Zelira Therapeutics' cannabinoid-based insomnia drug ZTL-101 is showing serious potential, tapping into an annual market of USD $2 billion.
Zelira Therapeutics Ltd (ASX: ZLD), a leading global therapeutic medicinal cannabis company announced on Wednesday that it had moved one step closer to building a portfolio of clinically-validated assets by achieving the primary endpoint in the company's insomnia trials.
In Zelira's recent announcement, the company reported achieving a "statistically significant improvement in Insomnia Severity Index scores in patients diagnosed with chronic insomnia."
The Insomnia trial was randomized and double-blind, involving 24 patients suffering with chronic insomnia between the ages of 25-70. The trial occurred over 35 days, 14 of which involved the company's insomnia drug ZTL-101, and the other 14 days using a placebo, with a week "washout period" in-between.
Depending on their symptoms, patients were either given a single dose at 0.5ml, or a double dose of 1ml of the medication delivered sublingually. Just over half (23) of the patients who chose the single-dose ended up doubling their dose.
The primary endpoints in the study were the safety of the medication and the changes in insomnia symptoms as measured by the Insomnia Severity Index (ISI) at the end of each of the two 14 night periods.
On safety, the most frequently reported adverse effect was dry mouth, which comprised 22.2% of all adverse effects, as well as dizziness (16.7%), headaches (11.1%) and feelings of abnormality (11.1%). In total, 36 non-serious adverse events were recorded from 17 participants. All of these adverse effects were reported as being mild or having concluded by the morning.
The second endpoint, regarding Insomnia Severity Index Scores revealed a significant decrease following the administration of ZTL-101, but not following the administration of the placebo. The ISI scores following ZTL-101 and placebo were significantly different.
This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia. Professor Peter Eastwood, Principal Investigator for the insomnia trial
Professor Peter Eastwood, the Principal Investigator for the study and the Director at the Centre for Sleep Science at the University of Western Australia stated that "It's the first trial to use the Insomnia Severity Index, arguably the current gold standard in this field, to measure the efficacy of a medicinal cannabis product to treat insomnia symptoms. The fact that ZLT-101 treatment achieved a statistically significant improvement in ISI scores is very impressive, particularly given the relatively short two-week dosing window."
"The lack of serious adverse or persistent mild adverse events is also encouraging given the reported safety issues for several already approved insomnia therapies. Taken together, these results suggest ZLT-101 has potential as a novel treatment for Insomnia."
Dr Richard Hopkins, Managing Director ex-US markets said "We are delighted with the preliminary findings from this study. Additional analyses are on-going and we expect to release a final report, including data from a comprehensive suite of secondary endpoints, by the end of March 2020 and thereafter, subsequent scientific publications based on the positive results from this study. We would like to acknowledge the dedicated team at the UWA Sleep Centre and express our gratitude to the patients and supporting investigators/organisations who participated in the study."
Zelira reports that there are an estimated 70 million Americans suffering from insomnia, with a total market of US $2 billion annually.
Osagie Imasogie, Chairman of Zelira, commented that "the positive outcome to this trial represents an important milestone for Zelira and its commitment to address the unmet need for clinically validated cannabis medicines and offer more treatment options to physicians and patients. Having successfully completed its recent merger, Zelira is now poised to rapidly commercialise the world's first clinically validated cannabis medicine for insomnia into global markets in 2020, including the US, based on the positive results of this study."
Mr. Osagie continued "these positive results add ZLT-101 to the Zelira portfolio of commercialized and to be commercialized, revenue-generating products derived from cannabinoids, such as HOPE™, in the US and globally, as a result of rigorous scientific work by the Zelira team. Zelira will continue to deploy its unique Launch, Learn and Develop a strategy to launch more scientifically validated products, targeting various conditions, into the market in 2020."
Following the trial, Zelira will produce a report covering the clinical study and an analysis of the endpoints will be provided by the end of March 2020.
Zelira will also seek to deploy its Launch, Learn and Develop strategy to commence supply of its clinically-validated insomnia formula in countries and states where medicinal cannabis has been legalized including Australia, the USA, Germany and the UK.
To learn more about Zelira Therapeutics, visit the company HQ here.
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