- AusCann Group (AC8) has completed its first clinical study for its THC and CBD combination hard-shell capsules
- AusCann was evaluating the use of its THC and CBD combination capsules compared to an oil formulation and the TGA-registered oral spray, Sativex
- Importantly, 57 per cent of patients experienced at least one adverse event with the oil, compared with only 28 per cent of those treated with the capsules
- In the TGA’s Sativex assessment report, the adverse event rate was 66 per cent, which is more than twice than the AusCann capsule
- AusCann will now progress to a phase 2a study of its hard-shell capsules for treating chronic neuropathic pain
- Company shares are up 6.25 per cent and are trading for 17 cents
AusCann Group (AC8) has completed its first clinical study for its proprietary Neuvis platform of self-emulsifying powder in hard-shell capsules.
The randomised, open-label, crossover phase one study was managed by Melbourne-based contract research organisation, Nucleus Network. It evaluated the pharmacokinetics and safety of a single dose in 28 healthy volunteers – 25 of whom completed the study.
The primary endpoints of the study were the pharmacokinetics of tetrahydrocannabinol (THC) and cannabidiol (CBD) and the main active metabolite of THC (11-hydroxy-THC), following oral doses of 2.5mg of THC and 2.5mg of CBD and 10mg of THC and 10mg of CBD.
“Our intent in conducting this study was to provide data to assist doctors in the use of our THC:CBD combination capsules and to make informed treatment decisions,” CEO Nick Woolf said.
Positively, AusCann’s hard-shell capsule showed it was similar to the comparator oil formulation and the Therapeutic Goods Administration (TGA)-registered oral spray, Sativex.
Importantly, however, the oil comparator resulted in more adverse events than with the AusCann capsule formulation. For example, 16 of 28 subjects, or 57 per cent, experienced at least one adverse event with the oil, compared with only seven of 25 subjects, or 28 per cent, treated with the capsules.
In the TGA’s assessment report of Sativex, the adverse event rate was 66 per cent, which is more than twice than the AusCann capsule.
“Having a pharmacokinetic curve that is optimised to an appropriate peak level with a more sustained duration, as was evident from this study with AusCann’s capsules, should translate to improved outcomes and reduced side effects for patients,” Chief Medical Advisor Dr Marc Russo said.
Now that the study is complete, AusCann will progress to phase 2a study of its hard-shell capsules for treating chronic neuropathic pain which is caused by damage to the brain, spinal cord or peripheral nervous system.
Company shares are up 6.25 per cent and are trading for 17 cents at 1:36 pm AEST.