Australian biotech leading the way in medicinal cannabis for chronic pain
Cymra Life Sciences, a privately owned Australian medicinal cannabis biotech, has its sights firmly set on the $63 billion global chronic pain market with exciting new clinical data on the use of its lead product prior to opiates.
In a global first, they have completed a phase II clinical trial using their Cybis® THC:CBD oil resulting in statistically and clinically significant results, including a 38% median reduction in pain for patients living with chronic neck and back pain.
“This research offers hope to the millions of Australians living with chronic neck and back pain. It is an important leap forward in strengthening the clinical evidence and safety for the treatment of chronic pain with medicinal cannabis,” says Clinical Professor Richard Chye, pain specialist at St Vincent’s Hospital and medical advisor to the study. “Cybis® produced statistically and clinically significant pain reduction in moderate to severe chronic neck or back pain. It was well tolerated with the majority of adverse events being of a mild nature. It also reduced depression, anxiety and stress, with improvements in general activity, mood, walking ability, work, relationships and enjoyment of life.”
In a field dominated by studies involving adding trial medication to existing standard of care, this study is unique for its focus solely on assessing medicinal cannabis and its effects in isolation, setting it apart from the majority of research in this domain.
Chronic pain is arguably the fastest growing medical condition in the world for which treatment options are very limited. Three million Australians suffer from chronic pain and it costs the economy over $73 billion per annum – with costs predicted to continue to rise. There is a huge unmet need in treatment options, particularly given opioids are restricted by regulatory bodies and have long term side effects.
The number of active medicinal cannabis patients in Australia has increased from almost zero in 2018 to 122,000 in 2021[iii], with numbers estimated to increase to 670,000 by 2030[iv],” The Therapeutic Goods Administrator (TGA) has given more than 250,000 approvals since 2016 under the SAS-B pathway. Around 60% of the approvals are for chronic pain.
The market value in Australia for medicinal cannabis in predicted to be $290 million in 2023[v], increasing to $1.35 billion by 2032[vi].
Nicolette Ellis, President of Chronic Pain Australia says "Medicinal cannabis is a highly sought treatment for chronic pain and some people with chronic pain have exceptional benefits. Treatment can be difficult to access and very unaffordable. Of the hundreds of thousands of applications to Australia’s medicines regulator for special access to medical cannabis, chronic pain is the top reason given, which shows the desperation from the chronic pain community to find treatment for relief.”
Cymra’s 4.2ha site in the Northern Rivers NSW can produce $50 million in product revenue at full capacity, with revenue projections of $15 million in FY24. The company is now seeking investment to assist with funding a larger Phase III study in order to submit for registration with the Therapeutic Goods Administration (TGA) and list on the Pharmaceutical Benefits Scheme.
“Pharmaceutical opioids are now responsible for far more deaths, poisoning and hospitalisations in Australia than illegal opioids such as heroin. These positive study results shows that Cybis® as second line therapy prior to opiates is safe and effective and gives us the confidence to proceed to a Phase III study with Cybis® and subsequent submission for approval by global regulatory agencies such as the TGA,” says Joel Hardy, CEO of Cymra. “Our strategy is to focus on two key areas. Firstly, clinical product development to register Cybis as a second line therapy for chronic pain. Secondly, genetics and flower production to meet the exploding global demand for high grade pharmaceutical cannabis products.”
Cymra Life Sciences is the only business to patient Australian cultivator of organic medical cannabis products that grow sustainably their own product in living soil, using the rich red volcanic soil from the Bryon hinterland. They also recently released a new range of flower products in 2022 under the Superbly Green brand, with six different strains targeting indications such as insomnia, anxiety and pain.
“Due to unprecedented demand, we are currently doubling our greenhouse capacity so that we can increase production capacity by over 200% over the next two years. As we own and control parts of the value chain, we will provide differentiated Australian grown organic products, own the intellectual property, reduce costs, produce higher product margins, and have reliable supply for domestic and overseas markets,” says Simon Pettinger, Co-Founder and Chief Operating Officer at Cymra.
“A sustainable approach to cannabis cultivation starts with good soil management, which is why we built our organic production beds on top of our farm’s rich red volcanic soil. We are not using pesticides, chemicals or fertilisers, and provide complete transparency around how we grow our products, rather than just importing cannabis in a jar and placing a label on it with no real idea on its origins and how its grown. It takes a lot of effort, but the results are worth it – our patients tell us it tastes and smells better, plus it’s a lot better for the environment,” finished Mr Pettinger.
For more information on Cybis® THC:CBD oil visit https://cymra.com.au/cybis-
[ii] https://www.
[iii] https://www.tga.gov.au/