Cannabis-focused drug development and product innovation company Bod Science (ASX:BOD) has updated investors with preliminary topline results from their phase 2B clinical trial for a new Schedule 3 CBD product.
The company said complete results are expected within five weeks.
The trial assessed the efficacy of a Schedule 3 CBD formulation on symptoms associated with insomnia in 208 participants over eight weeks. The study design randomised patients to receive daily doses of double-blind study medication of either CBD 50mg, CBD 100mg, or placebo for the eight-week period.
The statistically powered primary endpoint compares Insomnia Severity Inventory (ISI) scores for each dose compared to placebo.
The ISI is a patient questionnaire completed at baseline (before study medication), then at weeks four and eight. The study included an objective measure of sleep using actigraphy data gathered from a smartwatch worn by patients for seven days before taking study medication and then again for the final seven days of study medication at week eight.
The company said the primary endpoint analysis showed no statistically significant difference between either CBD dose compared to placebo when tested at the 0.025 statistical significance level.
Analysis of the primary endpoint on the per-protocol population showed a statistically significant benefit of CBD 100mg compared to placebo when tested at the 0.05 statistical significance level.
The company said it plans to continue commercialisation discussions and meetings with the TGA to discuss pathways towards Schedule 3 registration.
CEO Jo Patterson said, “The trial completion marks a significant breakthrough for Bod for our uniquely formulated Schedule 3 CBD product. The singularity of this product is in its’ soft gel format - utilising a patent protected encapsulation technology, presents enormous opportunity both through existing permitted pathways, and through other global markets.
“As we know, sleep is so central to our health and wellbeing, and the birth of this new product is certainly an exciting journey not only for our business but the cannabis market more broadly."