Another Australian company eyeing the country’s low-dose, prescription-free cannabidiol market is clinical-stage biotech company Emyria Limited (ASX: EMD).
Last year we reported Australia’s Cann Group (ASX:CAN) inked an agreement in relation to Emyria’s EMD-003 drug development program for the potential registration of a Schedule 3, over-the-counter (CBD) medicine in Australia.
The latest news from Emyria doesn’t mention Cann Group at all, but is in relation to its EMD-RX5 Phase 1 Study. EMD-RX5 was previously referred to as the EMD-003 program.
The company announced it had commenced participant recruitment, screening and consenting, and expects first dosing to begin by the end of this month. The trial of EMD-RX5 will assess the safety and bioavailability of EMD-RX5 compared to Epidyolex, which is currently the only CBD-only medicine registered with Australia’s TGA and the USA’s FDA.
With EMD-RX5, Emyria is initially targeting TGA registration as an over-the-counter CBD treatment for the symptoms of psychological distress, which affects around 15% of Australians – perhaps even a higher proportion in more recent years given various events.
“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,” said Emyria Managing Director, Dr. Michael Winlo (pictured above).
Epidyolex is indicated for use as adjunctive therapy of seizures associated with Lennox Gastaut syndrome (LGS) or Dravet syndrome (DS), rather than psychological distress.
Beyond this Phase 1 trial, a Phase 3 clinical trial protocol required for registration has already been developed and is expected to commence immediately following this Phase 1 study, assuming the appropriate ethics approvals are secured. Emyria believes it can leap-frog a Phase 2 trial given its proprietary “Real World Data” has informed the selection of the target indication.
Emyria received ethics approval for its Phase 1 clinical trial of EMD-RX5 just a couple of weeks ago. It will be compared to Epidyolex in a crossover design with 12 healthy volunteers. The company says a provisional patent has been filed to cover EMD-RX5, and beyond psychological distress Emyria believes EMD-RX5 has the potential to become a registered treatment for multiple indications.