Daniel Carcillo is founder and Chief Executive Officer of Wesana Health, a biotechnology company focused on developing the novel therapies of tomorrow and delivering new care paradigms today. A well-known speaker and advocate on behalf of Traumatic Brain Injury (TBI) survivors and people dealing with mental health challenges, Mr. Carcillo spent nearly a decade researching different treatment regimens and consulting experts to find effective care for his mental health conditions. In 2019, Mr. Carcillo founded Wesana, bringing together leaders in the biotech and pharmaceutical industries to move forward his vision to deliver novel pharmaceuticals that help optimize treatment outcomes for patients with mental health disorders.
Prior to that, Mr. Carcillo played in the NHL for nine years and won the Stanley Cup two times.
How did your own experiences, seeking treatment for Traumatic Brain Injuries (TBI) and Post-Concussion Syndrome, influence your founding of Wesana Health?
I fought 164 times in the NHL and had seven diagnosed concussions. After tens of thousands of sub concussive hits, I started experiencing some pretty bad symptoms around age 27. The trauma worsened with time and in 2015 when I was 30, I just couldn't do my job anymore and was forced into retirement. As pro athletes, I don't think you really notice the underlying issues until you transition into the real world, because what we do isn't really “real” in the sense that we're not treated like everybody else. It’s not until you leave the athletic world that you really start to see how sick you are. I was dealing with slurred speech, headaches, head pressure, insomnia, impulse control issues, light sensitivity, memory issues and loss of appetite, on top of anxiety, depression, and suicidal ideation.
I had to start researching what happened to me and how I could fix it. I went to the best neurologists, and concussion pathologists, psychiatrists and psychologists, to help me try to manage my symptoms.
I've always been a mental health and concussion advocate and after experiencing recovery with high and low doses of psilocybin, I felt strongly that this could be the first FDA approved pharmaceutical for TBI related symptoms like depression.
So, I researched how to start a drug development company, reached out to Rick Doblin, started getting integrated into the community, used my own personal money to fund our IP and began to build a championship team to help me execute the vision. Now here we are, a year and a half later as a publicly traded company. We just had a successful pre-IND meeting with the FDA on March 11th and are pursuing clinical trials and IND clearance in Q4 of 2022. We have an operating mental health clinical network in Illinois and are well on our way to helping millions of people who are suffering with mental health complications.
How did you first learn about Psychedelics as a medical treatment?
I realized that nothing was getting better after 5 years of participating in medically accepted treatments to recover my brain health and quality of life. I was constantly testing my brain and my blood to see if I was improving with different regimens. I found myself in a place three years ago where I was hopeless, and suicidal. And then, luckily, I found psilocybin, or rather, it found me through an invitation from a former teammate in my darkest time. Within six months of doing high and low doses of psilocybin in combination with CBD, the retest on my brain came back with no abnormalities and my blood work came back clear.
The number one cause of death after a traumatic brain injury is suicide, and I believe it's because many people don’t understand the symptomology that's derived from the physical impacts. From experience, I know that antidepressants, although they can work for some people, don’t work for everyone. They didn't work for me and they exacerbated a lot of other symptoms. It doesn't make sense to take something that increases suicidal ideation when you're already at risk for it, after a traumatic brain injury. I’m just really grateful to have found this therapy and I feel passionately that it can help other survivors.
Have you tried psychedelics as a treatment option? How did it help you?
I have been to the high jungle of Peru and participated in an Ayahuasca ceremony. I have tried MDMA, ketamine and 5-MeO-DMT, but it is psilocybin that I have used intentionally for three years and everything tied to my health continues to improve. I don't suffer from any of my symptoms anymore. I do not have anxiety; I do not have depression; I do not have suicidal tendencies or thoughts anymore. My light sensitivity is gone. No more slurred speech; no more insomnia. Quite literally, I'm cured. And not only cured, I feel like the highest operating version of myself and I was a pro athlete for 12 years. I just keep getting better and it's really quite amazing. I know that I was a really bad case, suffering from early onset dementia. So, if it can do this for me, what can it do for others?
What is Wesana Health focused on?
