Cannabis medicines validation specialist Zelira Therapeutics Ltd (ASX:ZLD) has received the final clinical report for its Phase 1 dose escalation trial in chronic pain patients on long-term high-dose opioid treatment.
The phase 1 dose-escalation trial was designed to assess the safety of Zelira’s cannabis formulation (ZTL- 103) in chronic pain patients already on long-term high-dose opioid treatment.
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.
The study was undertaken at the St Vincent’s Hospital in Melbourne in conjunction with Emerald Clinics Ltd in Perth who were engaged as a second site.
The trial was led by coordinating principal investigator Associate Professor Yvonne Bonomo for St Vincents and Associate Professor Alistair Vickery for Emerald Clinics.
Nine patients were enrolled and seven patients completed the study. The mean age was 58 years and mean oral Morphine Equivalent Daily Dose (oMEDD) was 93mg per day. Participants had a range of physical comorbidities and polypharmacy.
Associate Professor Yvonne Bonomo, Coordinating Principal Investigator for the study, and Director of the Department of Addiction Medicine, St Vincent’s Hospital Melbourne said the trial showed that ZTL- 103 treatment was safe and well-tolerated in patients diagnosed with chronic pain who were also taking high oMEDD doses.
“This is an encouraging outcome given that treatment of chronic patients is often complicated by the number of different concurrent medications they can be taking to treat a range of underlying conditions.
“We were also pleased to observe positive efficacy signals for patient-reported pain, stress, anxiety and depression following treatment, which are all measures that impact patient well-being.
These results would certainly warrant further clinical investigation to assess the ability of ZTL-103 therapy to reduce opioid dependence and improve pain and quality of life in chronic pain patients.”
Dr Richard Hopkins, Zelira’s Managing Director ex-US markets said the outcome to this trial consolidated the company’s strategic interests in the large market for chronic pain therapies.
“In terms of next steps, these trial results are already informing the design of the trial we will be undertaking with Levin Growing targeting retired athletes with chronic pain.
The data will also accelerate plans to expand Zelira’s portfolio of chronic pain products, supported by clinical trial data, we will be launching into global markets and progressing into clinical development.
“These include an aged-care product that is on-track to launch in the US later this year and a larger chronic pain clinical trial we’re planning for 2021.”