Emyria Limited (ASX: EMD) who investigating new treatments for mental health and select neurological conditions, has entered into a binding research study agreement with charity Reach Wellness to manage a pivotal observational study designed to evaluate the effectiveness of Emyria’s MDMA-assisted therapy (MDMA-AT) program, together with a support program managed by Reach Wellness, for first responders with PTSD.
According to the Emyria this agreement underscores Emyria's leadership in the evolving field of MDMA-AT research and marks a significant step forward in addressing the unique care and support requirements of first responders suffering from PTSD.
Emyria is at the forefront of mental health treatment innovation, having commenced community-based MDMA-assisted therapy trials in October 2023 1. Its lead psychiatrist has since achieved Authorised Prescriber status 2, becoming one of the few services nationwide authorised and capable of providing MDMA-assisted therapy for PTSD under the rigorous regulatory oversight and requirements established by the TGA. There are risks associated with the use of MDMA, which are set out at the end of this announcement.
As part of its commitment under the research study agreement, Reach Wellness has embarked on a vital fundraising effort to cover all treatment and follow-up costs for an initial cohort of 50 suitably screened first responders who are struggling with PTSD and eligible for MDMA-AT. This initiative represents a substantial pledge towards mental health care (an estimated $1.5m) and will help evaluate the potential of new therapies for those who serve and protect us.
The Emyria-Reach Wellness initiative arises in response to the growing national mental health challenge. Over a million Australians have PTSD 3 with first responders and veterans showing a 60% higher incidence rate 4. Traditional treatments may not provide relief for all sufferers, highlighting a need for innovative approaches. MDMA-AT has shown promise as a potential treatment for PTSD in multiple Phase 3 clinical trials conducted in the USA 5 and from July 1st 2023, MDMA can be legally prescribed for PTSD by specialist psychiatrists who have obtained Authorised Prescriber status from the TGA 6 and who can also demonstrate a capability to provide supportive therapy.
The Emyria and Reach Wellness partnership aims to evaluate the Real-World efficacy and cost benefits of Emyria’s MDMA-AT model combined with a tailored support program for an initial cohort of 50 first responders. Consequently, the research study agreement is expected to directly support engagement with major Health Payers while contributing to a broader understanding of these new treatments.
The support from Reach comes as Emyria is in the process of enhancing its capacity for Real-World research by expanding its clinical facilities and increasing its pool of Authorised Prescribers and trained therapists. These investments improve Emyria’s ability to develop a scalable and commercially viable MDMA-AT model while Reach’s support increases the Company’s potential to evaluate new mental health solutions on a wider scale.
Reach Wellness founder, Rick Green: “First responders keep our communities safe and functioning both locally and overseas. However, these roles can be highly stressful both physically and mentally as is evident by the high rates of PTSD and other mental health challenges.
“Reach’s mission is to fund research and care programs for those who help others first with the generous support of our donors.
“Emyria is one of the most well-prepared research organisations in Australia capable of evaluating MDMA-assisted therapy in real-world settings and we are excited to partner with them on this research program managed within a strictly controlled regulatory environment.”
Emyria CEO, Dr Michael Winlo said: “We are delighted to partner with Reach Wellness to help improve the treatment and support of Australia’s first responders who are impacted by mental health conditions like PTSD.
“We are committed to evaluating the impact of emerging approaches like MDMA-Assisted Therapy and the team at Reach shares our vision and is committed to backing it financially, with the support of its generous donors.”
A binding research study agreement has been entered into between the parties to advance the trial. Material terms are outlined on Page 4.
A comprehensive fundraising campaign is now underway, managed by Reach Wellness, to raise the estimated $1.5m required to cover all treatment and study costs for the initial 50 participant cohort.
