Emyria Ltd (ASX:EMD) has launched its first product EMD-003 – a cannaboid for mental health – and is confident its drug development program will allow it to accelerate drug registration.
The company has identified that 60% of its patient and 4.8 million Australians are impacted by mental health issues which cost the Australian health system $60 billion per year, so there is a market opportunity in a cannabis product for mental health – particularly with the increase in demand for new treatments during the COVID-19 pandemic.
Emyria has filed the IP, the design of pivotal registration trials are underway and conversations with supply partners are also underway.
Emyria’s model can accelerate drug registration.
Medicinal cannabis in Australia
Currently, there are 52 medicinal cannabis products available in Australia and the products are unregistered, meaning they are only available to patients via Special Access Schemes, Authorised Prescriber programs or clinical trials.
To date, only one product is registered and available via routine prescription (Epidyolex) and only for rare forms of epilepsy with an estimated prevalence of 1 in 20,000-40,000.
The company plans to register the cannabinoid-based medicine for a specific mental health indication with the Therapeutic Goods Administration’s (TGA) Australian Register of Therapeutic Goods (ARTG).
The company also has comparative advantages in product development.
Drug registration and development advantage
Emyria believes it has an advantage to accelerate drug registration via its end-to-end drug development program which will generate clinical evidence for the safety and efficacy of its new cannabis product for mental health applications.
The company also has unique access to large patient populations across its clinical trial network, as extensive data which has provided dose-response insights, safety data, patient stratification, strategic trial and product development insights.
Emyria’s patient care model also supports ongoing evaluation monitoring and evaluation of product development.