Zelira Therapeutics Ltd (ASX:ZLD) shares are trading 25% higher intra-day after achieving a world-first clinical validation demonstrating that its medicinal cannabis drug works for people suffering insomnia.
This paves the way for selling into global markets from the second half of this year including in the USA.
Zelira has put its patented medicinal cannabis formulation ZLT-101, ingested sublingually, through a Phase 1b/2a clinical trial against insomnia, and seen it pass with flying colours.
Clinical evidence to prescribe ZLT-101
Zelira ex-US markets managing director Dr Richard Hopkins said: “We are delighted as these results have exceeded our expectations.
“Globally we are the first company to take a full-spectrum cannabis product and test it for efficacy in the insomnia space.
“Not only do the results mean that Zelira can launch a product for insomnia, the data and the clinical validation from the trial mean that doctors can be confident in prescribing medical cannabis.
“We have given physicians the clinical evidence to prescribe this compound. There are very few cannabis products that can do that today.
“Based on the success of this trial, we’re on-track to launch our Insomnia product into global markets early in the second half of 2020 and expect to be earning revenues soon after.”
Significant improvement in key insomnia symptoms
The trial used a randomised, double-blind, cross-over design where patients were treated for 14 nights with ZTL101 and 14 nights with placebo, separated by a one-week washout period.
To qualify for the trial the patients had to be suffering clinically diagnosed chronic insomnia: this means that they displayed characteristic symptoms of chronic insomnia, which include difficulty falling asleep, and/or in staying asleep on a long-term basis.
ZTL-101 treatment was shown to be safe, as measured by participants reporting only minor adverse events.
These included dry mouth and headache with 96% of symptoms resolving by the next morning. In addition, patients tolerated the maximal dose well.
In terms of efficacy, results showed that ZTL-101 treatment significantly improved key insomnia symptoms.
Treated patients showed 26% improvement in their Insomnia Severity Index (ISI) scores – a current standard for measuring the effectiveness of insomnia treatments – while patients on the highest dose achieved a 36% improvement in symptoms.
Analysis of secondary endpoints showed treated patients slept significantly longer, went to sleep faster and went back to sleep sooner after waking.
Patients also reported significant improvement in quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.
“Novel treatment for chronic insomnia”
The Principal Investigator for the study, Professor Peter Eastwood, Director at the Centre for Sleep Science at UWA, said the study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat chronic insomnia.
He added: “The fact that ZLT-101 treatment achieved statistically significant, dose-responsive improvements across a broad range of key insomnia indices is impressive.
“And the significant improvement in subjective sleep quality and feelings of waking up rested as reported by participants was particularly notable.
“Positive patient experiences are critical to the success of any insomnia drug and highlights the potential for ZLT101 to address a key area of unmet need.
“Taken together, these results are comparable to other approved insomnia therapies at a similar stage of development and suggests that ZLT-101 can be developed as a novel treatment for chronic insomnia.”
These positive results add ZLT-101 to the portfolio of Zelira products being commercialised including the recently launched HOPE range, in global markets including the US, Australia, Germany and the UK.
The company is also undertaking further human clinical trials for autism and opioid reduction and is on-track to bring additional products for aged care (Parkinson’s) and oral-healthcare to market later in 2020.