Avecho Biotechnology has begun participation in the CA Clinics Observational Study (CACOS) of medicinal cannabis products to test the performance of its oral CBD formulation in human patients.
Avecho’s formulation has been shown to increase the oral bioavailability of CBD in animal models and will be tested for the first time in humans in the CACOS study.
The company will use the study to gather feedback on how the product performs in patients currently using medicinal cannabis to treat a range of indications. Performance will be compared against commonly prescribed CBD formulations.
The CACOS study aims to recruit 3,000 patients nationwide through a network of medicinal cannabis prescribing clinics and will use questionnaires to examine the side effects, dosage response and treatment satisfaction of medicinal cannabis formulations on patients’ health.
Data generated will help shape the future development of Avecho’s pharmaceutical CBD products, while also exploring the potential for SAS-B prescribing.
CEO Dr Paul Gavin said: “The observational trial design allows the product to be used in a range of indications, which may prioritise specific indications for further development, or eliminate indications where the treatment is less effective.”
Gavin welcomed the TGA’s recent decision to down-schedule CBD, but said Avecho’s technology could boost absorption and help the industry demonstrate efficacy at the maximum dose of 150mg/day indicated by the TGA.
He added: “The down-scheduling of CBD is fantastic news for patients, but a 150mg dose is on the limits of efficacy for a range of indications. We believe increased bioavailability will be a key value driver that will positively differentiate our products in this growing competitive market.”
The CACOS study forms the companion piece to a Phase I clinical trial currently scheduled to begin towards the end of Q1 2021.
Recruitment for the CACOS study will begin immediately and continue throughout 2021.