Emyria Ltd (ASX:EMD) is poised for growth in 2021, with the expansion of its clinical service subsidiary Emerald Clinics, clinical trial planning underway and a strong financial outlook to pursue drug registrations.
Earlier this month the company added a second consulting suite in Perth, doubling its capacity in Western Australia off the back of record patient appointments in January 2021.
The additional clinical capacity will support a wider range of clinical trials and will help deliver on the recently awarded Future Health Research and Innovation Grant.
This expansion will also help improve waiting times and allow more patients to be seen, improving the company’s proprietary data asset (Emyria Data) which reflects the real-world clinical experience of more than 3,000 patients on cannabinoid medicines.
Emyria also expanded in Victoria in February, opening a second clinic in Melbourne.
EMD-003 registration trials
Additional clinics will provide insights for Emyria Data which will inform the design and planning of pivotal drug registration clinical trials for the first drug program, EMD-003 - a cannabinoid medicine targeting unmet needs in mental health.
The company is seeking registration as a Schedule 3 medicine and aims to treat psychological distress and the symptoms of anxiety, depression and stress for certain patient populations.
Notably, Schedule 3 medicines are managed by pharmacists and available over the counter without a prescription from a doctor.
EMD-004 trial recruitment
The company’s other drug candidate EMD-004 is a cannabinoid-based medicine focused on treating symptoms associated with irritable bowel syndrome - a large unmet need.
IBS is common and affects around 3 out of every 10 people, however in Australia, there are no medicines designed specifically for the condition.
Emyria’s observational trial on IBS has ethics approval and recruiting is underway.
Openly remote monitoring platform
The company plans to support strategic development into its remote monitoring platform - Openly - with an application for Class II TGA registration submitted in the December quarter for the platform’s smartphone-led heart rate and heart rate variability measurement technology.
These vital sign measures are related to psychological distress which can be early signs of infection or mental health changes and could be important to the development of EMD-003.
Openly will play a central role in a recently awarded $880,000 grant from Western Australia’s Future Health Research and Innovation Fund, which is intended to boost Western Australia’s digital health infrastructure and capacity to manage future health challenges like COVID-19.
The grant's aims include evaluating the utility of advanced digital health monitoring in vulnerable patient populations, to improve engagement amongst aged and ethnic populations and to improve mental health evaluation and monitoring for those under remote care.
Openly will also support and monitor patients during the upcoming clinical trials.
Mind Medicine Australia partnership
The company is also working on a design care model describing how psychedelic-assisted therapies could be delivered safely to patients with major mental health concerns.
Mind Medicine Australia will provide the company access to its international network of experts, clinical trainers and treatment model strategies.
The model will start with psilocybin and MDMA-assisted therapies and draw on pivotal research conducted recently in North America and Europe.
Emyria will also apply its remote monitoring technology and lead the construction of a longitudinal data registry which will collect real-world clinical data on diagnoses, concomitant medications, dosing information and patient responses to psychedelic-assisted treatments as measured using validated clinical and patient-reported endpoints.
The data will support ongoing research into the safety, effectiveness and cost benefits of psychedelic-assisted therapies for major mental health concerns compared to current alternatives.
Strong financial position
In December, the company completed an oversubscribed $1.2 million placement to new strategic investors with the aim to accelerate the company’s drug development programs.
The investment increased the company’s cash position to around $5 million, meaning it is well supported heading into 2021.
Buoyed by this financial and operational strength, the company is focused on advancing the development and commercialisation of its treatments for mental health conditions and IBS and its Openly platform.