Emyria Ltd has safely dosed its first participant of its ethics-approved MDMA-assisted therapy (MDMA-AT) trial, EMDMA-001.
This is a significant milestone for the company and is the first dosing since the Therapeutic Goods Administration (TGA) descheduling of MDMA in July 2023. This milestone initiates both the active treatment phase of Emyria’s MDMA-AT program and the accumulation of real-world data to support further innovation and payer engagement.
The dosing was administered without any safety issues, marking what is believed to be a pioneering achievement for a private specialist clinic operating independently from both academic centres and public or private hospitals.
Notably, the milestone follows the demonstration that MDMA-AT for Post-Traumatic Stress Disorder (PTSD) was highly effective and safe in second Phase 3 clinical trial published by MAPS last month.
Emyria lead psychiatrist Dr Jon Laugharne said: "For individuals grappling with PTSD, the current treatment landscape can feel limiting. By initiating active MDMA-assisted therapy within an operational private clinic, as opposed to traditional academic settings, we aim to prioritise real-world patient well-being and learning in order to develop a viable delivery model that can scale.”
Emyria poised for leadership in emerging mental health therapies
The EMDMA-001 trial serves as a cornerstone for Emyria's Authorised Prescriber (AP) program for MDMA-AT. It provides Emyria's clinical team with an ethics-approved protocol, priming them for the rigorous demands of the AP program.
This places Emyria in a leadership position, as only a limited number of specialists currently satisfy the AP criteria.
As the trial has now transitioned to active treatment, it not only strengthens Emyria’s AP application but also starts to produce robust clinical evidence. This evidence further supports payer engagement and bolsters Emyria’s broader drug development initiatives.
A successfully launched AP program would subsequently expand patient accessibility to Emyria's innovative services.
With a history of caring for more than 10,000 patients and using real-world data at its Emerald Clinics, Emyria is well-positioned to play a significant role in the delivery of new mental health treatments, including MDMA-AT.
Multiple benefits
Emyria's Pax Centre features specialist oversight, a multidisciplinary team, and modern facilities to administer and assess MDMA-AT and other psychedelic-assisted therapies on a larger scale.
The Emyria model presents multiple benefits for both patients and investors:
- Wraparound Care: Emyria’s clinics offer comprehensive patient support ensuring personalised care is available before, during and after any innovative therapy.
- Data-Driven: Routine data capture allows for continual refinement of treatments and supports Emyria’s drug development programs.
- Diversified Revenue Streams: A balance between immediate clinical service revenues and the long-term potential of drug development offers investors stability and growth.
Targeting PTSD initially
As PTSD impacts an estimated one million Australians, the search for more effective treatments continues. MDMA-AT is currently under investigation in multiple Phase 3 clinical trials by the Multidisciplinary Association for Psychedelic Studies (MAPS) in the United States and shows potential as a PTSD treatment.
Emyria's own MDMA-AT trial aims to gather important Real-World Data and insights. These will not only support the initiation of Emyria's Authorised Prescriber program but also engage payers and help determine how Emyria's treatment model could be sustainably scaled.
Upcoming milestones:
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