Bod Australia kicks off phase 1 clinical trial for phytocomplex cannabis extract
A Phase I clinical trial of Bod’s unique ‘cannabis wafer product’ has been approved by the Australian Government’s Therapeutic Goods Administration.
Cosmetics and natural medicines company Bod Australia (ASX: BDA) has stormed into a phase 1 clinical trial to test the safety, tolerability and pharmacokinetics of Bod’s proprietary phytocomplex cannabis extract (ECs315).
The news means that Bod will commence first patient visits as of today and will involve trial subjects receiving initial doses of its proprietary cannabis extract. Following this phase, a second trial segment will begin in August with the clinical trial expected to be completed in its entirety by November 2018.
Bod Australia CEO Jo Patterson told Small Caps that Bod is already look at next steps including a potential phase 1b trials that involve sick patients or phase 2 trials that add specificity to what Bod’s products could potentially treat when finally developed.
The medical cannabis market has undergone strong growth and development over the past few years, underpinned by regulatory allowance and softening of existing laws that have traditionally banned cannabis as a medical option for clinicians.
Countries such as Germany, the UK, the US, Canada and Australia are leading the way forward in terms of opening up a new medical niche market based on cannabis, which Bod Australia is looking to capitalise on by developing commercially-viable treatments using cannabis extracts.
Positive early signs of medical cannabis include the approval of America’s first cannabis-based drug by the US Food and Drug Administration (FDA), earlier this year.
Epidiolex is the first FDA-approved drug that contains a purified drug substance derived from cannabis. Importantly, it is also the first time the FDA has approved a drug specifically for the treatment of patients with Dravet syndrome.
The approval is a sign of “green shoots and a likely indicator of future drug development,” according to Ms Patterson.
Bod Australia is primarily a developer and distributor of cosmetics and natural medicines, with a significant distribution footprint in the Australian market.
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.
In the past few months, Bod has recently completed a number of pivotal steps towards the commencement of its phase 1 trial, including trial site initiation, product formulation of the trial-ready product, patient recruitment and screening processes and gaining regulatory approvals from the Therapeutic Goods Administration (TGA).
Commercial distribution
From a commercial perspective, Bod has also been active in recent weeks. The company has also looked to expand its distribution network in order to boost sales nationwide.
Bod secured an agreement with one of Australia’s leading pharmaceutical wholesalers, Symbion last month. Under the agreement, Symbion will stock Bod’s range of natural medicines, as well as pregnancy supplement, Mamacare.
Symbion is one of Australia’s largest pharmacy wholesalers, owned by the listed company EBOS Group, it provides products and services to over 3,500 pharmacy customers across Australia. The business has 10 warehouses located across the country and coordinates daily deliveries to pharmacies through longstanding relationships with delivery partners.
Symbion’s strong retailer customer base represents a viable addressable audience for Bod and raises hopes that Bod’s products will achieve greater market shares across pharmacies and specialty retailers.
From trial to commerce
If its phase 1 clinical trial is successful, Bod will look to develop a unique, standardised, reproducible and patent protected cannabis product which can be sold domestically, internationally or licenced to large-scale pharmaceutical companies.
Following phase 1, Bod is then likely to move to phase 2 clinical trials sometime next year whereby its product will be evaluated for specific indications such as chemotherapy-associated nausea and vomiting, multiple sclerosis, epilepsy, anti-inflammation treatment and anxiety.
“The company has achieved a number of milestones to date, including product formulation, patient recruitment and granting of all necessary regulatory approvals, and look forward to first patient visits today,” said Ms Patterson.
“As the trial progresses, Bod will continue to explore ways in which we can leverage our cannabis product innovations through partnerships and collaborations with key researchers. Further, the Company will continue to progress opportunities to sell, licence and distribute our finished sublingual wafer product,” added Ms Patterson.