We’re addressing unmet needs in chronic pain and other indications.

At this point, I spend much of my time studying chronic pain and the intersection of chronic pain with cannabis, and more recently psychedelics, as well as other pain management strategies.

I first encountered the folks from Tryp about a year ago when they reached out to the anesthesiology department at the University of Michigan about potentially working together on a clinical trial for psilocybin-assisted therapy for patients with fibromyalgia. And you know, this was an exciting, but also somewhat intimidating sort of proposition, the use of a Schedule I drug, which comes with all kinds of challenges associated with it on the bureaucratic side of things. But after a lot of thoughtful conversations and, frankly, a little bit of hand wringing departmentally—and also just realizing that we were coming up with a study that we thought was very impactful from the scientific side of things as well as clinically—we decided to join forces in this partnership to do a clinical trial with psilocybin-assisted therapy for fibromyalgia. I am the Principal Investigator for that study and am helping to lead it.

Right now, in the psychedelic side of things, and the psilocybin side of things, I'm mostly focused on chronic pain and fibromyalgia. In other spaces, especially related to cannabis, I'm thinking a lot about different arthritic conditions like knee osteoarthritis, for example. Fibromyalgia is one of those very difficult to manage chronic pain conditions.

There are actually several FDA approved medications. And while these are available to patients, many people don't find them to be especially effective, or if they work for pain, they have negative side effects. And there's quite a bit of consumer dissatisfaction with them. Now, there's a bunch of other types of therapies that people with fibromyalgia can go to, including non-medication therapies like meditation, yoga, physical therapy, and cognitive behavioral therapy. But the issue with a lot of these treatments is that they are very difficult to access in a medical setting, or just generally because of a lack of practitioners. Further complicating matters, there may not be insurance coverage. So for massage, acupuncture, yoga, or meditation it can be difficult to find an insurance company that will pay to cover the cost of that. While we as a field have a decent sense of how best to manage fibromyalgia, it still can be difficult and there are a lot of medical barriers in place. People with this condition tend to often be looking for alternative treatments to best manage their symptoms.

I'd say at this point, it's quite mixed. Some people manage to piece together what I like to call a “toolkit of approaches” that combine some medications, some lifestyle choices, and some work with a medical professional. But many have uncontrolled symptoms that are very difficult and that can prevent people from finding employment, from spending time with their family, and from doing the things that bring them meaning and purpose. I think that the lack of a cohesive treatment plan that is consistently available to people means that there is the need to come up with new and possibly more effective treatments to help manage this condition.

I think that there's a few ways that psilocybin in combination with psychotherapy could be helpful. One is that getting some perspective and understanding of where the individual is that in that specific moment can be incredibly helpful. Much of the time, what happens with chronic pain and fibromyalgia is it becomes something that interferes with and seeps into every aspect of life. This can especially be the case when somebody is chasing after the next, hopefully, useful treatment, or cure, or whatever it might be. Something that I think psilocybin-assisted therapy could do is give people some perspective, give them a little space from that condition, allow them to see where they are, who they are, and then what types of things might actually allow them to enact the type of behavior change that would allow them to start taking some steps in a more productive direction when it comes to their condition. I think there's both the action of the psilocybin itself that is very exciting for that, but then also that support of the therapist to take this potentially mystical experience and help the patient put those pieces back together in a cohesive way so that they can start making those incremental steps again—be it lifestyle or medical treatment to help them on the path to better manage their symptoms.

Obviously, this is a pilot study that we're doing and, to my knowledge, there have not been any studies of psilocybin-assisted therapy for fibromyalgia before now. I want to make sure that people know that we simply don't know the answers to many of our questions about the treatment at this point. However, if we look at studies of other conditions with psilocybin-assisted therapy, say major depressive disorder, or generalized anxiety disorder, the affects of the treatment seem to come on pretty quickly, sometimes within a week or a month. And it's possible that we might see that quick of an onset of effect for people with fibromyalgia as well. I will say, though, that one of the things I'm really excited about is not just that acute effect, but the persistence of the effect. For example, if somebody is able to honestly view themselves and see where they're at and see some of the things that they're doing that might not be helpful for their symptoms, and then they're able to start making changes to push them in a different direction—I imagine those gains accumulating over time instead of plateauing in the way that people often describe with current medications. It's almost like pushing a snowball down a hill, and it gains momentum over time instead of just stopping. That persistence of effect is definitely something that I'm interested in and exciting about, especially given that this is a novel therapy. I expect that, as with all pain medications, there will be some people who do not respond. That's typically what happens with pretty much any medication that is out there. For those who do respond, I imagine that what might happen is a reduction in symptoms. And not just waking up one day and saying my pain is gone, but instead waking up with a renewed sense of purpose, with a renewed understanding and perspective of where they are in that moment, and what they might be able to do in an effective and useful way that day to help manage their symptoms—and to then see how that changes and builds over time.

There's a quote that I often think of that is attributed to Carl Rogers that is, “The curious paradox is that when I accept myself just as I am, then I change.” When you think of it in that sense, then giving that ability to be in the present moment, to accept who you are, and then to build from that place of self-awareness and understanding can catalyze the opportunity for the type of change that a lot of people are hoping for in their life. One of the reasons that I'm so excited about it is because it's not that you just give somebody a magic pill—it’s that they take it on themselves to be able to start making those changes in their own life.

