Zelira Therapeutics (ASX:ZLD) has completed another medicinal cannabis trial and passed with flying colours.

This time it was a Phase 1 dose escalation study assessing the safety of its cannabis formulation in chronic pain patients using opioids as a treatment.

The study met its primary end points in being well tolerated and having no serious adverse effects.

Several secondary endpoints were also met, including improved subjective measures of anxiety, stress and depression.

Professors Yvonne Bonomo and Alistair Vickery, Principal Investigators for the study both declared the outcome was solid, specially considering that concurrent medications can often complicate additional treatments.

The trial was only a Phase 1, which primarily measures tolerance instead of whether or not it works.

 

“Absolutely what we wanted to achieve”

Zelira managing director (Ex-US) Richard Hopkins says Phase I was a critically important stage for this condition.

“What’s exciting is that, chronic pain is really tricky as an area. Patients are often complex in terms of what diseases they’re suffering from and often take a lot of different medications at the same time to manage their chronic pain,” Dr Hopkins told Stockhead.

“One of the biggest challenges for new drugs coming into this space is to establish a safety profile – [that] it works; and this is what this trial was designed to do.”

“It showed that cannabis, notwithstanding the fact that they [patients] have got a lot of what we call co–current or other diseases and they’re taking other opioid levels and other medications, it was still found to be safe.

“So it was absolutely what we wanted to achieve, it’s a very safe drug in a complex area.

“And on top of that – notwithstanding the trial was relatively small; we did see significant reductions in some efficacy markets like anxiety, depression and stress which is where we know cannabis can work pretty well.”

 

COVID-19 restrictions manageable

The result also comes amidst uncertain times for cannabis clinical trials with some being halted or cancelled as a result of COVID-19.

However, many underlying medical conditions that these trials are attempting to treat, particularly stress and anxiety, have risen amidst the pandemic.

Dr Hopkins noted that the trial concluded before COVID-19 restrictions. But it would likely have been unaffected being mostly conducted from patients’ homes.

“This trial was actually done at home. So we were able to maintain social distancing very easily and the fact the patient could then have a nurse visit them and take the medication home – it actually made the trial very easy,” he said.

“I think it [COVID-19] is a risk, it’d be wrong to say it is not. But I think we’re in a fortunate position where with these particular patients and the way we design the trials we can manage.”

Zelira shares only rose modestly this morning but have now almost doubled since bottoming out at 2.9 cents in mid-March.

ZLD share price chart

 

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