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Content warning: this article includes a discussion of suicide
Nick Watchorn was a first responder at the Port Arthur Mass Shooting in Tasmania. He worked the scene of the crime for days after, and was left with images that will never leave him.
Shortly after, Nick left the Tasmanian police force and was diagnosed with Post-Traumatic Stress Disorder (PTSD).
For 20 years, Nick tried all kinds of treatment. From psychotherapy to pharmaceuticals, nothing worked.
And sadly, Nick is not alone. When it comes to PTSD, there are not a lot of great treatment options. Experts suggest that even the most effective treatment options are only effective about 50% of the time.
That was when he was introduced to MDMA Therapy. Also known as ecstasy or molly, MDMA is better known as a party drug. But a growing body of research suggests that MDMA may have therapeutic applications including helping people suffering from PTSD.
Nick, now living in the United States, took part in a FDA-approved, Phase 3 study on the effectiveness of MDMA therapy. He believes this MDMA therapy “cured” his PTSD.
PTSD in Australia
Here is a startling statistic: over 1 million Australians are affected by Post-Traumatic Stress Disorder (PTSD).
According to Beyond Blue, around 12% of Australians experience PTSD in their lifetime and around 6% of Australians experience it in any 12 month period.
¹ All medicines carry risks and specialist prescribers, such as registered psychiatrists, are best placed to assess the suitability of a new medication against a patient’s individual circumstances and medical history before proceeding. Adverse effects of MDMA include high blood pressure, increased pulse rate, faintness, and panic attacks, and in some rare cases it can cause loss of consciousness or trigger seizures. Other side effects include involuntary jaw clenching, decreased appetite, restless legs, nausea, headache, sweating and muscle/joint stiffness. These effects are unlikely at low doses in the treatment regimens used in psychedelic-assisted psychotherapy while appropriately managed in a controlled environment with direct medical supervision.
Around the world, it is estimated that 350 million people suffer from PTSD.
It is common and there are not a lot of great treatment options.
Source: Emyria Company Presentation
Introducing Emyria
Emyria is the only ASX-listed company developing psychedelic-assisted therapies, a body of treatments that include MDMA therapy.
Emyria’s mission is to develop, and deliver, innovative new treatments for mental health. Its leading program is a unique care model of MDMA-assisted therapy for Australians suffering from PTSD.
The company was founded in late 2018 and two years later, in 2020, it listed on the Australian stock market (ASX ticker: EMD).
Since that time, the company has been working on developing a unique set of capabilities for developing and delivering therapies for unmet medical needs. The company’s first area of interest was to improve access and improve the formulations of newly rescheduled compounds like cannabidiol (CBD). Using data from its clinics, the company developed an ultra-pure cannabidiol (CBD) capsule for the treatment of anxiety and pain. In 2022 that drug product was accepted into a fully funded initiative run by the US National Institute of Health’s Preclinical Screening Platform for Pain.
Now, after providing care for more than 20,000 patients, the Company is expanding its offerings to include psychedelics such as psilocybin and MDMA. At the moment, the company is focussed on evaluating the potential of MDMA-assisted therapy for PTSD.
Source: Emyria Company Presentation
To deliver its treatments, Emyria operates its own clinics under the brand names: Emerald Clinics and the Pax Centre.
- Emerald Clinics – 3 locations – specialises in providing treatments for patients with complex and chronic conditions. They specialise in treatment with unregistered medicines for patients that have exhausted conventional therapies
- The Pax Centre – 1 location – specialises in treating individuals grappling with the psychological impacts of traumatic experiences. Emyria acquired the company in July 2023.
The company has recently achieved all regulatory approvals for its treatments and has been training a multidisciplinary team of specialists and therapists to deliver them. Prior to the Pax Centre acquisition, the company was making between $1-2 million a year in revenue and is not profitable.
