Cannabis clinical trial underway with Emerald Clinics
Poised to commercialise insomnia drug
Fundraising accelerates clinical trials and path to market
Cannabis clinical trials
Zelira Therapeutics Ltd (ASX:ZLD) is working with world-leading researchers and organisations to develop branded cannabis products for the treatment of a variety of medical conditions and is undertaking human clinical trial programs in Australia and the USA.
The company has enrolled its Phase 1 Dose Escalation Trial for the use of medical cannabis for patients on long-term opioid treatment, which is being conducted with partner Emerald Clinics Ltd (ASX:EMD) to evaluate the safety and tolerability of dosing patients that have chronic non-cancer pain on long-term opioid pain relief.
Dosing is expected to be completed by April 2020 with the final report to be provided by mid-2020.
Autism and Parkinsons disease
Zelira has undertaken pilot clinical studies in Chile to assess the efficacy of medicinal cannabis formulations in children diagnosed with autism.
Real-world data collected from these clinical studies and from patients using Zelira’s HOPE® product is being used to guide the design of an interventional trial aimed at assessing the efficacy of different cannabis formulations to treat autism.
The company has also partnered with the Parkinson’s Foundation in the US to gather insights from people living with Parkinson’s Disease about their understanding of and use of medical cannabis and hemp-derived therapies.
This involves the development of a survey tool to be sent to people with the diseases to understand why and how they are using medical cannabis and hemp-derived CBD products.
The results will guide Zelira towards a possible future clinical trial on the safety and efficacy of medical cannabis use by people with Parkinson’s disease.
Insomnia drug potential
After positive results from its clinical insomnia trial, Zelira is poised to commercialise the world’s first clinically validated cannabis medicine for insomnia into global markets in 2020.
The trial confirmed that ZLT-101 therapy achieved the primary endpoint of a statistically significant improvement in insomnia severity index scores in 24 patients diagnosed with chronic insomnia aged between 25-70.
The study was a randomised, double-blind, cross-over design involving 14 nights of ZTL-101 and 14 nights of placebo, separated by a one-week washout period.
A final report including an analysis of a comprehensive suite of secondary endpoints will be provided by end of March 2020.
Zelira will also then aim to commence supply of its clinically validated insomnia formula in countries and states where medicinal cannabis has been legalised including Australia, the USA, Germany and the UK.
Zelira's product pipeline
Placements secure funding
Zelira recently accepted applications from overseas investors for an additional 1.08 million shares as part of a share placement.
Following the acceptance of oversubscriptions, the placement’s total size increased to $4.64 million.
This comes after the company successfully completed an initial placement of shares at 5 cents per share to Australian and international investors in February which to raised $4,588,500.
The funds raised from the placements will be used to accelerate Zelira’s plans to launch multiple products into global markets in 2020 and to advance its clinical programs.
Global commercialisation plans
In November 2019, Zelira announced it had entered a distribution agreement with Health-House International Ltd to distribute Zelira-branded products, including HOPE®, in Australasia and the United Kingdom.
In December 2019, Zelira completed a licensing transaction with an agreement with Advanced Biomedics to license HOPE® into Louisiana, US.
The company expects to announce multiple licensing deals in 2020 as it continues to roll-out HOPE® in other US-states and into global markets in 2020.
Zelira also has an established strategic partnership with German-based HAPA pharm BV to supply pharmaceutical-grade medicinal cannabis formulations for its clinical trials.
The agreement through the German distribution network also offers a credible and rapid path to commercialisation which Zelira hopes to achieve this year.