Psychedelics With Purpose
Interview by Rhiana Dabboussy in partnership with Purpose.
Purpose 2022 was an event like no other, bringing together visionaries across all facets of purpose-driven business. Though Purpose has come and gone, its impact lives on through the businesses, start-ups and leaders who took part in its two-day conference.
One such example is Psylo. A biotech company at the helm of psychedelic-inspired medicine, Psylo develops next generation therapeutics inspired by psychedelic compounds existing in nature. Based out of the University of New South Wales, impact is in Psylo’s DNA – its goal being to produce mental health medications that are accessible to a border patient population.
We sat down with co-founders Josh Ismin, CEO, and Dr Sam Banister, Chief Scientific Officer, to chat all things Psylo.
The concept of psychedelic-inspired therapeutics is absolutely fascinating to me, as I’m sure it is to many others. Are you able to tell me how you got into this space?
Sam: I've always had an interest in psychedelics since I was a younger person, and this was from reading philosophy. A lot of people like Aldous Huxley had written on these topics, and I began thinking about consciousness as a scientific question. I became curious about the underlying science of the compounds in drugs – for example LSD – where you can take a quantity smaller than a grain of sand and it can fundamentally change your entire perception of reality.
There was some emerging evidence historically that psychedelics were useful in the treatment of certain psychiatric illnesses, but prohibition almost shut everything down for a number of decades. So the idea of having a career in this space was not really feasible for me. I knew that I wanted to have a career that had some kind of impact so I moved into traditional drug development.
I had a pretty interesting career in drug development generally. I worked on diseases like ALS, some cancers, diseases of the brain, and gained a lot of background in psychiatric illnesses and neurology. At the time that I was thinking about a career in this space, there were only about two or three academic labs in the entire world doing the sort of work that I wanted to do. I lived in the US for a while and got involved in a startup scene with a few biotechs. When I came back to Australia, I was in an academic role for a few years running a lab doing drug development. Then I met Josh. By then, the timing was just right for a company like this. I'd lost a friend to suicide earlier that year – last year – and was watching the clinical trial space with psilocybin and it was looking promising. It just seemed the perfect time to do something really useful in this area.
Josh: I come from a platform tech background. I used to work at Microsoft and was fortunate enough to build a company that I exited several years ago. I was put into the position to be able to explore a number of different areas to figure out what to do next. I started doing some investments in the alt-protein space. I was an angel investor in Fable (who was on our panel at Purpose) as well as a bunch of other companies that are trying to move the world away from eating meat.
I started to notice that a number of investors were backing these early psychedelic companies that were taking natural products to clinical trials. It seemed like an amazing focus area for the next stage of my career. My wife runs a research commercialisation centre at Sydney University and that's how I connected to Sam. It’s a great partnership. We complement each other in a number of ways which has meant that we've been able to get a lot done really quickly. There’s a lot ahead of us as well – it's really exciting times.
You mentioned prohibition and that a career in this space wasn't viable for quite some time. What is Psylo’s strategy in marketing psychedelic inspired drugs to the wider public who might be put off by the idea behind them?
One of the problems that we're trying to solve is that psychedelic assisted psychotherapy will not be suitable for everyone. There are very good reasons why people should not take psychedelics, for example people with a familial history of schizophrenia. So one of the classes of compounds that we're particularly interested in developing is a sort of ‘rapid acting antidepressant’ where you can remove the hallucinogenic properties of the drug, but retain therapeutic benefit.
The way we think about it, the early movers in this space who are taking natural compounds, like psilocybin through clinical trials, are paving the way for psychedelic assisted therapy as a modality. There are various other modalities that are still in early stages of exploration, which we're watching with interest. The way we think of it is not ‘psychedelic or not’, it's really compounds that are capable of eliciting neuroplasticity and have tempered effects to the first generation compounds. Psychedelic assisted therapy will not be for everyone. Would your grandma go to a location to take a six to eight hour psychedelic, immersive experience alongside clinicians?
What has been the response of the medical profession?
Certain bodies like the medical colleges are obviously pretty conservative. But when you get speaking to psychiatrists and other groups, they're actually quite open to the idea. The medical toolbox for psychiatry has had the same tools for so long and they don't really work that well. They're pretty excited for the opportunity to use new approved medicines that have a much different mechanism of action. A lot of psychiatrists are being swayed by the evidence. As more and more trials are conducted, they're looking at increasing numbers of indications. They're looking at increasingly larger patient populations. And they're seeing some phenomenal results. I think a lot of doctors are being swayed by the data. It’s impossible to ignore.
