Australia’s Zelira Therapeutics (ASX:ZLD) is claiming a win in demonstrating its medicinal cannabis preparation helps people suffering insomnia.
Its product, with the less-than-glitzy name of ZLT-101, is ingested sublingually*. The company says a Phase 1b/2a clinical trial of ZLT-101 against insomnia has seen ZLT-101 pass with “flying colours”.
Undertaken at the University of Western Australia (UWA) Centre for Sleep Science (CSS), the trial involved 23 volunteer patients with chronic insomnia being treated over September 2018-December 2020 states Zelira (that 2020 may have been a typo in the company’s release).
“We have given physicians the clinical evidence to prescribe this compound,” said Dr Richard Hopkins, Managing Director, ex-US markets, at Zelira Therapeutics. “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.”
Zelira will says it will supply ZLT-101 in markets including the UK, US, Australia, Germany and the UK. There will certainly be plenty of potential customers – for example, Zelira states insomnia affects around 30% of the US population. However, insomnia’s impacts vary and medications such as ZLT-101 are targeting those with a chronic condition; i.e. those with symptoms including difficulty falling asleep, and/or in staying asleep occurring over a long period.
The randomised, double-blind, cross-over trial saw treated patients indicating 26% improvement in their Insomnia Severity Index (ISI) scores. Patients on the highest dose reported 36% improvement in symptoms. Zelira says only minor adverse events were reported, including dry mouth and headache, with 96% of symptoms self-resolving by the following morning.
Professor Peter Eastwood, who is the Director at the Centre for Sleep Science at UWA, said the ZLT-101 study represents the most rigorous clinical trial assessing the therapeutic potential of medicinal cannabis to treat chronic insomnia ever undertaken.
Tuesday’s announcement follows on from an early report in February indicating positive results from the ZLT-101 trial.
Zelira Therapeutics was previously known as Zelda Therapeutics. The name change occurred after a merger with the USA’s Ilera Therapeutics LLC, which was finalised late last year.
* The ingestion of a medicine sublingually means it is placed under the tongue, where it is absorbed into the bloodstream through the mucous membranes.