Emyria Ltd (ASX:EMD) has received ethics approval for its phase one clinical trial of EMD-RX5, a proprietary, highly bioavailable oral formulation of ultra-pure CBD.

The Phase 1 trial is an important first step towards registration and will evaluate the bioavailability of EMD-RX5 as compared to Epidyolex – the only CBD medicine formally registered with the TGA and the FDA.

Commercial-scale GMP-grade manufacturing of EMD-RX5 is underway, ensuring a sufficient quantity of trial material for all trials required for registration.

“Proprietary formulation”

Emyria managing director Dr Michael Winlo said: “Uniquely amongst cannabidiol registration programs, Emyria’s Phase 1 clinical trial will directly compare the bioavailability of EMD-RX5’s proprietary formulation to the only successfully registered and reimbursed CBD oil in the global market to date, Epidyolex.

“EMD-RX5 is a high-performing and cost-effective CBD capsule with the potential to address multiple indications.

“Emyria’s first registration program is aimed at developing an over-the-counter, Schedule 3 treatment targeting the symptoms of psychological distress.

“This registration program was developed with insights from Emyria’s growing Real-World Data asset.

“EMD-RX5 also meets the strict requirements for product purity with both the TGA in Australia and the FDA in the USA, and as such, we believe it has potential to become a registered treatment for multiple clinical indications.

“I look forward to providing further updates on EMD-RX5 and our expanding cannabinoid portfolio in the near term.”

Phase one clinical trial

The Phase one clinical trial of EMD-RX5 will assess the safety and bioavailability of EMD-RX5 compared to Epidyolex 

Initially, EMD-RX5 is seeking registration as a low-dose, Schedule 3, ‘over-the-counter’ CBD treatment for the symptoms of psychological distress

EMD-RX5 dose form has the potential to support multiple TGA and FDA registration programs.

Notably, Emyria has completed the site initiation visit for EMD-RX5 at the leading Phase one clinical trial site, CMAX, with participant recruitment expected to commence imminently and dosing of EMD-RX5 to follow.

Furthermore, a provisional patent has been filed to cover Emyria’s proprietary formulation of EMD-RX5.