- ASX-listed drug development and clinical services company Emyria Limited has launched a psychedelic-assisted therapy program with Mind Medicine Australia.
- The Company disclosed the EMDMA-001 program would address key challenges in MDMA-assisted therapy.
- Emyria also plans to explore other MDMA and psilocybin-assisted therapy programs to treat depression and substance abuse.
An innovative drug development and clinical services company Emyria Limited (ASX:EMD), announced the launch of a psychedelic-assisted therapy program, EMDMA-001, developed with partner Mind Medicine Australia.
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Emyria to initiate psychedelic-assisted therapy program
The EMDMA-001 program will target Post Traumatic Stress Disorder (PTSD). As a first step and pending ethics approval for the program, EMD will sponsor a major, independently monitored clinical trial under the EMDMA-001 program. The study will target treatment-resistant PTSD with evidence-based MDMA-assisted therapy.
EMDMA-001 has been modelled on a significant Phase 3 clinical trial developed by the Multidisciplinary Association for Psychedelic Studies (MAPS).
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A major priority of this first program is to support the evaluation of the long-term safety, efficacy, and cost benefits of MDMA-assisted psychotherapy. Such evidence is required for delivering psychedelic-assisted care in a safe, standardised, and scalable manner.
Other than EMDMA-001, the Company also intends to explore other MDMA- and psilocybin-assisted therapy programs for the treatment of depression and substance abuse.
It is noteworthy to mention that psilocybin-assisted therapy for the treatment of resistant depression and major depressive disorder and MDMA-assisted therapy for PTSD has been granted Breakthrough Therapy status by the US Food and Drug Administration (FDA).
Dr Michael Winlo, Managing Director of Emyria, commented-
EMDMA-001 program to focus on major challenges in MDMA
The Company also disclosed that the EMDMA-001 program would address major challenges encountered in MDMA-assisted therapy. Furthermore, novel research and specialised training are required for the method of administration of MDMA-assisted therapy.
In general, MDMA-assisted therapy involves three general stages:
Source: Copyright © 2021 Kalkine Media Pty Ltd (Source: EMD Announcement)
Some patients may also require repeating the cycles mentioned above, and a clinical service should be prepared for supporting patients through the entire experience and beyond.
Outlook: the way forward
- With Mind Medicine Australia, EMD is confident that it is uniquely positioned to deliver the requisite clinical services while also generating strong and ethically sourced clinical evidence to advance the field.
- The first cohort of trained therapists will graduate this month from Mind Medicine Australia’s therapist training course. EMD has already equipped a fit-for-purpose facility.
- The Company is finalising a protocol that is anticipated to be submitted to ethics shortly with all the required regulatory measures carefully observed.
Furthermore, Emyria will provide further updates as the program advances.
Stock Information: At AEST 11:28 AM, EMD shares were trading at AU$0.260, in line with the previous close.