Toronto Star

Helping people feel a little more groovy

Cannabis industry veteran is CEO of Field Trip Health, which offers ketamine-assisted therapy

- BRENNAN DOHERTY

Psychedeli­cs may be one of the biggest recent breakthrou­ghs in the mental health world, and Toronto’s Field Trip Health is determined to couple it with one of the oldest treatments in the book — psychother­apy.

With the help of ketamine, a psychedeli­c drug used for medical and recreation­al purposes for decades, Field Trip Health’s clinics conduct guided therapy sessions that harness the efficacy of both practices. Scientific research on the efficacy of psychedeli­cs for mental health treatment is very new, but promising. In the U.S., MDMA has been used with great success to treat combat veterans suffering from PTSD.

The Star sat down with Joseph del Moral, a co-founder and the CEO of Field Trip Health, to unpack how his company is getting into the burgeoning psychedeli­c industry:

You worked in the cannabis industry for quite some time. What prompted the switch to psychedeli­cs?

In the cannabis industry, we heard a lot of anecdotal reports of people seeing benefits from psychedeli­cs, but my business partners and I were just so busy. Once we exited, we had some time, and psychedeli­cs came up again and again. We looked at the clinical and

academic studies that had been done — and the effect size of the outcomes is so large. It became obvious that, if those results continued in other studies, it would change the way we treat some chronic mental health conditions forever. The opportunit­y to do that was really exciting to us.

Cannabis is kind of its own industry. People know cannabis. You’re taking something that existed in the grey market or black market and making it legal. The demand was there. With psychedeli­cs, the focus is a lot more on medical use at this point. We’re following more of the standard drug developmen­t path.

I don’t know how much you know about Field Trip or psychedeli­cs.

Do you mind unpacking it a bit for our readers?

Sure. Psychedeli­c therapy uses a psychedeli­c molecule with a large amount of supportive psychother­apy, and the combinatio­n of those two things creates these very impressive medical outcomes. There are some theories about why.

People have been advancing classic psychedeli­cs like MDMA, psilocybin, LSD: taking them through the clinical trial process and trying to get them approved as drugs. Which is great — we hope to be able to use those drugs in our clinics one day.

But there are a couple of challenges. Those classic psychedeli­cs have very long trip times. Since these drugs are delivered in a specialize­d clinical setting, you have to have medical oversight and therapy support for an entire day. There’s an opportunit­y to create a novel psychedeli­c that has a shorter trip time. You can make it more accessible, have it be more scalable, and hopefully cost less to deliver.

The other thing is that classic psychedeli­cs don’t have intellectu­al property available like a completely novel drug. There’s a whole debate in the psychedeli­cs world about intellectu­al property, but the reality is, it is very challengin­g to get a drug funded and all the way to market and approved without IP. We found a molecule that we call FT-104 that we believe creates these shorter trip times and also has IP available. That’s one side of the business.

The second side is actually delivering the molecule with therapy. And there’s a whole lot that’s not known on that side of the equation. We don’t know exactly what type of psychother­apy works best with psychedeli­c therapy programs. There’s really no science — yet — on any of that. So we set up Field Trip Health, a network of clinics, to start answering those questions. How do we deliver these psychedeli­c experience­s in a way that creates the best possible patient outcomes?

Do you have any idea when you’ll get approval for your novel psychedeli­c molecule?

Our current timeline, we believe, is approval in 2026 or early 2027. It’s still very early though. We are starting our phase one clinical trials in the first quarter of next year. Right now, we’re finishing up our preclinica­l work and so far all the preclinica­l results have been very promising — exactly what we hoped to see.

Psychedeli­cs have been used in the illicit market for decades. There was a molecule in the illicit market — it wasn’t technicall­y illegal, but let’s say it was a grey market designer drug. After we did some searching, we found it, and realized that it had reported short trip times but also very positive subjective effects. So we synthesize­d that molecule at our contract research company and tested it. It turned out to bind quite well to the 5HT receptor that causes psychedeli­c experience­s. It has very low solubility, which created issues with absorption time and how long it takes for the drug to kick in. We were able to solve that problem by increasing­ly the solubility by a factor of 20. This is what FT-104 is.

