Avecho Biotechnology Limited (ASX:AVE) has commenced dosing in a cohort of 16 healthy volunteers for its Australian Phase I pharmacokinetic (PK) study designed to characterise the absorption profile of cannabidiol (CBD) from its TPM-enhanced pharmaceutical CBD soft-gel product.
Avecho’s oral CBD formulation has already been demonstrated to increase the oral bioavailability of CBD in animal models when compared to standard CBD preparations.
This Study will demonstrate the absorption profile of the Company’s CBD formulations in humans for the first time and support Avecho’s strategic focus of developing pharmaceutical CBD products that leverage its proprietary TPM formulations.
The Study will assess the safety and absorption profile of Avecho’s 75 mg CBD soft-gel product, which has been developed and manufactured by Catalent Inc at its facility in Florida, US. Subjects in the study will receive two separate doses (75 mg and 150 mg) over a period of two weeks.
Healthy volunteers received their first dose at the CMAX Clinic in Adelaide on Saturday 2 October 2021, with no adverse events of concern reported. The second dose will commence on the 9th of October.
Blood samples will be analysed for CBD, TP, T2P and tocopherol (the components of Avecho’s TPM formulation) and the results used to investigate a range of standard pharmacokinetic variables. These include the maximum drug concentration in the blood (Cmax), the time taken to reach the maximum drug concentration (Tmax) and the total drug exposure over time (AUC).
Avecho CEO, Dr Paul Gavin, said: “We are delighted to commence this Study and complete the first dose in the cross-over. While we won’t have the CBD absorption results until later in the year, it is already good to see that the CBD dose was well tolerated by subjects.“
The Study has been designed to form a key piece of a future regulatory submission, as well as to inform ongoing research and development for Avecho’s CBD product portfolio and potential commercial partnerships in this space.
High level results are expected in December 2021, which will mark a significant milestone for the programme.
