Zelira Therapeutics Completes World's First Clinical Trials for Treatment of Insomnia with Medical Cannabis

Industry's first clinically validated cannabinoid-based insomnia medication will launch globally

PHILADELPHIA, April 7, 2020 /PRNewswire/ -- Zelira Therapeutics Ltd (ASX: ZLD, OTCQB: ZLDAF), a global leader in the development of clinically validated cannabis medicines based in both Perth, Australia and Philadelphia, is pleased to announce it has received the final report for its ZTL-101 medicinal cannabis trial for insomnia. Its findings represent a world-first clinical validation demonstrating that ZTL-101 cannabis treatment is safe and effective for chronic insomnia. These results open prospects to launch and distribute this product in global markets including the USA in the second half of 2020.

The trial was undertaken at the world-class University of Western Australia (UWA) Centre for Sleep Science and was led by principal investigator Professor Peter Eastwood, and used a randomized, double-blind, cross-over design to evaluate the efficacy of Zelira's proprietary cannabis formulation (ZTL-101) to treat patients diagnosed with chronic insomnia. Twenty- three patients were treated for 14 nights with ZTL-101 and 14 nights with placebo, separated by a one- week washout period. After dosing commenced, each participant was able to take a single (0.5ml of 11.5mg total cannabinoids) or double (1 ml of 23mg total cannabinoids) their dose of the medication, delivered sublingually, according to their symptoms.

Dr. Oludare Odumosu, Managing Director Zelira USA said, "We are pleased with the results of the study. This trial has yielded a comprehensive data-pack that supports our plans to launch the world's first clinically validated cannabinoid-based insomnia medicine into global markets this year."

Odumosu continues, "We acknowledge the dedicated team at the UWA Centre for Sleep Science and we thank the patients and supporting investigators who participated in the study."

An estimated 70 million Americans have insomnia where the market for prescription and over-the- counter medications is forecast to be worth over US$4 billion in annual revenue by 2022. Zelira is leading the development of clinically validated full spectrum cannabis medicines to access global markets for insomnia medications.

Professor Peter Eastwood, Principal Investigator for the study, and Director at the Centre for Sleep Science at the University of Western Australia said, "This study represents the most rigorous clinical trial ever undertaken to assess the therapeutic potential of medicinal cannabis to treat the symptoms of chronic insomnia. The fact that ZLT-101 treatment achieved statistically significant, dose responsive improvements across a broad range of key insomnia indices is impressive, particularly given the relatively short two-week dosing window."

Analysis showed treated patients slept significantly longer, went to sleep faster and went back to sleep sooner after waking. Patients also reported significant improvement in quality of life measures including feeling rested after sleep, feeling less stressed, less fatigued and improved overall functioning.

Insomnia is a large unmet medical need. It affects ~30% of the US population and is a major risk factor for patients suffering chronic pain, neurological disorders (Parkinson's, dementia), mental disorders (anxiety, depression, anorexia) and cardiovascular disease.

The market for prescription and over-the-counter medications to treat the condition in the US generates more than US$2 billion (A$3.3 billion) in annual revenue. As well as the US, Zelira will also aim to supply its insomnia formula in other markets where medicinal cannabis has been legalized including the US, Australia, Germany and the UK.

These positive results add ZLT-101 to the portfolio of Zelira products being commercialized including the recently launched HOPE™ range, in global markets including the US, Australia, Germany and the UK. The company is also undertaking further human clinical trials for autism and opioid reduction and is on-track to bring additional products for aged care and oral-healthcare to market later in 2020.

Osagie Imasogie, Chairman of Zelira, commented, "The positive outcome to this trial represents an important milestone for Zelira and its commitment to address the unmet need for clinically validated cannabis medicines and offer more treatment options to physicians and patients. Zelira's clinically validated products, such as ZLT-101, continue to play a disruptive role in the traditional pharmaceutical industry."    

Full AXA version: https://www.asx.com.au/asxpdf/20200407/pdf/44gs3s7427zrmt.pdf

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About Zelira Therapeutics (www.zeliratx.com)
Zelira Therapeutics Ltd is a leading global therapeutic medicinal cannabis company with access to the world's largest and fastest growing cannabis markets. Zelira owns a portfolio of proprietary revenue generating products and a pipeline of candidates undergoing clinical development that are positioned to enter global markets from 2020. The company is focused on developing branded cannabis products for the treatment of a variety of medical conditions.

The Company is undertaking product development programs targeting specific conditions (e.g. HOPE™) and human clinical trial programs focused on insomnia, autism and opioid reduction with activities in Australia and the USA.

The Company conducts this work in partnership with world-leading researchers and organizations including Complutense University in Madrid, Spain; Curtin University in Perth, Western Australia; the Telethon Kids Institute in Perth; the University of Western Australia, in Perth; St. Vincent's Hospital in Melbourne, Australia; and the Children's Hospital of Philadelphia (CHOP) in the United States.

The Company has developed two proprietary formulations (HOPE™) already launched and generating revenues in Pennsylvania, has laboratory capabilities to develop formulations in Pennsylvania and Louisiana with ability to conduct clinical trials and is establishing a national footprint across the US for the licensing of its products.

Cision

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SOURCE Zelira Therapeutics Limited