Synthetic cannabinoid-based product developer Emyria (ASX: EMD) has been given the green light to proceed with a Phase 3 clinical trial of its first ultra-pure CBD candidate, EMD-RX5, in a major milestone for the company.
The trial, supported by Emyria’s clinical service subsidiary Emerald Clinics, is aimed at assessing the efficacy of two dose strengths of EMD-RX5 to treat the psychological distress of patients suffering from chronic pain.
A successful trial will support Emyria’s registration of EMD-RX5 with the Therapeutic Goods Administration as a Schedule 3, over-the-counter treatment.
The first site approved by the Human Research Ethics Committee for the trials is the Hatherley Medical Centre in Perth, with the program being led by Dr Zachary Nathan.
Other sites will be added across Australia supported by Emerald Clinics, which will help to recruit patients for the study of 300 participants aged between 18 and 70.
Emyria’s managing director Dr Michael Winlo says the Phase 3 trial is a ‘significant milestone’ for the company.
“We believe a successfully registered over-the-counter medicine in this category represents a large opportunity for Emyria to address a major unmet health need,” he says.
“We look forward to further evaluating EMD-RX5 for other indications and registration opportunities while we continue to expand our ultra-pure cannabinoid product portfolio, advance our MDMA-inspired drug discovery program and pursue commercialisation opportunities.”
Emryia is a clinical stage biotech company supported by Australian rich-lister Andrew ‘Twiggy’ Forrest. The company is among the many investments targeted by new biotech venture capital group Tenmile which this week announced a $250 million investment from Andrew and Nicola Forrest’s private company Tattarang. The Forrests have identified Tenmile as a critical force in fast-tracking the development of ‘life-changing’ health technology across many fields.
Elmyria has developed EMD-RX5 to target psychological distress such as mild anxiety, sleep disturbance and gastrointestinal upset. It says the problem affects up to 11 per cent of all Australian adults, and a higher percentage of those living with chronic disease.
Emyria shares surged more than 18 per cent on today’s announcement before easing back by late morning.
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