EMDMA-001 has been modelled on a major Phase III clinical trial developed by the Multidisciplinary Association for Psychedelic Studies (MAPS).
Emyria Ltd (ASX:EMD) and partner Mind Medicine Australia have launched the EMDMA-001 psychedelic-assisted therapy program targeting sufferers of treatment-resistant post-traumatic stress disorder (PTSD).
As a first step, and pending ethics approval, Emyria, an innovative drug development and clinical services company, will sponsor a major, independently monitored, clinical trial targeting treatment-resistant PTSD with evidence-based MDMA-assisted therapy.
A key priority of this first program is to help evaluate the long-term safety, efficacy and cost benefits of MDMA-assisted psychotherapy.
Such evidence is needed, along with fit-for-purpose clinical infrastructure and trained therapists, in order to deliver psychedelic-assisted care in a safe, standardised and scalable way.
Pending successful ethics review and the finalisation of all logistics, EMDMA-001 will begin with a Phase II, open-label clinical trial of MDMA-assisted psychotherapy at Emyria’s fit-for-purpose clinic in Melbourne before expanding to other sites.
EMDMA-001 will utilise specially-trained psychotherapists graduating from Mind Medicine Australia’s first Certificate in Psychedelic-Assisted Therapy (CPAT) training program at the end of this month.
Growing interest in psychedelics
Managing director Dr Michael Winlo said: “There is growing international interest in the promise of psychedelic-assisted therapies for treating our most challenging mental health conditions.
“However, the care model and the drug intervention are intrinsically linked – this means any treatment will require a properly prepared and equipped clinical service – including specially trained clinicians and therapists.
“We also require more robust clinical evidence to guide future innovation and development in this space.”
Novel research and specialised training are needed because of the way MDMA-assisted therapy is delivered. The treatment is unlike traditional psychotherapy or psychopharmacology and is deeply intertwined with pharmacological intervention.
Emyria also plans to further explore other MDMA- and psilocybin-assisted therapy programs in treating disorders such as depression and substance abuse.
Positioned to support psychedelic-assisted therapy
Winlo continued: “To date, we have cared for over 4,000 patients with major unmet needs (including more than 80 patients suffering with treatment-resistant PTSD) and collected high-quality Real-World Evidence.
“Emyria’s clinical advisory, site network and data infrastructure is uniquely positioned to support safe and scalable psychedelic-assisted therapy, much like we have demonstrated and accomplished with cannabinoid medicines.
“Our goal is to build a unique clinical database that we hope can help optimise the development of existing and novel treatments while also allowing Emyria and our partner, Mind Medicine Australia to become the trusted and accredited clinical service of choice.”
In recognition of the promise of this new field but also the great need for more clinical evidence, on March 17, 2021, Federal Health Minister Greg Hunt announced $15 million in new funding for “Australian medical research projects that use clinical trials to assess the safety and efficacy of innovative therapies using hallucinogens and stimulant drugs supported by psychological/ psychiatric care for treatment-resistant mental illness, compared to standard therapies”.
The past Chair of the Australian Defence Force (1998-2002) Admiral Chris Barrie also recently encouraged the Australian Government to consider the clinical use of specific psychedelics to help veterans recovering from trauma.
Consistent with Federal Government grant
Mind Medicine Australia chairman Peter Hunt AM said: “We are delighted to be working with Emyria on developing the pathway for the use of evidence-based psychedelic-assisted therapies for the treatment of key mental illnesses in Australia.
“MDMA assisted psychotherapy is showing very high remission rates in overseas trials and has also been shown to have high levels of safety and to be non-addictive when used in medically controlled environments.
“Negative side effects have also been minimal.
“The trial approach being taken by Emyria is also consistent with the Federal Government’s recently announced grant of $15 million for trials utilising hallucinogens or stimulant drugs supported by psychotherapy for treatment-resistant mental illnesses.”