By Dr Michael Winlo, CEO and Managing Director of Emyria
The only thing more exciting for Emyria than the substantial milestones of the last 12 months?
The possibilities of the next 12 months.
It’s been a momentous year for the company, highlighted by a successful Phase One trial of our proprietary, Ultra-Pure cannabinoid-based formulation, EMD-RX5, aimed at treating psychological distress symptoms.
EMD-RX5, a capsule medication and dose form preferred by prescribers and patients alike, demonstrated excellent safety and bioavailability results compared to the only FDA and TGA-approved cannabinoid-based medication, Epidyolex®, which is an oil dose form.
As the year draws to a close, our Phase 3 trial is gearing up, and we look forward to sharing the progress and results of that trial in the first half of 2023 as part of our ongoing journey towards registration in Australia and overseas.
And EMD-RX5 is just one of the medications we are developing that are aimed at treating several unmet health needs within the community, such as mental health conditions, insomnia, irritable bowel syndrome, and more. In April this year, we launched our second capsule, EMD-RX7, with a Phase 1 clinical trial imminent. You can see the progress of all these projects on the front page of our website in an easy-to-follow timeline.
In addition, our MDMA-analogue program continues to yield fantastic results, with 140 analogues being shipped for screening and multiple preclinical programs underway to evaluate several promising clinical indications. The program, a collaboration with UWA, uses the base molecule of MDMA as inspiration for creating new compounds (or ‘analogues’) that can have the desired therapeutic effects with fewer unwanted side effects.
The program aims to create medications that can be used to treat severe neuropsychiatric conditions such as Post-Traumatic Stress Disorder and Parkinson’s disease.
But that’s not all:
- We published the most extensive study of its kind in the world into the safety and efficacy of medicinal cannabis, which demonstrated that it was safe and effective across a cohort of 4000 patients for at least two years
- Our work has been highlighted by the Australian, the Australian Financial Review, Sydney Morning Herald, The West Australian, ABC Radio, Nine Radio, Proactive Investor and many more.
- We established partnerships and/or collaborations with global leaders like the National Institutes of Health, Psychogenics and the Institute for Respiratory Health.
- And, of course, we continued to treat and learn from thousands of patients at our clinical network, Emerald Clinics.
All this work has been powered by our proprietary real-world data system, which enables us to begin and execute projects with more speed and efficiency than would otherwise be possible – as evidenced by our rapid progress to a Phase 3 trial of EMD-RX5.
Even more importantly, every project we undertake and advance is driven by the goal of relieving the impact of the many unmet medical needs within our community. We know a massive demand for new and improved therapies for the many conditions for which current medications are either inadequate, overly expensive or entirely unavailable.
Our mission is to meet those unmet needs, and 2023 promises to be the most significant step yet towards that goal.