
“We’re also pleased for the opportunity to expand our partnership with Emerald Clinics by bringing them on as a second site. We have been impressed by their ability to complement the efforts of the St Vincent team by rapidly screening and enrolling eligible patients into trial.”
Dr Michael Winlo, CEO and Managing Director of Emerald Clinics said Zelira, is investing in the rigorous, product specific clinical studies required to bring cannabinoid based medical products into the mainstream where appropriate.
“Undertaking this trial validates our model of co creating evidence with our patients while providing high quality care.
“We are excited to be building upon the collaboration announced in 2019 and look forward to leveraging Real World Evidence (RWE) and traditional clinical trials to support Zelira’s strategy and ultimately improve the health and wellbeing of our patients.”