Clinical stage biotech company Emyria Limited (ASX: EMD) has announced a collaboration with The Pax Centre (PAX), Australia’s leading multidisciplinary, psychiatrist-led clinical service specialising in complex trauma treatment.
The collaboration aims to develop a scalable care programme for the safe provision of MDMA-assisted therapy, in the community, for patients with treatment resistant PTSD. PAX will provide specialist psychiatrists, trained therapists, and facilities.
Emyria will manage clinical trial design, Real-World Data generation, data monitoring and MDMA supply following the recent securing of patient-ready MDMA.
The care programme will commence as an ethics-approved clinical trial (with Emyria as Sponsor) until PAX psychiatrists have obtained Authorised Prescriber status and a cost model has been developed. The care programme could support other specialist groups under licence.
PTSD is a significant mental health issue in both the United States and Australia. In the US, approximately 10 million people are estimated to suffer from PTSD with total excess economic burden costs estimated to be around $232.2 billion per year.
In Australia, approximately one million people are estimated to suffer from PTSD. Given around 30-50% of PTSD patients show resistance to standard treatment there has been increasing interest in novel treatment approaches.
MDMA-assisted therapy has shown promising results for patients with PTSD but
its use has been limited to research settings due to the extensive preparations required encompassing therapist training, clinical protocol design, facility preparation, data monitoring, and drug supply coordination.
As the burden of PTSD grows, the interest and demand for new treatment options increases amongst patients and specialists,” Managing Director, Dr Michael Winlo, said.
“Following the TGA’s recent decision to reschedule MDMA to a controlled medicine, we believe the demand amongst psychiatry groups for a safe, cost-effective, and evidence-based care program to deliver MDMA-assisted therapy in the community for suitably screened patients.
“Emyria is thrilled to collaborate with The Pax Centre, a leading psychiatric clinical service, to develop this care program. Our team looks forward to developing clinical protocols with their experts that may help patients with PTSD while generating Real World Data that can support ongoing program improvement as well as Emyria’s novel drug development programne.”
Starting from July 1st, 2023, the TGA’s Authorised Prescriber Programme in Australia
will allow patient access to MDMA-assisted therapy as a Schedule 8 controlled medicine. However, as stated by the Royal Australian and New Zealand College of Psychiatrists, “prescribing psychiatrists must demonstrate adequate training, evidence-based treatment protocols, patient selection, and monitoring to be approved to prescribe this therapy. Ongoing psychotherapeutic support is also essential for this treatment model.”
Emyria’s partnership with PAX aims to directly address these challenges by developing a scalable care programme for MDMA-assisted therapy that can be safely and cost-effectively administered to patients with PTSD through community psychiatry groups. Emyria will develop the clinical delivery and data monitoring protocols while PAX will provide specialists and trained therapists, and an appropriate facility to administer the therapy safely.
Emyria has already secured a supply of patient-ready MDMA.
Emyria believes a comprehensive clinical package (eg programme + drug supply) has the potential to be licensed to other specialist groups wishing to participate in the network to help support the nearly 500,000 Australian patients with treatment-resistant PTSD.
The Real World Data to be generated in this partnership will support ongoing care model improvements, crucial cost-effectiveness studies to support reimbursement and also Emyria’s active MDMA-inspired drug development program with partner the University of Western Australia.