Emyria Ltd (ASX:EMD) is gearing up for phase one, in-human trials of its proprietary, ultra-pure CBD capsules later this quarter.
The data backed drug development and care delivery company plans to assess the safety and bioavailability of its CBD formulation against Epidyolex — the only Therapeutic Goods Administration (TGA) and Food and Drug Administration (FDA) registered CBD medicine.
Emyria’s proprietary formulation, named ‘EMD-RX5’, is expected to support multiple Real-World Evidence-guided registration programs for the company, including:
- An over-the-counter, low-dose CBD treatment for the temporary symptoms of psychological distress (the ‘EMD-003’ program) and;
- A CBD treatment for the relief of symptoms associated with Irritable Bowel Syndrome (IBS) (the ‘EMD004’ program).
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.
The formulation is expected to be a treatment candidate for multiple clinical indications.
What’s next?
Phase one clinical trials on EMD-RX5 will kick off this quarter with recruitment activities.
The study will take place at CMAX Clinical Research — a leading facility for phase one trials.
Once phase one is complete, EMD plans to move to a pivotal phase three trial for the drug candidate.
Good manufacturing practice (GMP)-grade production has also commenced on the CBD capsules to support the upcoming trials, which are required for the TGA to consider EMD-RX5 for classification as an over-the-counter medicine for psychological distress.
This would see the drug candidate identified as a Schedule 3 substance under the TGA’s national medicines classification system.
Thanks to the headway made to date, Emyria is targeting its first TGA submission by the end of 2022.
Further clinical applications of, and global registration opportunities for, EMD-RX5 are in development and more information will be provided to the market as this program advances.
“Treatment potential for multiple indications”
Speaking to the development, Emyria managing director Dr Michael Winlo said: “We’re delighted to commence phase one 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 (ETR: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 US for large unmet needs.
“We look forward to providing more updates on our phase one and phase three clinical trials as well as additional registration plans in the near term.”