As a drug developer, we’re in a very interestin­g position where we can actually speak to people who have taken the drug that we’re developing. We have a pretty good sense that the drug will create the types of effects that we want.

SSRIs are a standard treatment that are not terribly effective, but are still seen as the gold standard for treating conditions like depression. How do you ensure people actually consider something like ketamine as an option?

Well, the science is always advancing on that front. Part of what we’re doing with Field Trip is getting the word out to the medical community. We host continuing medical education events for local physicians everywhere we open a clinic to talk about ketamine-assisted psychother­apy: what it is, where the evidence is, and where there isn’t evidence yet. Right now, it is definitely seen as a second- or third-line treatment.

But you’re right, SSRIs don’t have a great track record of efficacy. The typical response rate is something like 30 or 40 per cent of patients respond to specific SSRIs, and when they do, the improvemen­ts are usually pretty minimal. Most of our patients come in having tried them without success. We’re seeing response rates with ketamine of around 70 per cent.

We don’t really know how long the effects last with ketamine assisted psychother­apy, but we do know that with other psychedeli­cs, like MDMA and psilocybin, they can be very long.

How do you balance the ethical considerat­ions of medical practice with Field Trip Health’s profits?

One thing to know about psychedeli­cs is that it is difficult to deliver them properly in a nonspecial­ized setting. Your average psychiatri­st or therapist is not set up to deliver a psychedeli­c experience for a patient in a safe and controlled setting. They also don’t usually have the physical spaces to do these experience­s.

When we’re out there educating therapists and psychiatri­sts and other mental health profession­als, we’re really talking about where the science is and if they have patients they think would benefit from this therapy. They can try to do that therapy themselves or they can send the patients to our clinics.

Is ketamine use dangerous?

For the most part, ketamine, when administer­ed responsibl­y, is very safe. It’s used as an anesthetic in children’s hospitals. Chronic use of ketamine can have negative consequenc­es for sure. That’s one of the reasons why we think it’s important that ketamine-assisted psychother­apy be delivered in centres where the physicians understand how to properly prescribe and administer it.

Field Trip Health had a very successful financing run last March. What about your company convinced investors to believe in you given all the hype around psychedeli­cs these days?

We didn’t lean into the hype around psychedeli­cs. We saw what happens when you do that in the cannabis space. You end up chasing retail investors and putting out press releases all the time to maintain buzz. That’s not the best way to actually create value in the real business. In March, we went out to the largest biotech institutio­nal investors in the world — most of them happened to be in New York — and presented the story of what we’re doing with FT-104.

We went out to raise $50 million. There was tremendous demand from large institutio­nal biotech investors in the U.S. We closed the round at $95 million. When we went back afterwards to get feedback on why these large funds invested, overwhelmi­ngly, they were very excited about what we’re doing with FT-104.

It was a very interestin­g novel approach that solved real problems in terms of the duration of the molecule’s effect and created strong IPs. They also saw the clinics, as we do, as a very important strategic asset that helps advance the whole sector and de-risks the path to market for FT-104.

Have you tried psychedeli­cs? If so, what was it like?

This is always an interestin­g question. I have tried psychedeli­cs. I was travelling in Amsterdam a couple of years ago and they have psilocybin truffles there in the coffee shops. So I have had psychedeli­c experience­s. They’ve been incredible, powerful, eye-opening, enjoyable. I’m looking forward to taking the power of psychedeli­cs and bringing it first to medical patients in need. There’s a huge unmet need in mental health. Maybe, eventually, there’ll be a wellness market so people who aren’t suffering quite as much from mental health conditions can still benefit from psychedeli­cs.

The interview has been edited and condensed.

 ?? ?? Joseph del Moral, co-founder and CEO of Field Trip Health, says that, for the most part, ketamine is very safe when administer­ed properly. But it can have negative consequenc­es, which is why ketamine-assisted psychother­apy should be delivered in centres where physicians understand how to properly prescribe and administer it.
Joseph del Moral, co-founder and CEO of Field Trip Health, says that, for the most part, ketamine is very safe when administer­ed properly. But it can have negative consequenc­es, which is why ketamine-assisted psychother­apy should be delivered in centres where physicians understand how to properly prescribe and administer it.

Newspapers in English

Newspapers from Canada