Emyria (ASX:EMD) has announced that participant recruitment, screening and consenting has commenced for the EMD-RX5 clinical development program.
EMD-RX5 is an ultra-pure, highly bioavailable cannabidiol (CBD) capsule. Emyria says it has the potential to become a registered treatment for multiple indications.
EMD-RX5 is the company’s first, proprietary cannabinoid-based medical treatment.
Emyria said it is initially seeking registration of EMD-RX5 with the TGA as a low-dose, Schedule 3, 'over-the-counter' CBD treatment for the symptoms of psychological distress.
It said a pivotal Phase 3 clinical trial protocol required for registration has already been developed and, pending successful ethics approval, is expected to commence immediately following the Phase 1 trial.
Emyria’s managing director Dr Michael Winlo said, “ Emyria’s first registration program is aimed at developing an over-the-counter, Schedule 3 treatment targeting the symptoms of psychological distress - a growing global mental health concern affecting about 15% of all adults in Australia alone and which currently has no over-the-counter treatment available.
"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 EMD-RX5 has the potential to become a registered treatment in additional markets and for multiple clinical indications.
"Since the EMD-RX5 clinical development program was developed with insights from Emyria’s growing Real-World Data asset, the Company is able to move quickly from Phase 1 through to a Pivotal Phase 3 clinical trial. 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.
"I look forward to providing further updates on EMD-RX5 and our expanding cannabinoid portfolio.”