Q&A with Osagie Imasogie, Chairman, Zelira Therapeutics: Zelira Phase 1b/2a Insomnia Clinical Trial Results

Q&A with Osagie Imasogie

 Chairman, Zelira Therapeutics

Zelira Therapeutics Ltd (Zelira; the Company) is a leading global therapeutic medicinal cannabis company with access to the world’s largest and fastest growing cannabis markets. The Company is focused on developing clinically validated branded cannabis products for the treatment of a variety of medical conditions. Product development programs are underway targeting specific conditions (e.g. Parkinson’s) and human clinical trial programs focused on insomnia, autism and opioid reduction with activities in Australia and the USA. The company has already launched two products, HOPE™, in the US market and plans to launch the product into the Australian market in 2H, 2020.

Zelira has released the final results of its recent insomnia clinical trial (ASX Announcement, 4 April 2020), undertaken in conjunction with the prestigious Centre for Sleep Science, at the University of Western Australia. The results achieved are a world-first clinical validation of the use of cannabis to treat chronic insomnia as reflected in Zelira’s proprietary medicinal cannabis insomnia formulation, “ZLT-001”.

You released the final results for your medicinal cannabis trial for insomnia so please tell us just what it revealed?

The results exceeded expectations. The trial of Zelira’s proprietary cannabis formulation (ZTL-101) met its primary and secondary endpoints and delivered statistically significant and dose responsive improvements in Insomnia Severity Index (ISI) scores. Treatment significantly improved objective and subjective measures of Total Sleep Time, Wake Time During the Night, Time to Sleep, Quality of Sleep and Feeling Rested after Sleep. Additionally, treatment also significantly improved subjective measures of stress, fatigue and social functioning.

What is the significance of these results?

The trial has yielded a comprehensive data-pack that supports our plans to launch the world’s first clinically validated insomnia product into global markets in 2020. In addition to insomnia, we think our drug could also be helpful for patients with indications such as chronic pain, mental and neurological disorders where insomnia is recognised as a key risk factor for these respective diseases.
This trial also gives doctors the data – and the clinical validation for prescribing/recommending ZTL-101 to their patients. There are very few cannabis derived drugs that can do that today.

How does Zelira’s medicinal cannabis formulation compare with other sleep drugs?

Other comparable sleep medicines have short term side effects (groggy, dizzy, tired, headaches, constipation and dry mouth) and long term side effects (dependence and tolerance, withdrawal symptoms, rebound insomnia, increased risk of depression, cancer, mood disorders etc.). Zelira’s ZLT-001 formulation has demonstrated to be both efficacious and safe, with no serious adverse side effects.
The results of this trial have demonstrated Zelira has a clearly differentiated insomnia product that is clinically validated and ready for market.

What is the scale of the market for insomnia treatment and is there much competition from similar products?

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.

What markets do you plan to sell into and when?

Zelira will supply its clinically validated insomnia formula in countries and states where medicinal cannabis has been legalised including Australia, the USA, Germany and the United Kingdom. The company remains on-track to launch in the Australian market in 2H, 2020.

What does this mean for the company?

These positive results add ZLT-101 to the portfolio of Zelira products being commercialised, including the recently launched HOPE™ range, in the US and globally, as a result of rigorous scientific work by the Zelira team. It consolidates our position as a global leader in the development of clinically validated cannabis medicines. It also further enhances the deployment of our unique Launch, Learn and Develop strategy to launch more scientifically validated products, targeting various conditions, into the market in 2020 and beyond.

Given your extensive experience in the pharmaceutical and healthcare sector, how do you see the future of medicinal cannabis therapies like ZLT-101?

Zelira’s clinically validated products, such as ZLT-101, will continue to play a disruptive role in the traditional pharmaceutical industry. In the traditional pharmaceutical industry, innovation, speed to market, good safety profiles and access are key factors that drive the development of successful new drugs. Zelira’s strategy of using cannabinoids as a nature product source of new drug candidates provides our company with high innovation, speed to market, good safety profiles for our drugs, particularly in comparison to the traditional pharmaceutical products already on the market and high accessibility for our patients.

The medicinal cannabis market is already taking away market share/revenue from traditional pharmaceutical markets. In 2019 it was estimated that traditional pharmaceutical products in the US alone, lost approximately $4.68 billion of their revenue to cannabis products. This figure will continue to grow and accelerate its rate of growth as we see more countries and states move to legalise medicinal cannabis. Zelira is well placed to meet this market demand and has demonstrated through its rigorous, scientifically based, clinical research, that we can provide the global market with safe and efficacious medicinal cannabis products that will be relevant to both physicians and our patients.