Bod Science CEO Jo Patterson says the company is "feeling confident" it will secure over-the-counter (schedule 3) registration for a low-dose CBD insomnia product in Australia.
Her upbeat assessment accompanied an announcement that the company had finished screening participants for its phase IIb clinical trial, which is evaluating the effectiveness of its soft-gel CBD formulation in treating insomnia symptoms.
In total, 370 patients were screened, with the company on course to hit its recruitment target of 198 by the end of March. Bod noted that potential participants went through thorough screening to maintain a consistent patient base and limit variability.
The eight-week, double-blind, randomised trial is being run by sleep research organisation the Woolcock Institute and will assess daily doses of 50mg and 100mg of Bod's proprietary product against a placebo.
Bod informed the ASX that 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)".
The company 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."
Cannabis companies have so far found it difficult to demonstrate the efficacy of low-dose CBD as a treatment for insomnia.
In January, Cann Group disclosed that its phase III study had not produced the desired result, with patients taking its schedule 3 candidate Satipharm showing no meaningful improvement in sleep compared to those receiving no CBD.
Later that same month, Ecofibre's prospects were thrown into uncertainty 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 committed to continuing with their respective plans.
