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Industry Interview Series - Dr Michael Winlo

03/03/22 - Meet Dr Michael Winlo, Chief Executive Officer and Managing Director of biopharmaceutical company Emyria. Emyria, which listed on the ASX last year, has seven patient-treating clinics around Australia, which it uses to progress the development and registration of new drugs. We chatted to Michael to find out more about Emryia's recent MDMA-assisted therapy trials, their approach to COVID, and what's next on their 'to do' list.

To begin with, can you tell us a bit more about Emyria and what makes your business unique?

In short, Emyria develops biopharmaceuticals. What makes us different is that our clinical development programs are guided by robust and ethically-sourced clinical data that we collect with patients who are also receiving care from our clinical service subsidiary, Emerald Clinics. Our belief is that we can accelerate the end-to-end drug development and registration process by (1) helping facilitate access to new treatments for patients who are not responding to their current treatments and, (2) doing a great job learning from the experience of every patient. Major regulators around the world are starting to acknowledge that the usual way in which new treatments are evaluated - randomised clinical trials - can sometimes like generalisability. Often, patients on trials do not look like the patients sitting in front of most doctors and therefore, great results seen in a clinical trial might not translate to other patients. In response, major regulators, in particular the FDA in the US, are putting greater value on “Real World Evidence”, that is, clinical evidence generated from data gathered in routine clinical practice. This is why we are investing in clinical data capture and closely tracking outcomes data for each of our patients. We believe the RWE that we are able to generate allows us to re-risk our clinical development programs and shorten the time to registration. Which, is win-win for patients and investors. We have launched two broad clinical development programs to date. One in cannabinoid medicines - which are still hampered by a lack of high quality clinical evidence. Our second stream is working with MDMA-like compounds which are seeing renewed interest when given alongside psychotherapy.

Tattarang recently made a $5m investment into your $EMD, a great endorsement for the work you are doing. What impact does that level of investment have on the business and what it can achieve?

We’re delighted to have the support of Tattarang. The funds obviously allow us to make great strides towards our drug registration goals but the endorsement signals to other investors is equally important. Tattarang’s support is a sign our approach is credible and worth supporting.

Emyria has recently been in the news for your MDMA-assisted therapy trials? Can you tell us a bit more about those?

Yes! MDMA (also known as the recreational drug "ecstasy”) has recently been demonstrated in some very high-quality clinical trials, including a randomised controlled Phase 3 trial, to be a very effective treatment for post-traumatic stress disorder (PTSD) when given alongside supportive psychotherapy. The combination of MDMA plus therapy was astoundingly effective, with ~67% of participants on active treatment entering a full remission from their PTSD symptoms.

A great challenge with these therapies though is the clinical delivery. You require at least 2 trained therapies at all times during therapy - which can last for up to 12 hours. So, at Emyria, being a specialist practice for patients where current treatments are no longer effective we are eager to understand how these treatments might be implement safely in a clinical service. Further, we are interested in adding to the knowledge of how these treatments work and for who so we have developed a series of clinical trials with our partner Mind Medicine Australia which will allow us to offer MDMA-assisted therapy to a broader patient cohort while also monitoring important biometric changes to assist the therapists.

Our MDMA interests also extends to the development of novel MDMA-like analogues. We recently entered a partnership with the University of Western Australia (UWA) to help screen a library over ~100 MDMA-like compounds. Given the legal status of MDMA, research on this compound has been slow going. However, the team at UWA, led by Prof. Matt Piggott, has developed an incredible asset of compounds over 10 years. For a number of reasons, we are optimistic that there may be next-generation psychedelic-assistted therapies and potential treatments in that library.

Emyria has 7 front line treating clinics around Australia and opened a second clinic in Perth last year. What makes Perth such an attractive city to host clinical trials?

Our recent growth in Perth probably has more to do with the pandemic and, until recently, our relative isolation from it’s consequences. However, I will say that Perth is an exceptional place to run trials. We have very deep trials talent here, an excellent Phase 1 clinical trial service - running both healthy volunteer trials and early phase cancer trials - and clinicians are quite collaborative which is an advantage when it comes to study design input and patient recruitment.

WA is about to undergo a big change in our approach to COVID when the borders open up on the 3rd of March. How do you envisage that impacting your business here in Perth?

With an International distributed Board and global drug development plans we’ve continued to do business “globally” however, we can’t wait for the boarders to open and start to meet our supporters and partners in person. If you want to be a global company from Perth you have to be prepared to travel.

What’s next on the ‘to do’ list for Emyira? Anything you can share with us about plans for expansion, new trials or new team members?”

We have significant plans for 2022 and beyond. We are progressing our first cannabinoid biopharmaceutical towards registration. Pivotal clinical trials will start soon. We expect our cannabinoid medicine portfolio to expand too so we leverage our Real-World Evidence and pursue additional indications.

MDMA analogue program will enter animal studies and help us identify a number of leading compounds from our library. On the research front, we will commence our MDMA-assisted therapy trials and publish some deep research we are completing on our registry data. And last but not least, we will continue to treat thousands of patients with new treatments for a range of conditions, simultaneously providing personalised care and adding to our knowledge of what’s working best for whom. That is, after all, our greatest goal - to learn from every patient to ensure their experience can help others like them.



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