Among other achievements, the ASX-lister also announced an MDMA-assisted therapy trial for post-traumatic stress disorder (PTSD), saw its clinical data platform validated by an NYSE-lister and raised A$5 million in a placement.
Moving ahead, Emyria continues to pursue drug registration for its cannabinoid-based drug development programs on psychological distress and Irritable Bowel Syndrome.
The drug development company ended the June quarter with A$6.5 million in the bank to fund its future operations.
Working across strategic fronts
Emyria managing director Michael Winlo said Emyria made “great progress” on a number of strategic fronts in the June quarter.
“We have advanced our lead drug registration programs, EMD-003 and EMD-004, and filed additional patents to protect our use of cannabinoids for our target indications.
“A Real World Evidence study with IQVIA helped validate Emyria’s proprietary clinical data and reveal that our care models significantly reduce opioid use amongst our most opioid-dependent patients.
“Our remote monitoring smartphone application - OPENLY - achieved a Class IIa medical device registration with the TGA demonstrating our commitment to registered products and treatments with major regulators.
“We revealed how we are applying our evidence-generating care model to the emerging field of psychedelic-assisted therapy by Sponsoring an MDMA-assisted psychotherapy clinical trial for severe Post-Traumatic Stress Disorder.
“The study will run with partners Mind Medicine Australia and help us develop an evidence-based and scalable care model for the Australian context.”
Throughout the June quarter, Emyria made progress across three of its treatment product portfolios.
Notably, the drug development company remains on track to deliver one of the first registered Schedule 3, over-the-counter medicines in Australia
EMD-003, a cannabinoid formulation targeting psychological distress, has engaged with the Therapeutic Goods Administration to get feedback on its proposed indication.
Now, a multi-site trial is set to kick off next quarter, with the associated costs already factored into Emyria’s cash position.
In addition, the ASX-lister has filed additional patents that support the use of cannabinoid medicines to treat irritable bowel syndrome (IBS) after reviewing its own clinical data.
Essentially, Emyria’s patents, supporting its IBS-targeting MD-004 cannabinoid, cover:
- CBD-only formulations which could support a Schedule 3, over-the-counter registration program in Australia; and
- CBD and THC containing formulations that could support higher Schedule applications and position the product to pursue global registrations.
Finally, Emyria and Mind Medicine Australia announced a phase two, open-label clinical trial of MDMA-assisted psychotherapy for severe PTSD, known as EMDMA-001.
The trial will be fully sponsored by Emyria and run out of Emyria’s fit-for-purpose clinic in Melbourne before expanding to other sites.
Ultimately, EMDMA-001 will leverage Emyria’s clinical infrastructure and data capture technology to generate high quality, Real-World Evidence to inform future development.
Consultant Psychiatrist, Dr. Eli Kotler was appointed as the principal investigator for EMDMA-001 and will oversee the clinical governance for the clinical trial.
In early June, Emyria also revealed that clinical data from one of its personalised care plans for opioid users has been validated in a world-first data linkage project.
The ASX-lister is evaluating whether a treatment plan that involves care at its clinical services arm and a cannabinoid formulation can relieve a patient’s reliance on opioid medications to treat their chronic pain.
Promisingly, together with contract research monolith IQVIA (NYSE:IQV) and analytics firm NostraData, Emyria was able to validate its proprietary clinical data with a recent dispensing study.
Essentially, the validation indicates, on average, that opioid consumption reduces after a patient starts care at Emyria’s Emerald Clinics following 12 months of steady-state opioid use.
Turning to its digital health portfolio, Emyria received an Australian-first, Class IIa software-as-a-medical-device registration with the TGA for its Openly smartphone application.
This means Openly is now recognised as capable of providing medical-grade heart rate, heart rate variability and atrial fibrillation remote monitoring using only a smartphone camera.
Ultimately, Openly can facilitate medical-grade monitoring and open up further opportunities for Emyria to operate in both the telemedicine and consumer healthcare markets.
What’s the outlook?
Moving into the September quarter, Emyria continues to pursue drug registration for its cannabinoid-based drug development EMD-003 and EMD-004 programs, which will involve clinical trials using unique dose forms for the target indications.
In the meantime, Emyria will continue to evaluate Food and Drug Administration pathways for other unique cannabinoid medicines as it continues to extend its evidence-generating care model into psychedelic-assisted therapies.
It’s hoped this will help develop scalable and evidence-based psychedelic-assisted therapy programs to treat major mental health illnesses.