Source: TIKR.com
At this stage, it is difficult to assess the economics of these emerging treatments. The financial questions like the size of the market and the profitability of these treatments cannot be answered until the business and regulatory questions are answered and a commercially viable delivery model can be demonstrated. Of note though, is that the scientific questions: namely the safety and efficacy of these treatments, appear to be promising from the two large Phase 3 trials completed to date.
So, for a company like Emyria, the opportunity is to establish a scalable delivery model and engage the major health payers to cover the cost of treatment. If we continue to see a growing body of evidence that psychedelic-assisted therapies have benefits, then Emyria wants to be positioned to capitalise on the increased social and medical acceptance that will inevitably follow.
The science
Returning to Nick Watchorn, the Phase 3 study he participated in was conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS).
The conclusion of that study was published in the journal Nature: MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. The study concluded:
These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation.
On the MAPS website, they summarised some of the findings from their first of two Phase 3 trials.
In our first Phase 3 study, 88% of participants with severe PTSD experienced a clinically significant reduction in PTSD diagnostic scores two months after their third session of MDMA-assisted therapy, compared to 60% of placebo participants.
Additionally, 67% of participants in the MDMA group compared to 32% of participants in the placebo group no longer met the criteria for PTSD two months after the sessions.
The publishing of this study, and a number like it around the world, has seen governments start to act on these results. On 1 July 2023, Australia recognised the therapeutic potential of psychedelic-assisted therapies and rescheduled them as controlled medicines. This made Australia the first country in the world to reschedule MDMA and psilocybin and the fourth country (after Israel, the United States and Canada) to allow for some psychedelic assisted therapies in controlled clinical settings.
This world-first move also established a highly stringent framework for the provision of these treatments. A framework that very few clinicians have been able to comply with – with the exception of Emyria.
Source: Multidisciplinary Association for Psychedelic Studies
Elsewhere in Australia, there is ongoing research into the broad potential of psychedelics. In 2020, Monash University established Australia’s first clinical psychedelic lab. Researchers at Monash University have added to the growing body of global research, including a clinical trial on psilocybin-assisted psychotherapy for generalised anxiety disorder and a clinical trial on the safety and efficacy of MDMA-assisted therapy for PTSD in military veterans and first responders.
What next for Emyria?
As research on clinical uses of MDMA continues around the world, Emyria is working to establish itself as a leader in the commercially viable delivery of psychedelic-assisted therapies around Australia. As promising as the science is, it means nothing if these treatments can’t get to patients who might benefit.
The clinical data Emyria collects through their clinics helps improve their care models and helps guide Emyria’s own drug development efforts. In partnership with the University of Western Australia, Emyria is developing one of the world’s largest libraries of MDMA analogues. The company believes these “MDMA-like” drugs have the potential to address a wide range of neuropsychiatric disorders by changing the MDMA molecule in targeted ways in order to amplify certain benefits and improve side effect profiles.
In October 2023, Emyria successfully imported sufficient supply of pharmaceutical-grade MDMA from Canada to support their MDMA-assisted therapy programs. Emyria believes the initial supply of MDMA can support 70 patients.
Then, in January 2024, the company’s lead psychiatrist secured Authorised Prescriber status from Australia’s Therapeutic Goods Administration. This was the important final step to being able to prescribe MDMA under Australia’s new rules for MDMA and psilocybin treatment for PTSD and treatment-resistant depression.
Source: Emyria
As one of the only clinical services in the world capable of providing these treatments, Emyria’s vision is to lead the delivery of these new treatments while also leveraging the knowledge gained to develop the next generation of drugs to help treat our greatest mental health challenges.
Emyria believes the business they’ve built is difficult to replicate. They are the only ASX-listed company to establish a profitable clinical centre focused on innovative treatments like psychedelic-assisted therapies, and they believe this headstart and the data they collect from their clinics and from their trials will help build a pipeline of new innovation. The company hopes that this will be able to deliver the dual-benefit of improved patient outcomes and long-term value creation for their shareholders. It will be an interesting journey to watch.