Bod Australia receives early green light to commence cannabis clinical trial

Cosmetics and natural medicines company Bod Australia (ASX: BDA) has surprised the market by announcing that it has secured ethics approval in a record time of six weeks from the Human Research Ethics Committee (HREC) in Australia.

The HREC has granted Bod Australia full ethics approval to begin cannabis phase I clinical trials, a step that can take as long as 12 months or more, depending on the nature of the proposal.

The trial which will determine the safety, tolerability and pharmacokinetics of its proprietary “ECs315” CBD extract, with the extracts being administered as a single or multiple sublingual wafer and oil to 24 healthy volunteers.

Bod Australia said the trial is now expected to begin in the “near-term and continue over a three-month period” in Melbourne, Australia, following the ethics approval from the HREC.

If the phase 1 trial is successful, Bod Australia could potentially obtain a standardised, reproducible and patent protected cannabis product which can be distributed or licenced to major pharmaceutical companies globally – a huge commercial coup that could be highly lucrative in the years to come to both Bod Australia and Australian consumers as the embryonic medical cannabis industry continues to develop in Australia.

Delving into medicinal cannabis

Bod Australia is primarily a developer and distributor of cosmetics and natural medicines, with a significant distribution footprint in the Australian market including access to over 900 pharmacies.

However, the multifaceted natural products developer is keen to build a “sustainable cannabis business” through astute supply and collaboration agreements and to develop a range of over the counter and therapeutic products based on GMP-certified cannabis extracts.

Gaining approval from the HREC is a significant milestone for Bod Australia as it ensures its cannabis phase 1 clinical trial design is ethically acceptable and in accordance with relevant standards and guidelines, including the National Statement and other international, Commonwealth, State and Territory regulations.

According to Bod Australia, the quick approval time is largely due to the superior quality of its proprietary ECs315 CBD extracts, the significance of its counterparties, a revised and improved clinical trial design and the calibre of personnel the company has assembled to progress the trial.

One of Bod Australia’s counterparties includes leading, Singapore-based company, iX Biopharma with a market capitalisation of around A$100 million, which will be manufacturing the sublingual wafer delivered during the trial.

Its other counter-party is Linnea SA, a prominent Swiss manufacturer of botanical extracts and pharmaceutical ingredients with which Bod Australia has a long-standing commercial relationship including a supply and collaboration agreement.

Linnea is currently a subsidiary of Ipsen and Schwarbe – a biotech giant with a market cap of around €11 billion.

“While the approval process can take upwards of 12 months in some cases, Bod Australia has managed to achieve it in approximately six weeks. This is a testament to the calibre of our proprietary cannabis extract, clinical trial design and leading team of personnel, which will assist us in our endeavours,” said Jo Patterson, chief executive officer of Bod Australia.

“Following success in the trial process, Bod Australia will have the exclusive rights to a unique finished product, with worldwide patent protection, which can be developed into a global brand. We will also have the ability to pursue additional research and test extract ECs315 on specific conditions such as post-chemotherapy nausea and vomiting,” she added.

Receiving rapid ethical approval is both a likely sign of Bod Australia’s strong application, but also, it is a possible sign of the times that the traditional prohibitionist approach to cannabis legislation is softening with Australian authorities very keen to fast-track commercial ventures aiming to take advantage of softening medicinal cannabis legislation in Australia and overseas in other cannabis-pacesetter nations such as Canada and the US.