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MDMA for Traumatic Brain Injury To Be Studied in $1.5 Million Partnership

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A new partnership between MAPS Public Benefit Corp (PBC) and Wesana Health will see $1.5 million contributed towards investigation into the therapeutic potential of the psychedelic compound MDMA in treating traumatic brain injury (TBI).

TBI affects millions of people worldwide and is
estimated by the Centers for Disease Control and Prevention (CDC) to lead to the deaths of roughly 60,000 people in the United States each year – a third of which are as a result of suicide.

Among the millions affected is Wesana CEO Daniel Carcillo, a former professional ice hockey player who was inspired to move into industry after a life-changing experience with the psychedelic psilocybin. The collaboration with MAPS, which is finalizing
Phase III trial data on the potential of MDMA to treat post-traumatic stress disorder (PTSD), will see Wesana obtain an exclusive license to use MAPS's protocols and MDMA for the treatment of TBI. We spoke with Carcillo and MAPS PBC CEO Amy Emerson to find out more.

Ruairi Mackenzie (RM): How significant is the patient base that could be benefited by MDMA-assisted psychotherapy for TBI?

Daniel Carcillo (DC):
TBI is an interesting indication. I’ve been dealing with it personally for the last seven years as a patient and have identified extremely fragmented areas within psychology and neurology that do not communicate with each other.

We’re addressing things from the beginning, from diagnosis to education awareness – how to recognize signs and symptoms that a car accident has affected your life or that playing football in your youth has really derailed things. Once that's recognized, then you can move into treatment plan.

There are a lot of downstream symptoms. You’re dealing with not only neurological issues, but with physiological issues, and then you're also dealing with mood sensitivity, impulse control issues, insomnia, light sensitivity, noise sensitivity.

We talk a lot about athletes, vets, victims of domestic violence. But your everyday older TBI patient population, injured, for example, in falls, actually dwarfs the athletic community that we're trying to get that education and awareness to. 

It's a tough indication, but there are so many things that can easily be addressed to make this a much better journey for not only the patient but the caregiver. Wesana is just trying to work across that daisy chain and these drug development programs can address some of the symptoms that arise within this journey for both the patient and the caregiver.

Amy Emerson (AE):
It’s hard, because there's a lot of misdiagnoses and a lot of dual diagnosis with PTSD, to get a true handle on how large the TBI population is. I know that there are millions of TBI-related emergency room visits and as Daniel was saying, the wider TBI population outside of sports and vets is much larger than the one that we focus on, and I think that's similar in our PTSD research.

Now that brain science is improving. It's starting to be easier to diagnose TBI. It took a long time to figure out what was going on with people with PTSD and with TBI – there’s a lot of overlap. The two conditions are similar in the way that they have a huge impact not only on the person but the caregiver, the family, the community. People end up with chronic pain, neurological symptoms and suicidality. It’s a large need with not a lot of treatments available for either of these indications.

What MAPS has done really well is build a community that knows exactly where to look to find support and help. With Wesana, we're trying to do something similar – building this community of like-minded people want to live a happy and fulfilling life and regain their quality of life through these holistic measures. It’s not just about developing these pharmaceuticals and that's probably one of the things that I am most excited about.

RM: What's the timeline for the studies that are falling under this new partnership between MAPS and Wesana?

I think right now it's hard to have a specific timeline. This is going to be a period of feasibility assessment to see the details of how we want to work together on this and see what kind of agreement we come to.

That's part of the work that we need to do together – to make a timeline of clinical research like that, there's a lot of complex moving parts, especially when doing something together. We're going to look at joint scientific input into this, regulatory input – going to the Food and Drug Administration (FDA)  is always hard to pin a timeline down with – building a team and building our relationships. That’s what we're going to be figuring out to enable us to come up with a good timeline.

The fact that we're going to have a timeline means that the time to getting this out there is shorter than it would have been. Like Daniel said, we're really focused on MDMA for PTSD, and then we're going to look at other indications, but the fact that we can start thinking about it now is beneficial not only to Wesana but also to us.

RM: What are the proposed mechanisms by which MDMA might assist TBI patients?

The last seven years of my life has been just reading as many Pubmed papers as I could and educating myself on what had happened to me and then how I could fix it and then how to tell other people how they can fix themselves.

As I did that, I came across these compounds that help the brain communicate in areas that were once shut down. It doesn’t just have to be trauma, it can be emotional too, right? We see the same types of things happening in the brain where we just have to awaken these areas. Whether that's through old pathways or new pathways. Breaking down these destructive thought patterns, which a lot of us with TBI are definitely caught in. And then with the right set-setting-dosage creating these new thought patterns, creating these new ideas, creating these holistic ways of operating our life and staying within those.

When I first saw Robin Carhart-Harris’s study in 2014 – that was specific to psilocybin – it was really that moment where I was like, wow, this could help TBI survivors. This could possibly be the first pharmaceutical that could be approved specifically for it. Although I can't tell you right now how this has helped my pathology, we know these medicines do an amazing job – not only for some of the symptoms.

I think when a survivor is embarking on recovery, shifting perspective of their recovery and framing that in a really positive manner is one of the most important things that we can do right away, and that's what a lot of these psychedelics do. That is, to me, what is the most exciting part about what we're talking about right now in the context of a TBI survivor’s journey.

What we see is that there are similarities between what is happening in the brain with TBI and PTSD. All of this is still investigational and unapproved, and we're still figuring it out, but the mechanistic action that we see is this idea that MDMA can reopen the critical periods in the brain, and that is what's associated with the increased plasticity and changes in social reward learning.

We also see improvements in neurological symptoms. We see improvements in pain and then we see improvements in suicidality and all of these pieces are in common, so you also see changes in activity with PTSD - the fight or flight is dampened and the places where your brain processes logic have increased activity, so we know that there are changes happening in the brain with MDMA and PTSD and we think that these same types of changes are going to be helpful for TBI symptoms.

Daniel Carcillo and Amy Emerson were speaking with Ruairi Mackenzie, Senior Science Writer for Technology Networks.

This interview has been edited for length and clarity.