Bod Science CEO Jo Patterson has said the firm is “feeling confident” it will successfully register a low-dose CBD insomnia product for over-the-counter (schedule 3) sales in Australia.
Her optimistic outlook came as the company announced it had completed trial screening for its phase IIb clinical trial examining the efficacy of its soft-gel CBD formulation on insomnia symptoms.
A total of 370 patients have been screened, with the company on track to meet its recruitment target of 198 by the end of March. Bod said potential participants underwent rigorous screening to ensure a consistent patient base and minimal variation.
The eight-week, double blind, randomised trial will be conducted by sleep research organisation the Woolcock Institute and test the efficacy of 50mg and 100mg daily doses of Bod’s proprietary product versus a placebo.
Bod told the ASX it was confident it would have “sufficient data to progress to a registration under schedule 3 for a low-dose CBD product with the Therapeutic Goods Administration (TGA)”.
It added: “In preparation for this, Bod is compiling the registration dossier in parallel with the trial progression, and therefore is well advanced for submission to the TGA.
“With a potential market valued at A$250 million, the new product will unlock another channel for Bod to significantly increase domestic sales, and importantly, the clinical trial has the potential to unlock opportunities in the growing global insomnia market, which is expected to reach US$6.38 billion in value by 2030.”
CEO Jo Patterson said: “The trial screening ending marks a major milestone for Bod in the clinical trial for our uniquely formulated schedule 3 CBD product.
“We are feeling confident as we move toward the next phase of the study – the analysis of trial data. We anticipate it will provide us with the necessary information to progress our product registration and commercialise a new, low-dose CBD product for the Australian market.”
So far, cannabis firms have struggled to prove the efficacy of low-dose CBD as an insomnia treatment.
In January, Cann Group revealed its phase III study had not produced the desired result, with patients administered its schedule 3 candidate Satipharm showing no significant difference in their sleep to those not taking CBD.
And later the same month, Ecofibre saw its hopes thrown into doubt after a phase III clinical trial conducted by Southern Cross University’s National Centre for Naturopathic Medicine failed to show sufficient differences between its schedule 3 candidate and a placebo.
Both companies have vowed to press on with their plans.
