Avecho Biotechnology has received ethics approval for a Phase 1 clinical trial to characterise the absorption profile of CBD in 16 healthy volunteers.
The study will measure the safety and absorption profile of Avecho’s enhanced CBD product developed with its vitamin e-based proprietary drug-delivery system TPM.
The company said its oral CBD formulation has already been shown to increase the bioavailability of CBD in animal models when compared to standard preparations.
It said increasing the absorption of cannabinoids will support the development of differentiated CBD products and potentially reduce costs for patients.
The study will compare the absorption of CBD after consumption of soft-gel capsules at 75mg and 150mg doses, chosen to align with the TGA’s dosing requirements in its decision to down schedule CBD to an over-the-counter medicine late last year.
The company is already participating in the CA Clinics Observational Study (CACOS), Australia’s largest running observational study of medicinal cannabis products in patients, to gather real-world feedback on the product’s efficacy for a range of indications.
Timing for dosing the Phase I trial is anticipated to be early Q3. Avecho is now planning a larger development program beyond the Phase I study, including the clinical indication that will be targeted in a future pivotal clinical trial, and the regulatory, clinical and safety studies needed to submit a dossier to the TGA for product registration.
Avecho CEO Dr Paul Gavin said: “[This] is the first step toward our primary goal of developing differentiated CBD products for pharmaceutical registration.
“We are focused on producing a high-quality product that meets regulatory requirements for a pharmaceutical product. Consequently, the chemistry, manufacturing and control requirements are extensive – and something we are carefully executing to ensure we are successful.”