COVID-19 hasn't hurt cannabis clinical trials ... much

Since the start of March, six clinical trials involving cannabis treatments around the world have been halted or cancelled altogether due to COVID19 pandemic but 179 are still recruiting, according to the US registry ClinicalTrials.com.

More generally, hundreds of clinical trials around the world were suspended due to enrolments being halted/slowed and delayed start dates, according to data analytics service GlobalData.

Between March and May, thousands of clinical trials were paused around the world including over 700 in Australia and New Zealand.

But the small number of cannabis trials meant most were not affected. Nine cannabis trials in Australia and New Zealand are currently recruiting, according to the Australia New Zealand Clinical Trials Registry.

“Once lockdown measures start to ease, recruitment for these trials should be able to resume. If the measures do not change in the near future, companies should start to look at alternatives such as virtual or decentralised trials, if regulations allow,” said GlobalData product manager Johanna Swanson.

“The need for medicinal marijuana products may also increase due to heightened anxiety and stress. COVID-19 has placed enormous strain on the mental health of the general public.

“The crisis is causing heightened anxiety and stress, with people feeling vulnerable and struggling with worries about contracting the virus, job losses and pay cuts, on top of juggling childcare, work, isolation, and general uncertainty about the post COVID 19 future.”

Clinical trials refer to human studies for proposed drugs or medical devices that must take place in order for said to be registered with regulators. A Phase 1 study ensures the drug or device is safe, Phase 2 is to test whether it works in a small group of people, and a Phase 3 study tests a larger group of people.

Aussie trials

Seven clinical trials for cannabis treatments in Australia and New Zealand were completed this year, including Phase 1/2 trials by Medlab Clinical (ASX:MDC) into cancer pain and Zelira (ASX:ZLD) into insomnia.

Both met primary and secondary endpoints.

Botanix (ASX:BOT) on the other hand has struggled, as treatments for acne and dermatitis failed to meet the necessary thresholds to move forward.

And proving trials can be done in the face of COVID-19, AusCann (ASX:AC8) started a Phase 1 clinical trial in late April to evaluate the pharmacokinetics, or the way a drug works in the body, of a single dose of two formulations of orally administered THC/CBD combination in healthy volunteers.

Clinical trials for formulated marijuana drugs are still fairly rare.

This is because few treatments have yet emerged from the rigours of the lab, and regulations in clinical trial powerhouse the US have stymied research into the plant.

The biggest issue is that marijuana is a widely available plant so to make very expensive human trials worth it, companies need to find a patentable aspect which can be protected and therefore sold exclusively for a period of time.

Zelira, for example, has patented three different ratio formulations, one being 2:1 parts THC:CBD, in Australia. The same claims are “well advanced” in the US, according to CEO Richard Hopkins.

This will give the company potentially large market power in the future once it’s proved those formulations work for basic conditions such as anxiety and opioid reduction.

Cannabis has been touted as a treatment for COVID-19 symptoms, with companies such as Botanix releasing findings that certain compounds have an antimicrobial effect on Staphylococcus aureus and Methicillin-resistant Staphylococcus aureus, or golden Staph.

However, these claims are yet to make it out of the lab and into human trials.