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Zelira Therapeutics (ASX: ZLD) has announced its Phase 1b/2a medicinal cannabis trial to treat insomnia has met both its primary and secondary endpoints.

The company today confirmed it has received the final clinical report for the trial, which shows its proprietary cannabis formulation ZTL-101 has produced “statistically significant and dose responsive improvements” in Insomnia Severity Index (ISI) scores compared to the placebo.

The news follows Zelira’s announcement of positive results from the study in February.

Zelira chairman Osagie Imasogie said the trial’s positive outcome represents an import milestone for the company and its commitment to addressing the unmet need for clinically validated cannabis medicines to offer more treatment options to physicians and patients.

The company said it is now on track to launch the world’s first clinically validated medicinal cannabis product for insomnia this year, thereby expanding its portfolio alongside its HOPE product range.

“Zelira will continue to deploy its unique ‘launch, learn and develop strategy to launch more scientifically validated products, targeting various conditions, into the market in 2020,” Mr Imasogie said.

“Zelira’s clinically validated products, such as ZLT-101, continue to play a disruptive role in the traditional pharmaceutical industry,” he added.

Trial results

Undertaken at the University of Western Australia’s Centre for Sleep Science, the trial used a randomised, double-blind, cross-over design to assess the efficacy of ZTL-101 to treat patients with chronic insomnia symptoms.

A total of 23 patients were treated for 14 nights ZTL-101 and 14 nights with a placebo, separated by a one-week washout period.

Each participant took either a single (0.5ml of 11.5mg of total cannabinoids) or double (1ml of 23mg of total cannabinoids) dose of the medication, dissolved under the tongue, according to their symptoms.

According to Zelira, ISI scores decreased by an average of 26% across all participants, with those on the highest dose achieving a 36% reduction in scores.

Some of the measures making up the score included total sleep, awake times during the night, the time taken to fall asleep, quality of sleep and the feeling of being rested after sleep.

Zelira said the treatment was also shown to have “significantly improved” subjective measures of stress, fatigue and social functioning.

UWA Centre for Sleep Science director and principal investigator of the study, Professor Peter Eastwood said the study represented the “most rigorous clinical trial ever undertaken” to assess the therapeutic potential of medicinal cannabis to treat chronic insomnia symptoms.

“The significant improvement in subjective sleep quality and feelings of waking up rested as reported by participants was particularly notable. Positive patient experiences with minimal side effects are critical to the success of any insomnia drug and highlights the potential for ZTL-101 to address a key area of unmet need,” he said.

“Taken together, these results are comparable to other approved insomnia therapies at a similar stage of development and suggests that ZLT-101 can be developed as a novel treatment for chronic insomnia. This is a very exciting outcome,” Professor Eastwood added.

Next steps

Zelira said it will seek to deploy its ‘launch, learn and develop’ strategy to supply its formula in countries and states where medicinal cannabis has been legalised including Australia, the United States, Germany and the United Kingdom.

The company is anticipating its launch in the Australian market early in the third quarter of 2020.

It is also considering undertaking further clinical development of ZTL-101 in order to register the product in Australia.

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