Zelira Therapeutics Ltd's (ASX:ZLD) (OTCMKTS:ZLDAF) final clinical report for a Phase 1 dose escalation trial in chronic pain patients on long-term high-dose opioid treatment shows that the primary and secondary endpoints for safety and efficacy were met.
The study at St Vincent’s Hospital in Melbourne in conjunction with Emerald Clinics Ltd (ASX:EMD) in Perth, was conducted to assess the safety of Zelira's cannabis formulation (ZTL-103) in seven chronic pain patients already using high doses of opioids.
These patients all completed the study and were treated with a single sublingual dose of ZTL-103 containing 5 milligrams of total cannabinoids (2.5 milligrams THC and 2.5 milligrams CBD) on the first day.
After a seven-day washout, they received a 5-milligram dose at the same time as having a high-fat meal and continued to take two daily doses of 5 milligrams for seven days, before escalating to 20 milligrams per day for seven days, then up to 30 milligrams for a further seven days before taking a single dose of 25 milligrams.
The trial showed ZTL-103 is safe, with no serious adverse events reported, non-serious adverse events were mild and the maximal dose was generally well tolerated.
St Vincent's Department of Addiction Medicine director and coordinating principal investigator for the study Associate Professor Yvonne Bonomo said: “This trial showed that ZTL103 treatment was safe and well-tolerated in patients diagnosed with chronic pain who were also taking high oral Morphine Equivalent Daily Dose (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.”
Emerald Clinics medical director and principal investigator for the study Associate Professor Alistair Vickery said: “We are thrilled that our unique outpatient CRO capabilities could help support this phase 1 study and demonstrate that patients managed at home with complex chronic pain conditions and concomitant polypharmacy not only benefit from ZTL-103 but have only few minor adverse events or drug interactions.”
Secondary endpoints achieved
The treatment was also shown to improve subjective measures of pain, anxiety, stress and depression in patients.
Professor Bonomo said “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.”
“Large market for chronic pain therapies”
Prescription opioids for treating chronic pain are linked to serious side effects including physical dependence, which is an acknowledged growing global crisis.
In the US an estimated 49,000 people died from opioid overdose in 2017.
Zelira managing director ex-US markets Dr Richard Hopkins said: “We are pleased with the outcome to this trial, which consolidates our 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.”