November 22nd, 2020
Mind Medicine Australia partners with Emyria (ASX: EMD) to develop national care program and data registry for psychedelic-assisted therapies
- Emyria and Mind Medicine Australia to develop an evidenced based, best practice, model to support the safe and appropriate initiation, delivery and monitoring of psychedelic-assisted therapies in Australia
- 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 Real-World Evidence (RWE) data platform
- 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
- Partnership to leverage Emyria’s experience with unregistered medicines for patients with unmet needs across its national network of clinics – Emerald Clinics
Emyria Limited (ASX: EMD) (Emyria or the Company), a company that accelerates treatment development for patients with unmet needs, is pleased to announce a partnership 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.
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.”
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 the TGA (please see TGA note below). Mind Medicine Australia will provide access to its international network of experts, clinical trainers and treatment model strategies. The model will start with psilocybin and MDMA-assisted therapies and 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. The 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.
Mind Medicine Australia’s 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 accelerate the widespread adoption and availability of these therapies for patients in need.”
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.
Under Australia’s Therapeutic Goods Administration (TGA), psychedelic medications such as psilocybin and MDMA are currently Schedule 9 of the Uniform Scheduling of Medicines and Poisons (which deals with Prohibited Substances). Despite approvals being given by the TGA under the Special Access Scheme current State Government legislative restrictions in most States of Australia mean that they are only available via approved clinical research trials which include oversight by an institutional research ethics committee and careful monitoring and reporting of efficacy and safety outcomes.
There is an active rescheduling proposal before the TGA so that they can be more easily used as clinical therapies in medically controlled environments for the treatment of key mental illnesses. The rescheduling would move these medicines to Schedule 8 (which deals with Controlled Medicines), the same category as THC-containing cannabinoid medicines. For more information:https://www.tga.gov.au/consultation-invitation/consultation-proposed-amendments-poisons-standard-acms-accs-and-joint-acmsaccs-meetings-november-2020.
This announcement has been approved and authorised for release by the Board of Emyria Limited.
For further information on Medicine-Assisted-Psychotherapies, please visit the MMA website.
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