U.S. , February 21, 2020 (420 INTEL) – It’s looking like Thunderbirds are go for a medical cannabis insomnia product developed by Zelira Therapeutics (ASX:ZLD).
In case you’re wondering who Zelira is, you might recognise it by its previous name – Zelda Therapeutics. The name change came about after a merger with the USA’s Ilera Therapeutics LLC was finalised late last year.
Zelda, err, Zelira has been working on an insomnia product, ZLT-101, for a few years. It first secured regulatory approval to conduct a clinical trial with chronic insomnia patients in Australia back in 2017.
On Wednesday the company announced it had met primary endpoints for its Phase (1b/2a) trial of ZLT-101. It states 23 chronic insomnia patients treated with ZLT-101 demonstrated statistically significant improvement in Insomnia Severity Index (ISI) scores compared to placebo. Additionally, ZLT-101 was well tolerated and no serious adverse events were reported.
This doesn’t mean to say it was free of side- effects. Among the patients who did experience them, the most common was dry mouth, followed by dizziness, headache and “feeling abnormal”. 17 of the 23 patients using ZLT-101 reported side effects, however, 4 participants on the placebo also reported them.
“All adverse events were classified as mild and had either resolved (97.5%) overnight or soon after waking each day or were resolving at the end of the trial,” states Zelira.
The company states lack of serious adverse or persistent mild adverse events is encouraging given those associated with other insomnia therapies.
“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,” stated Professor Peter Eastwood, who was the Principal Investigator for the study, and is also the Centre for Sleep Science’s Director. The Centre is based at the University of Western Australia.
While a final report from the clinical study won’t be available until the end of March this year, Zelira Chairman Osagie Imasogie said the company is now in a position to rapidly commercialise ZLT-101 globally – this year.
Chronic insomnia involves difficulty getting asleep, staying asleep or not feeling refreshed after adequate sleep, along with impairment of daytime function for a period of at least 4 weeks.