Emyria Limited (ASX:EMD) is partnering with Mind Medicine Australia to co-develop a gold-standard and data-driven clinical model for the safe provision of psychedelic-assisted therapies in Australia.
The partnership will also develop a national clinical evidence registry to support research into the safety, effectiveness and cost benefits of psychedelic-assisted therapy enabled by Emyria’s RealWorld Evidence (RWE) data platform.
It will leverage on Emyria’s experience with unregistered medicines for patients with unmet needs across its national network of clinics – Emerald Clinics.
Creating unique data registry
Emyria’s managing director Dr Michael Winlo said: “We’re delighted to support Mind Medicine Australia by developing a scalable psychedelic-assisted therapy care model for patients suffering from treatment-resistant post-traumatic stress disorder, treatment-resistant depression and substance abuse.
“Emyria has unique expertise caring for patients with unmet needs while also generating high-quality clinical evidence using our RWE data platform.
“This partnership has the potential to expand the therapeutic options available for our patients with unmet needs while also creating a unique data registry that can accelerate treatment development and registration.”
New care models needed
Mind Medicine Australia chairman Peter Hunt AM said: “Mental health is a growing global health concern and new care models are needed.
“Psychedelic-assisted therapies show incredible promise but further high-quality clinical evidence is needed to demonstrate their effectiveness.
“This is why we’re excited to work with Emyria, who can help us develop a model of care that provides patients safe access to these promising treatments.
“The partnership will also allow us to generate high-quality data, which can inform ongoing research and development efforts and guide evidence-based access to these therapies for patients in need, where appropriate.”
Terms of the partnership
Under the terms of the partnership, Emyria will design a care model describing how psychedelic-assisted therapies could be delivered safely to patients with major mental health concerns, pending the successful rescheduling of psilocybin and MDMA by Australia’s Therapeutic Goods Administration (TGA).
Mind Medicine Australia will provide access to its international network of experts, clinical trainers and treatment model strategies.
Initial focus will be specialist-directed use of MDMA assisted therapies for treatment-resistant post-traumatic stress disorder and psilocybin assisted therapies for treatment-resistant depression.
It will draw on pivotal research conducted recently in North America and Europe.
Emyria will also apply its remote monitoring technology and lead the construction of a longitudinal data registry.
The registry will collect real-world clinical data on diagnoses, concomitant medications, dosing information and patient responses to psychedelic-assisted treatments as measured using validated clinical and patient-reported endpoints.
This data will support ongoing research into the safety, effectiveness and cost benefits of psychedelic-assisted therapies for major mental health concerns compared to current alternatives.
Both parties will contribute in-kind to the partnership.
Commercial opportunities that may arise from the development of these therapies will be negotiated on a case-by-case basis.