Zelira Therapeutics Ltd (ASX:ZLD) (OTCMKTS:ZLDAF) (FRA:G1G) is encouraged that the results of a trial in chronic insomnia patients of its proprietary cannabinoid ZLT101 formulation marketed as Zenivol® have been published in the peer-reviewed journal SLEEP®.
The double-blind, placebo-controlled, cross-over trial was carried out by the University of Western Australia’s investigational team.
First announced in February 2020, the results of this trial were the world’s first clinically validated cannabis formulation for treating insomnia.
Zelira continues to lead the world in creating and validating proprietary medicinal cannabis products such as Zenivol with a focus on taking these drugs through regulatory registration.
Higher level of confidence
The company’s managing director Oludare Odumosu said: “Physicians and patients often ask for published peer-reviewed data from a double-blind, placebo-controlled, cross-over study.
“With this publication in the prestigious and high impact journal of SLEEP of the results from the University of Western Australia’s trial, we can confidently say ‘here you have the first scientific peer-reviewed publication for a cannabinoid medicine to treat insomnia’.
“Now, prescribers will have a higher level of confidence in using Zelira’s Zenivol to treat their patients battling chronic insomnia.
“Zelira is committed to taking Zenivol through registration approval as the worlds’ first fully validated and approved cannabinoid treatment for chronic insomnia.”
SLEEP journal
SLEEP, the official publication of the Sleep Research Society, is the benchmark international journal for all sleep-related conditions with a mission to publish innovative, high-impact research findings across the basic, translational, and clinical research spectrum.
Publication in the prestigious SLEEP journal provides the foremost evidence-based, peer-reviewed clinical trial data for doctors who treat patients with chronic insomnia.
The trial
The trial was undertaken at the world-class University of Western Australia Centre for Sleep Science and was led by principal investigator Professor Peter Eastwood with Jennifer Walsh as the corresponding author.
Zelira first announced the positive Phase 1b/2a results on February 19, 2020, and provided additional detail on the primary and secondary endpoints achieved on April 7, 2020.
The proprietary Zenivol formulation was launched in Australia in September 2020 and is available to prescribers and patients through the Therapeutic Goods Administrations (TGA) Special Access and Authorised Prescriber Schemes.
Lead author Jennifer Walsh said: “The results demonstrate significant improvements in a number of important insomnia metrics which is encouraging preliminary evidence that ZTL-101, Zelira’s Zenivol, has potential to treat this highly prevalent condition.”