Cymra Life Sciences has announced encouraging results from a phase II clinical trial examining whether its Cybis THC:CBD oil can help patients managing chronic neck and back pain.
The non-randomised, single-arm, open-label study enrolled 28 adult participants who received escalating doses of Cybis 10:25 across two Sydney sites between October 2021 and June 2022.
Across all doses, participants showed meaningful pain reductions compared to their starting levels, and also reported lower rates of depression, anxiety and stress, along with improvements in mood, enjoyment of life and walking ability.
At 1.0 mL bd doses, the study recorded a mean pain reduction of 28.8% (median 28.6%), rising to a mean of 34.1% (median 37.5%) at 1.5 mL bd doses.
Although participants self-reported numerical increases in sleep disturbance, sleep adequacy showed improvement as doses increased.
Cybis 10:25 was generally well tolerated throughout the trial, with 82% of participants experiencing at least one adverse event, most of which were mild or moderate in severity.
Professor Richard Chye, a pain specialist at St Vincent's Hospital and medical advisor to the study, said: "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."
Cymra is now seeking investment to finance a larger phase III study, with the goal of submitting for registration with the Therapeutic Goods Administration (TGA) and securing a listing on the Pharmaceutical Benefits Scheme.
Chronic pain affects three million Australians, many of whom have few effective treatment options available to them.
CEO Joel Hardy said: "Pharmaceutical opioids are now responsible for far more deaths, poisonings and hospitalisations in Australia than illegal opioids such as heroin. These positive study results show that Cybis as a second-line therapy prior to opiates is safe and effective and gives us the confidence to proceed to a phase III study… and subsequent submission for approval by global regulatory agencies such as the TGA.
"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."
The company launched a new range of flower products last year under the Superbly Green brand, offering six strains aimed at conditions including insomnia, anxiety and pain.
Co-founder and chief operating officer Simon Pettinger added: "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."
