LEVIN Health (“Levin”, or “the Company”), a leading Australian sports science company committed to solving some of the most challenging health issues facing the wider community, has received ethics approval for its Phase 2a clinical trial to evaluate the efficacy of its licensed cannabinoid formulation in treating patients with chronic pain, receiving ethics approval.
Undertaken in collaboration with La Trobe University’s Sport and Exercise Medicine Research Centre (Melbourne, Australia), the world-first, randomised, double blind, placebo controlled clinical trial will investigate the use of LEVIN Health’s licensed formula as an effective use of medicinal cannabis in treating people with chronic pain specifically following musculoskeletal injury with world-renown sports medicine expert Professor Peter Brukner as Principal Investigator.
With the approval now formally received from the Bellberry Human Research Ethics Committee (HREC), LEVIN Health expects the trial to commence in April 2022, with an expected target of 114 patients enrolled.
LEVIN Health has licensed the formula from ASX-listed Zelira Therapeutics (ASX:ZLD) under a Licensing and Project Management Agreement signed in June 2021. Under the terms of the agreement, LEVIN Health will provide the funding for the trial and Zelira will be contracted to project manage the trial.
Professor Peter Brukner said “Chronic musculoskeletal pain impacts millions of Australians every year, creating a huge burden on the individual and society. People with chronic musculoskeletal pain also can experience other symptoms such as anxiety and/or depression and gastrointestinal issues.
“La Trobe University is very excited to be investigating the effectiveness of medicinal cannabis in treating people with chronic pain following musculoskeletal injury, in a world-first randomised, double blind, placebo controlled clinical trial.”
Interventional Pain Physician, and Chair of the Sports Medicine Australia Research Foundation, Associate Professor Bruce Mitchell and member of LEVIN Health’s Medical Advisory Board has acknowledged the medical profession’s insistence on robust research.
“I congratulate LEVIN Health and wish them well with the trial. It will provide exactly the robust evidence from a gold-standard study that the Faculty of Pain Medicine of the Australian and New Zealand College of Anaesthetics has called for,” he said.
The global chronic pain landscape represents a $77.8Bn (USD) industry and in Australia alone, there are over three million chronic pain patients with a cost of $12.2B AUD to the economy. The success of the trial will allow LEVIN Health to register a medicine with the TGA and commercialise globally outside of North and South America.
It will also create further opportunity for the Company’s growth strategy for its growing suite of products.
LEVIN Health Managing Director Mark Brayshaw is delighted the Company is now one step closer to building out its diversified portfolio.
“Our vision is to help solve the challenges faced by current and former athletes and help everyday people stay active and live a healthy lifestyle. As such, we work with world-leading researchers to explore and conduct evidence-based sport science related research.
“Receiving HREC approval for our trail is a huge step forward for LEVIN Health. It will be the first and only gold-standard clinical trial in the world, evaluating the efficacy of medicinal cannabis in the treatment of chronic, non-cancer pain. Our investment in this phase 2 clinical trial will separate LEVIN Health from our competitors.
“This is just one trial in our long-term strategy and will be a very valuable asset once completed.”