Pharmaceuticals company AusCann (ASX: AC8) is set to progress to the next stage of clinical trials having successfully completed their first round on Neuvis, their cannabinoid-based capsule developed to treat nerve pain – an area of medicine that is inadequately met.
Estimated to affect 7-10% of Australians, nerve pain is caused by damage to the brain, spinal cord or peripheral nervous system where current treatments do not remain in the bloodstream long enough, requiring repeat doses and expenses – something AusCann is addressing with their hard shell capsule.
From their recently-completed Phase 1 clinical trials, 25 healthy volunteers trialed Neuvis to evaluate the pharmacokinetics and safety of a single dose. Orally administered, the capsule contains tetrahydrocannabinol (THC) and cannabidiol (CBD) which are combined by AusCann’s proprietary Neuvis platform of self-emulsifying powder.
Following the trials, fewer treatment-related adverse events were observed with AusCann’s product versus the comparator oil and Sativex.
“I am delighted by the results from this Phase I study of our hard-shell capsules using AusCann’s novel Neuvis platform,” said AusCann CEO, Nick Woolf.
“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.
“Our capsules are presented in a familiar dose form so that Healthcare Professionals can have confidence in dose uniformity and ease of use for their patients, which should enhance patient compliance and correct dosing.”
The trial’s comparative product Sativex is already approved by the Therapeutic Goods Administration (TGA) however being an oral spray, the delivery method bypasses the gastro-intestinal tract and liver metabolism.
Through the different delivery method, the Neuvis capsule ratio of CBD to THC drug exposure (0.8) was closer to a 1:1 ratio than the ratio achieved for the comparator (0.7) or reported for the Sativex oral spray (0.6). It was also identified that 28% of treated volunteers experienced an adverse effect compared to 57% that were exposed to the comparator.
“Some formulations peak too fast, causing side effects, and then do not remain in the blood stream for long enough, which increases the number of doses a patient requires per day,” said AusCann Chief Medical Officer, Dr Marc Russo.
“This increases the cost for patients and decreases compliance. 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.”
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