Cosmetics and natural medicines company Bod Australia (ASX: BDA) has achieved what it calls a “world-first” in the clinical trial of its proprietary phytocomplex cannabis extract ECs315, showing that cannabidiol (CBD) can be delivered into a patient’s bloodstream using its patented wafer system.
The company launched the phase one clinical trial in July, aiming to test the safety, tolerability and pharmacokinetics (how a drug is absorbed, distributed, metabolised and excreted in the human body) of ECs315.
Reporting to the market today, Bod said it had successfully dosed the extract in a sublingual wafer, meaning the wafer is dissolved under the tongue.
According to the company, this is the first time in the world that pharmacokinetics of a full plant cannabis extract has been evaluated under blinded clinical trial conditions, where neither the patient nor clinician know if they are using the active drug or the placebo.
Bod chief executive Jo Patterson described the results of the clinical trial to date as “outstanding”.
“It is a major leap forward in developing a proprietary sublingual wafer that could have broad commercial appeal,” she said.
The next stage of the clinical trial involves Bod testing the absorption rate of its patented wafer, when compared to the ECs315 cannabis extract in its currently available oil form.
The wafer will also be tested against a competitor’s product currently available on the Australian market.
All phases of the clinical trial are expected to be completed for the end of this year.
“Following success with the clinical trial, Bod will retain the rights to a unique, easily reproducible finished product with worldwide patent protection, underpinned by a global brand we are developing,” Ms Patterson said.
She also noted Bod’s multiple pending commercial, clinical and corporate developments, saying the company expected a “steady stream of updates in the coming weeks and months”.
“We are also broadening our use of the proprietary WaferiX technology and pursuing additional research initiatives which test the ECs315 extract on specific conditions such as post-chemotherapy nausea and vomiting,” Ms Patterson added.
Bod developed its wafer with the aid of products and technology accessed through its exclusive partnership deals with Singaporean pharmaceutical company iX Biopharma (SGC: 42C) and Swiss Botanicals extracts manufacturer Linnea SA.
By early afternoon trade, Bod’s shares had climbed 9.35% to $0.585.