Bod Australia has received ethics approval for a phase IIB clinical trial investigating the efficacy of its new Schedule 3 CBD formulation in treating symptoms associated with insomnia.
Participant recruitment for the study — which will take place at sleep and respiratory research centre the Woolcock Institute of Medical Research — will start soon.
The double blind, randomised and placebo-controlled trial will investigate the effect of administering a 50mg and 100mg oral CBD product per day, versus a placebo, over an eight-week period with more than 200 participants.
Following completion, Bod said it expects to have sufficient data to commence product registration for a Schedule 3 low-dose CBD product with the Therapeutic Goods Administration and for it to be included on the Australian Register of Therapeutic Goods.
Bod told the ASX: “It is anticipated that completion of this process will provide Bod with a low-dose CBD product that can be sold over-the-counter by a pharmacist to Australian consumers without a prescription.
“This unlocks another channel to market for the company and has the potential to significantly increase domestic sales, underpinning additional revenue growth.”
CEO Jo Patterson added: “It’s very pleasing that ethics approval has been secured from the Bellberry Ethics Committee. This highlights our positive progress and brings us one step closer to commencing our planned clinical trial.
“Given the ongoing issues associated with pharmacological interventions designed to treat insomnia, we are very confident that there will be strong demand to participate in our trial.
“The completion of this trial will provide us with the basis to submit an application to the TGA, allowing Bod to become one of the first ASX-listed companies to register a Schedule 3 product for the Australian market.
“Additionally, we have engaged in numerous encouraging discussions with both our existing distribution networks and new potential partners to provide immediate sales upon registration.”