There is no take up yet because this is not yet legal. But the landscape is shifting rapidly. COMPASS Pathways announced their phase three clinical trials for their crystalline formulation of psilocybin recently which has been greenlit by the FDA. Barring any surprises, psilocybin is set to be available by prescription within the next several years. So I think you're going to see a lot of change in terms of people's perception of the efficacy and the viability here. Once you see the regulator actually give the thumbs up that a drug is an approved medicine and is available by prescription, the DEA will then be forced to reschedule psilocybin from a schedule one drug. I think over the next several years you're going to start to see more widespread acceptance.
What specific kinds of health issues or conditions will you be targeting or addressing with your therapeutics?
We're still considering which diseases will make the most sense for the pipeline of medicines that we're developing. But if you look at the trials with psilocybin and related psychedelics currently occurring, everything from end of life anxiety associated with a terminal diagnosis, to anorexia nervosa and other eating disorders – these are very hard to treat conditions that don't have effective treatments at the moment. Various drug use disorders. There's a whole host of them.
All of the trials that are happening with psilocybin are really guiding us and informing us on where the efficacy lies and where there are potential solutions that we can focus on in the future.
How do you go about targeting a condition as complex as anorexia with a drug?
One of the common themes with many of the conditions that are being explored is that they have some underlying psychological component. They are not purely biological diseases.
One of the ‘modes’ by which classical psychedelics seem to be working is that they allow a person to have this relatively intense experience. It's often described as providing a lot of insights. Often those are quite objective insights into a person's situation. It's that experience in conjunction with psychotherapy that amplifies the power of the psychotherapy itself.
It's quite feasible that for a condition that's predominantly obsessive in nature – meaning that it arises in patterns of unhelpful, repeated thought – that through intense psychedelic experience and therapy that behaviours could be changed in a very profound way.
Do you foresee treatment being a one-off that cures a person’s condition? Or would it be ongoing to manage symptoms for a person’s foreseeable future or potentially the rest of their life?
Both are possible.
For psychedelic assisted therapy, acute dosing is really for someone experiencing a pronounced symptom that needs to be addressed through a macro dose of a psychedelic. They would experience a psychedelic trip fully immersive alongside a clinician with sessions before and integration sessions after.
There are other clinical trials that are happening right now exploring micro dosing of psychedelics simply for ongoing wellbeing. That is something we are interested in.
So far, the data looks really promising that psychedelic assisted therapy helps people break these cycles of negative thought and shifts their lives in a better direction. One of the things we know from the current studies is that the effects are pretty rapid. After these treatment sessions, you see effects within 24 hours. In a substantial minority of treated patients – about one third of the patients in the phase two study for depression – those effects are maintained even 12 weeks after that single dosing session.
Are there any side effects?
Psychedelics are non toxic substances, and they don't really seem to have any serious sort of physiological side effects as used in the current psychotherapy model. The biggest risks with psychedelic assisted therapy are in susceptible patient populations who might be at risk of schizophrenia or psychosis – that there is always the possibility of triggering some underlying latent condition. But so far, at least in the patient populations that have been explored, that has really not come up.
First generation psychedelics do interact with a serotonin receptor that carries a heart risk, which could be an issue when administered repeatedly. That’s one of the development liabilities we’ve taken into account in optimising our pipeline of novel compounds.
Joshua Ismin is CEO/co-founder of Psylo with diverse commercial and operational experience. He holds an MBA and BSBA from Washington University in St Louis. Josh is a repeat founder with extensive fundraising and operational experience across a number of tech start-ups, including an exit - and is an active biotech investor.
Dr Samuel Banister is CSO/co-founder of Psylo with extensive small molecule drug development experience in academia and the private sector. He completed his postdoctoral training at Stanford University, developing new clinical candidates for treating neurodegenerative diseases like ALS and leading to the formation of Tranquis Therapeutics. In addition to consulting for a number of biotech startups, Sam spent several years as Team Leader in Medicinal Chemistry with The Brain and Mind Centre at The University of Sydney.