My general area of expertise is pediatric endocrinology, but I specialize in disorders that cause early onset childhood obesity.

I've worked with Tryp Therapeutics for about a year on development of a program to investigate psilocybin plus psychotherapy as a potential treatment option for individuals with these conditions that cause them to not feel full when they eat.

Right now the primary indication that we're pursuing for psilocybin plus psychotherapy is for people with hypothalamic obesity. Hypothalamic obesity is obesity due to something wrong in the area of the brain that controls energy intake and energy expenditure. Individuals with this condition not only become overweight because of this defect, but also are constantly hungry—they never feel full. Hypothalamic obesity can be caused by a genetic defect, or it could be caused by a brain tumor being removed that damages the area of the brain, the hypothalamus, that controls those aspects of life. It is obviously a very devastating condition for these individuals. We're also looking at this treatment option for people with severe binge eating disorder. This is binge eating disorder that is really uncontrollable—eating tens of thousands of calories at a time and not being able to control that.

Unfortunately, right now, for people with hypothalamic obesity there are no treatment options available. People are very desperate, and they're searching out anything and everything they possibly can to try to help these individuals who are affected with this. There are big Facebook groups and internet forums where people are trying to talk to one another and find options that are not FDA approved and off the books to try to help these individuals because it is such a poor quality of life with this condition. It really affects their independence. Right now, there are no available treatments and so, of course, we're very excited for the potential of this treatment for these individuals. For people with binge eating disorder, there are a few drugs that are FDA approved for treatment of binge eating disorder, but that tends to be more mild binge eating disorder. Those drugs tend to not do anything, unfortunately, for people who have really severe binge eating disorder like those we're talking about for this trial.

The range of outcomes can be from very successful and control of the eating and the weight to no efficacy whatsoever. Obviously, that's extremely disappointing for these individuals. Because this is a very life limiting situation for these individuals, then if you cannot control your eating then it's virtually impossible to be completely independent in this world.

The hope is that psilocybin in combination with psychotherapy will actually change their eating behaviors and hopefully make the reward value of foods somewhat less to them—less salience involved with eating, and also potentially to change some of their negative feelings about this behavior. You can imagine that these individuals, when they are hungry, and they steal food, or they sneak food, or they eat from the garbage, they feel really guilty and bad about it. And they don't want to do these behaviors, they're just that hungry. The thought of this drug trial is that potentially it will alter some of their neural connections and their brain network in order to hopefully decrease the appetite drive and also decrease the reward value that food has for these individuals.

Our hope is that the treatment will have an almost immediate effect on the patients. It's a two-dose treatment trial; our hope is that the first dose will have some efficacy, and then the second dose will further improve the efficacy of the medication with psychotherapy. We are hopeful that the treatment effects will last for several months. Of course, we don't know that because we haven't done the trial yet. But our hope is that they would last for several months so that this treatment modality could be used potentially just a few times a year to keep these issues under control for these individuals.

The potential impact on patients’ lives is that it would be life changing. Quite honestly, it would be life changing. These individuals really suffer. It's hard to imagine if you haven't been through this what it is like to feel hungry all the time and to eat and not feel full—to feel driven to steal money to steal food, etc. It's just it's a drive that is all-consuming. To no longer have that drive would be absolutely, stunningly impactful for these individuals and for their families. It would allow them to drive a car, it would allow them to hold down a job. It would allow them to do things like go to college to do things that they have every other potential to do. But the food issues actually make it almost impossible for them to do these things. And so it would really allow them independence, and that would be huge.

We expect to begin enrolling patients in our upcoming eating disorder trial in 4Q 2021 and in our fibromyalgia trial in the first half of 2022.

Until our Principal Investigators begin enrolling patients, you can sign up on the Patients portion of our website at tryptherapeutics.com/patients to be contacted once enrollment begins for the respective studies. Our Phase 2a clinical trials are fairly limited since we are primarily seeking to evaluate the effect size of our treatments for patients rather than optimizing the treatment regimen; our Phase 2a study for eating disorders is expected to enroll a total of 10 patients, and our Phase 2a study for fibromyalgia is expected to enroll 20 patients.

Our Phase 2a study for eating disorders will be conducted at the University of Florida in Gainesville, Florida. Our Phase 2a study for fibromyalgia will be conducted at the University of Michigan in Ann Arbor, Michigan.

Before our proprietary drug product, TRP-8803, can be commercialized, we expect that we will need to complete Phase 2a, Phase 2b, and Phase 3 clinical trials. We would then file a New Drug Application with the FDA to seek approval to market the new product. The review by the FDA often takes at least 12 months. Because of those important and stringent requirements for new drug products, then it will be at least a few years before physicians will be able to prescribe our products to patients.

We expect that the research we are conducting with our upcoming clinical trials will help determine how often patients would need to be treated with our psilocybin-based products. Our Phase 2a studies will evaluate both single-dose and dual-dose treatments, all with accompanying psychotherapy.