Zelira Therapeutics (ASX:ZLD) confirms ZTL-103 is safe and well-tolerated

• Zelira Therapeutics (ZLD) has confirmed its phase one dose-escalation trial of ZTL-103 has successfully met clinical endpoints for safety and efficacy
• The cannabis formulation was given to chronic pain patients who were already taking high doses of opioids
• ZTL-103 proved to be well-tolerated with no serious adverse events
• Notably, patients reported an improvement with pain, stress, anxiety and depression
• Zelira will use the data to expand its portfolio and inform a future trial which will treat retired athletes with chronic pain
• Company shares are up 3.64 per cent and are trading for 5.7 cents each

Zelira Therapeutics (ZLD) has confirmed its phase one dose-escalation trial of ZTL-103 has successfully met its primary and secondary endpoints for safety and efficacy.

The trial

The study was conducted at the St Vincent’s Hospital in Melbourne, as well as Emerald Clinics (EMD) in Perth.

This trial aimed to assess the safety of Zelira’s cannabis formulation, ZTL-103, in patients with chronic pain who are already on long-term, high-dose opioid treatment.

The downside of prescription opioid treatment is the links to serious side effects including physical dependence. In the U.S., an estimated 49,000 people died from an opioid overdose in 2017.

Nine patients were enrolled and seven completed the study. The average patient age was 58 years and the average Morphine Equivalent Daily Dose (oMEDD) was 93 milligrams per day.

Patients were treated with a single dose of ZTL-103, containing five milligrams of total cannabinoids (2.5 milligrams THC and 2.5 milligrams CBD) on the first day. After seven days, patients received another single dose of the same amount.

They then continued to take two daily doses of five milligrams for seven days before escalating to 20 milligrams per day for seven days.

Following this, the dosage increased to 30 milligrams for another seven days before taking a single dose of 25 milligrams of total cannabinoids.

The results

Primary endpoints achieved

ZTL-103 has been confirmed as safe with no reports of serious adversity and the maximal dose was generally well tolerated.

Secondary endpoints achieved

ZTL-103 reportedly improved the patient’s measure of pain. The patient’s pain was assessed using a Brief Pain Inventory (BPI) questionnaire. The BPI measures pain severity and pain interference, which is how pain generally impacts daily function and activities.

The results showed patients were dose-responsive and a significant reduction at daily doses of over 10 milligrams of total cannabinoids.

Results also showed patients’ anxiety, stress and depression was reduced at daily doses of more than 30 milligrams. Overall, the ZTL-103 treatment reduced median scores from severe or moderate to mild or normal at over 10 milligrams.

“This trial showed that ZTL103 treatment was safe and well-tolerated in patients diagnosed with chronic pain who were also taking high oMEDD doses,” Associate Professor Yvonne Bonomo said.

“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,” Yvonne added.

Outlook

The trial results have helped to inform the testing with privately-held medicinal cannabis company, Levin Growing, which will target retired athletes experiencing 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,” Managing Director Dr Richard Hopkins said.

The chronic pain products include an aged-care product that is on track to be launched in the U.S. later this year.

Company shares are up 3.64 per cent and are trading for 5.7 cents each at 10:23 am AEST.