Bod Science Limited provided the following update on their phase IIB clinical trial for a new Schedule 3 CBD product for the Australian market being undertaken by Australia's leading sleep research organisation, the Woolcock Institute. The trial assesses the efficacy of a uniquely developed Schedule 3 (Pharmacist Only) CBD formulation on symptoms associated with insomnia in 198 participants over 8 weeks. Schedule 3 products can be sold to Australian consumers over the counter without a prescription.

Bod's trial is a double blind, randomised and placebo-controlled investigation of the effect of administering 50mg and 100mg oral doses of a proprietary CBD product per day versus a placebo,. The Phase IIb clinical trial is the final step in R&D for the new product and is expected to provide sufficient data for application to register a low dose CBD product with the TGA. Bod's unique CBD formulation is presented in a soft gel format and utilises a patent protected encapsulation technology that improves the bioavailability of the CBD extract.

The clinical trial is one of the first registered in Australia for a Schedule 3 product. Completing a major milestone in the study, the trial screening has endedwith randomisation expected to be completed by the end of the month (signifying Bod are moving into the final recruitment of last patients). 370 patients have been screened in total, with the Company on track to meet their recruitment target of 198 by end of March 2023.

In order to ensure a consistent patient base for the study and minimise variation, potential patients have undergone rigorous screening. Trial results have been collected on both a qualitative and quantitative data and utilised a new technology involving smart watches to enable more efficient data collection. On completion of the data capture from this last patient, the trial focus will immediately move to the analysis of the data.

Bod is confident that it will have sufficient data to progress to a registration under Schedule 3 for a low dose CBD product with the Therapeutic Goods Administration (TGA). 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.