The manufacture of the required cannabis wafers for clinical trials is set to commence in the coming weeks, with phase I clinical trials to commence shortly thereafter.
Bod chief executive officer Jo Patterson said: “Having finalised the formulation of Medicabilis in WaferiX form we have another major milestone for the company as it tracks towards the commencement of its phase I clinical trial program.”
The sublingual cannabis wafer is a unique combination of Bod’s proprietary ECs315 cannabis extract and iX Biopharma’s ‘WaferiX’ technology.
The formulated product, containing Bod’s proprietary cannabis extract, which has been freeze dried into a sublingual wafer, can be placed under the patient's tongue.
The wafer dissolves rapidly and releases contained active compounds for efficient absorption.
The upcoming phase I clinical trial will test the safety, tolerability and pharmacokinetics of Bod’s proprietary Ecs315 extract presented as a sublingual wafer.
Aiming to sell or license to major pharmaceutical companies
A positive trial outcome will leave the company with a unique, patent protected, standardised and reproducible cannabis product which may be sold or licenced to major pharmaceutical companies.
Meanwhile, the company is expected to receive Swiss herbal extracts company Linnea SA’s proprietary cannabidiol (CBD) in MCT oil in the coming weeks.
Following delivery, Bod will make the oil available to patients through the Therapeutic Goods Administration (TGA) Special Access Scheme Category B.
Bod's proposed packaging for the ECs315 CBD extract in MCT oil
Patterson added: “We look forward to receiving our initial order of cannabis oils into Australia and ensuring that it is prescribed and distributed, not only to those that require it, but also in a fully transparent manner.”