Emyria (ASX:EMD) has announced the pending commencement of phase 1 clinical trials for its leading ultra-pure CBD drug candidate.
The company said EMD-RX5 is a highly bioavailable oral CBD formulation developed to meet the strict product purity requirements of both the TGA US FDA. It said EMD-RX5 is expected to be a candidate treatment for multiple clinical indications.
The Phase 1 trial 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 the first quarter of 2022.
Emyria said it is targeting its first TGA submission by the end of 2022.
According to managing director Dr Michael Winlo, “We’re delighted to commence Phase 1 human clinical trials for our proprietary ultra pure CBD formulation, now referred to as EMD-RX5.
"EMD-RX5 is the designated formulation supporting Emyria’s first drug registration program guided by our proprietary Real-World Evidence - the EMD-003 program. Following our recent successful animal studies - comparing our formulation to Epidyolex - we also believe EMD-RX5 has the potential to become a registered treatment for multiple indications.
"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.
"We look forward to providing more updates on our Phase 1 and Phase 3 clinical trials as well as additional registration plans in the near-term.”