Zelira Therapeutics says ZLT-101 on track to launch later this year

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Perth-based medicinal cannabis company Zelira Therapeutics (ASX:ZLD) has announced it has demonstrated its formulation ZLT-101 works for people suffering insomnia. 

The company said ZLT-101, ingested sublingually, has successfully navigated a Phase 1b/2a clinical trial against insomnia.

“We are delighted as these results have exceeded our expectations,” said managing director Dr Richard Hopkins. “Globally we are the first company to take a full-spectrum cannabis product and test it for efficacy in the insomnia space.”

“We have given physicians the clinical evidence to prescribe this compound,” continued Dr Hopkins. “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.”

The trial used a randomised, double-blind, cross-over design where patients were treated for 14 nights with ZTL- 101 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.

The company said ZTL-101 was shown to be safe, as measured by participants reporting only minor adverse events. These included dry mouth and headache with 96 per cent 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," said the company.

"Treated patients showed 26% improvement in their Insomnia Severity Index (ISI) scores – a current standard for measuring 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."

The company said patients also reported significant improvement in quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.

It said the positive result means ZLT-101 is on‐track to launch in the second half of 2020.