A phase one clinical trial of a sublingual cannabis wafer developed by Bod Australia (ASX: BDA) has highlighted the tolerability and superiority of the product and deemed it safe for human consumption.
The experimental trial – based around an open label, randomised, placebo-controlled, four-way crossover study of 24 healthy volunteers – was designed to determine the safety, tolerability, and pharmacokinetics of the proprietary cannabidiol (CBD) extract ECs315 administered as a single or multiple sublingual wafer and as an oil.
Preliminary trial results showed both products to be safe for human consumption after demonstrating “excellent tolerability characteristics”.
The results also showed that CBD from the wafer achieved faster absorption rates than in oil form and when compared to a competitor buccal product currently available in Australia and overseas.
Bod chief executive officer Jo Patterson said the bio-availability of the wafer could be of particular benefit to patients using cannabis as they could experience faster relief from their symptoms.
“We have shown that CBD through a sublingual wafer can be absorbed faster than CBD in oil and compares more favourably to another registered product on the market,” she said.
“We are now progressing regulatory, commercialisation and export activities to underpin a planned scale-up in production.”
Ms Patterson said safety data on Bod’s ECs315 and the sublingual wafer will assist penetration in markets such as Europe and the Americas, both of which offer significant potential sales upside.
Initial export orders of two wafer strengths are expected following relevant approvals.
The cannabis wafer is a unique combination of Bod’s proprietary ECs315 cannabis extract and WaferiX technology developed by late stage, Singaporean pharmaceutical company, iX Biopharma.
The formulated product freeze-dries the ECs315 into a sublingual wafer for administering to patients under the tongue, where it dissolves and releases contained active compounds for efficient absorption.
Bod is planning a phase two clinical trial to evaluate the wafers for specific indications such as chemotherapy-associated nausea and vomiting, multiple sclerosis, epilepsy, anti-inflammation treatment and anxiety.
Medicinal cannabis has become of the fastest growing, patient-demand industries after the Therapeutic Goods Administration moved to streamline the application process for medicinal cannabis patients last year.
A 2018 report by Market intelligence firm Prohibition Partners into the fledgling sector suggests it could expand to almost 200 times its current size within a decade.
It said the nation’s legal medicinal cannabis market – currently valued at more than $17 million annually – could balloon to $1.2 billion by 2024 and $3 billion by 2028.
At midday, shares in Bod were up 10.45% to $0.37.