Emyria Ltd (ASX:EMD) welcomes a TGA-commissioned Independent Expert Panel report evaluating the therapeutic value, benefits and risks of methylenedioxymethamphetamine (MDMA) and psilocybin for the treatment of mental health conditions.
The data-backed care delivery company is focused on accelerating drug development and improving care. EMD has multiple treatments in its pipeline, utilising cannabinoids, MDMA and psilocybin in its efforts to tackle neurological issues such as mental illness and PTSD, chronic pain and irritable bowel syndrome.
Emyria is currently awaiting ethics approval for its first psychedelic-assisted program, EMDMA-001, which will leverage Emyria’s existing clinical data, infrastructure and trained therapists.
The company seeks to assess the safety, efficacy, and cost-effectiveness of MDMA-assisted psychotherapy for treating patients with Post Traumatic Stress Disorder (PTSD).
Read: Emyria makes strides in MDMA analogue screening program with preliminary analysis
Opportunity to lead development
Emyria is already in a non-exclusive partnership with Mind Medicine Australia – which led the initial rescheduling application with the Therapeutic Goods Administration (TGA) – to develop a scalable, evidence-based clinical delivery model for MDMA-assisted therapy.
“The Independent Expert Panel has reviewed high-quality published research into MDMA and psilocybin and concluded that, with appropriate clinical oversight and psychological support, these treatments are reliably safe and effective for certain patients,” Emyria’s managing director Dr Michael Winlo said.
“We are encouraged by the approach of the report, and its conclusions, and believe it will encourage further research and investment into these treatments to help develop evidence-based ways they can be scalably and safely administered to patients.
“With Emyria’s expert partners, national clinical network and data infrastructure, we believe there is a growing opportunity for Emyria to help lead in the development of MDMA-, psilocybin-, and other psychedelic-assisted therapies for patients with major mental health concerns.”
Findings support Emyria clinical model
The TGA report found that MDMA and psilocybin were well tolerated in supervised trials and that statistically significant differences for the treatments were observed between both inactive and active treatments.
Emyria’s EMDMA-001 phase IIB protocol ensures that patients are treated in a “closely supervised setting” and provided “intensive professional support”, which follows guidance from the Expert Panel Report.
The expert panel was formed by the TGA Scheduling Delegate to assist in determining whether to down-schedule MDMA and psilocybin from Schedule 9 (prohibited drugs) to Schedule 8 (controlled drugs).
The full report will now be considered by the Advisory Committee of Medicines Scheduling at the November 3, 2021, meeting with the TGA’s final decision expected to be published in the first week of December 2021.
Report clinches year of regulatory success
This financial year Emyria gained TGA approvals for its remote digital health monitoring technology and is working to secure registration for its medicinal cannabis drug products.
“This is an essential part of Emyria’s success that differentiates us from other medical cannabis or psychedelic medicinal drug companies,” Emyria chairman Dr Stewart Washer said in Emyria’s 2021 annual report.
“We provide safe and tested avenues for patients to try promising new treatments - and we develop them too – with the best clinical evidence systems and support teams in place. Our patients receive the personalised care they truly deserve, with an opportunity to contribute to, and benefit from, Emyria’s growing body of clinical data and insights.”
Emyria raised $8.4 million this financial year with tax incentives and grants delivering an additional $1.8 million. This capital will facilitate steady growth across Emyria’s services – clinical services under Emyria care, drug development and evidence portfolio under Emyria Data, and ongoing research and development under Emyria Treatments.
