Emyria Limited announced that Phase 1 clinical trials are to commence for its leading ultra-pure CBD drug candidate, referred to as EMD-RX5. EMD-RX5 is a proprietary, highly bioavailable oral CBD formulation developed to meet the strict product purity requirements of both the TGA in Australia and the FDA in the USA. EMD-RX5 is expected to be a candidate treatment for multiple clinical indications.

Pure CBD is structurally and biochemically identical to plant-derived CBD [1] and also: tasteless and odourless; highly stable at room temperature and; free from the impurities associated with plant-derived CBD (such as heavy metals, pesticide residues and multiple other cannabinoids including undetectable levels of THC). The Phase 1 clinical trial of EMD-RX5 will be conducted at CMAX Clinical Research (CMAX) following ethics approval and will assess the safety and bioavailability of EMD-RX5 compared to Epidyolex - the only CBD-only medicine formally registered with the TGA and the FDA. Recruitment is expected to commence in first quarter of 2022.

Recently completed animal studies evaluating EMD-RX5 suggest that it has improved bioavailability compared to Epidyolex meaning it may deliver more CBD to a patient at equivalent prescribed doses. Improved bioavailability means a higher active drug exposure is achieved for patients at lower ingested doses.