Medlab Clinical’s Phase III clinical trial of its lead non-opioid pain relief candidate, NanaBis, will use a synthetic cannabinoid formulation.
Based on feedback from a number of regulators, including the US Food and Drug Administration (FDA), Medlab said a synthetic, pharmaceutical-grade formulation was preferable to a botanical one as it allowed for greater product control, from downscale development activities through to manufacturing.
CEO Dr Sean Hall said: “A synthetic formulation will allow us to more closely control product development variables that could otherwise impact the manufacture and delivery of a pharmaceutical product at scale [compared to] a botanical formulation.”
In a statement to the ASX, the company said the move will enable it to produce NanaBis at an industrial scale to the highest quality and consistency.
“This is a challenge if we need to rely on botanical extracts which, by their very nature and reproductive patterns, have multiple variations and well-documented purity issues,” it added.
Medlab said the “aggressive path to market” would enable it to produce high-quality cannabinoids for major unmet needs and open up multibillion-dollar global markets including bone cancer pain and non-opioid pain alternatives.
It added research and evaluations have demonstrated that NanaBis is a fast-acting, viable alternative to opioids, improving pain management and quality of life.
Medlab’s Phase III clinical trial in 360 patients with cancer bone pain will seek to demonstrate patients treated with NanaBis have a higher response rate after six weeks compared to patients in the placebo group.
Medlab said it will continue to develop therapies based on natural plant extracts for other indications.