- Emyria (EMD) is set to begin phase one clinical trials of its ultra-pure CBD drug candidate, EMD-RX5
- The phase one trials will assess the safety of EMD-RX5 compared to Epidyolex, the only CBD-only medicine formally registered with the TGA and the FDA
- Emyria is now evaluating other proprietary cannabinoid formulations and dose forms that may be suitable candidates as additional drug development programs for its treatment pipeline
- Recruitment for the trial is expected to begin in the first quarter of 2022
- Emyria is up 3.41 per cent, trading at 45.5 cents
Emyria (EMD) is set to begin phase one clinical trials of its ultra-pure CBD drug candidate, EMD-RX5.
EMD-RX5 is an oral CBD formulation developed to meet the strict product purity requirements of both the TGA in Australia and FDA in the US. The drug is a candidate treatment for multiple clinical indications, like psychological distress and irritable bowel syndrome.
Pure CBD is structurally and biochemically identical to plant-derived CBD, while being tasteless and odourless and free from the impurities associated with plant-derived CBD.
The phase one trials will be conducted at the CMAX Clinical Research following ethics approval to assess the safety of EMD-RX5 compared to Epidyolex – the only CBD-only medicine formally registered with the TGA and the FDA.
Previous studies have suggested EMD-RX5 has improved bioavailability compared to Epidyolex, meaning it may deliver more CBD to a patient at equivalent prescribed doses.
Emyria’s Managing Director Michael Winlo said the company is delighted to commence Phase 1 human clinical trials for its proprietary ultra-pure CBD formulation.
“Given the speed and success of developing EMD-RX5, and ongoing insights provided by Emyria’s RWE, Emyria is now evaluating other proprietary cannabinoid formulations and dose forms that may be suitable candidates as additional drug development programs for our expanding treatment pipeline targeting registration in Australia and the USA for large unmet needs,” said Dr Winlo.
Recruitment for the trial is expected to begin in the first quarter of 2022.
Emyria was up 3.41 per cent, trading at 45.5 cents at 3:20 pm AEDT.