Emyria Ltd (ASX:EMD) has secured an immediately available local supply of MDMA, the final component that allows patient dosing to commence for its MDMA-assisted therapy trial to treat post-traumatic stress disorder (PTSD).
The locally available MDMA will be supplied to Emyria through a collaboration with Mind Medicine Australia (MMA) and the Australian National University (ANU).
This supply ensures the company can commence its ethics-approved MDMA-assisted therapy (MDMA-AT) trial while it awaits Health Canada to approve a comprehensive MDMA shipment from Canada.
"The final component"
Emyria CEO Dr Michael Winlo said: "With our recent milestones, including the Pax Centre acquisition, our team's training and ethics approval, MDMA supply was the final component.
“We are grateful to MMA and the ANU for their support in securing an immediately available initial supply which ensures we can continue progress while we wait for our subsequent larger shipment from Canada pending approval from Health Canada.”
READ: Emyria completes Pax Centre acquisition to boost mental health care and drug development
Mind Medicine Australia chair and co-founder Peter Hunt AM said, "A primary mission at MMA is to catalyse and support research into the potential of psychedelic medicines to address unmet needs in mental health treatments.
"We're pleased to assist Emyria and believe that collaborative efforts like these position Australia at the forefront of global advancements in mental health research."
Huge PTSD treatment potential
The call for more effective PTSD treatments is underlined by the fact that around one million Australians develop PTSD each year and around 400,000 of those are potentially suitable for MDMA-AT.
This, along with Australia’s proactive regulatory environment, and Emyria's readiness, places the company in a favourable global position.
Further affirming the treatment's potential are results released last week from a second Phase 3 clinical trial on MDMA-AT for PTSD, undertaken by the Multidisciplinary Association for Psychedelic Studies.
Results included improved symptoms for 86.5% of participants in the MDMA therapy group, with 71.2% of participants no longer meeting the criteria for PTSD following treatment.
Psychedelics patient registry
Emyria trials will provide essential data to a novel national patient registry led by the Australian National University’s School of Medicine.
The registry aims to gauge the effectiveness and safety of psychedelic substances when used therapeutically for severe mental health conditions, including depression and PTSD.
It will aggregate and analyse real-world data from clinical practice involving MDMA and psilocybin. Emyria is committed to contributing to this work and anticipates that its trial results will offer crucial insights to the registry and set a benchmark for future studies.
ANU School of Medicine and Psychology professor Paul Fitzgerald said, "Australia's approach to regulated psychedelic use is unique and forward-thinking. Our collaboration with Emyria will help us to expand our knowledge base, capturing insights beyond the controlled environment of clinical trials.
"This partnership aims to deepen our understanding of the real-world impact of these therapies."