Wesana is focused on our drug development pathway for SANA-013. Our novel and proprietary depression treatment protocol includes a single high dose of psilocybin followed by a maintenance regimen of a microdose of psilocybin combined with cannabidiol (CBD) to address Major Depressive Disorder (MDD). In a validated preclinical animal model of depression, the low dose psilocybin maintenance regimen demonstrated up to 64% further improvement in depressive behavior than those observed with a single high dose of psilocybin alone.
Off of the heels of our positive feedback from our March 11th pre-IND meeting with the FDA, we're on a very clear and defined development path that's been accelerated. We are the only company in the space that has defined feedback from the FDA and a path forward for a self administered, non-hallucinogenic at home dose of psilocybin. We also have a term sheet negotiation with MAPS, where we're looking to use MDMA for TBI related symptoms. Those are ongoing negotiations, but that is the care development side or drug development side of our business.
Along the way, there needs to be a framework put into place to be able to deliver these medicines like MDMA and psilocybin, in conjunction with psychotherapy. Wesana acquired a clinical network of mental health clinics with psychiatrist oversight and insurance reimbursable services that will integrate into big healthcare. We believe that everyone should have access to quality, research-backed, affordable mental health care. Our clinics offer a best in-class patient experience that are psychiatric, and psychotherapy led. Our objective is to be at the forefront of innovative mental health care treatments to address the growing need for effective and personalized care.
Can you talk a little bit about your recent Pre-IND meeting with the FDA about SANA-013 and what it is?
Wesana’s SANA-013 is a novel and proprietary depression treatment protocol that includes a single high dose of psilocybin followed by a maintenance regimen of a microdose of psilocybin combined with cannabidiol (CBD). The low, non-hallucinogenic dose of psilocybin in combination with CBD aims to live on a patient's counter to be self administered on a daily basis.
Consistent with the positive feedback received from the FDA, Wesana is also exploring the opportunity to accelerate the development of SANA-013 by initiating a Phase 1b/2a human study for MDD in H1 2023. In contrast to the current development pathway for SANA-013 with TBI associated depression as the lead indication, currently targeting the launch of a Phase 1 study in Q4 of 2022 in a healthy human patient population, the revised development pathway would allow the Company to bypass the healthy patient population study and research an MDD affected patient population directly as part of a Phase 1b/2a study.
It's really exciting news. From the response that we got, we realize that there's really not that many companies out there that have communicated this data in a meaningful way to the FDA. So, I’m grateful for our incredible team, and grateful for the response that we received and for the defined regulatory feedback and pathway to approval that is ahead of us.
What have the Wesana Health Clinics accomplished so far?
Medical billings from Wesana Clinics increased 30% in the first quarter of 2022 as compared to the fourth quarter of 2021. In that same period, overall patient volume increased, led by 95% increase in Spravato appointments.
We are also thrilled to announce the official May 2022 opening of our third facility in Naperville, Illinois. Naperville’s convenient location will complement the existing Wesana Clinics locations in Oak Brook and Chicago, enabling the Clinics to provide high caliber mental healthcare to the growing number of residents in the western suburbs and greater Chicagoland area.
The new 3,000 square-foot facility – located in southwest Naperville – will be overseen by Dr. Abid Nazeer, Naperville native and Wesana’s Chief Medical Officer. The psychiatrist-led clinic will focus on serving the community through the delivery of personalized innovative psychiatric care, inclusive of ketamine therapy, medication management, psychotherapy, cognitive testing, and pharmacogenetic testing. It will also be the first of the Wesana Clinics to offer Deep Transcranial Magnetic Stimulation, which has shown efficacy as a treatment for conditions such as Major Depression, OCD, anxious depression, and more.
Can you talk about using deep transcranial magnetic stimulation?
Deep transcranial magnetic stimulation is an FDA approved medical device and noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. TMS was first approved by the FDA in 2008 for treatment resistant depression.
These electrical currents activate cells within the brain which are thought to release neurotransmitters like serotonin, norepinephrine, and dopamine. Since depression is thought to be the result of an imbalance of these chemicals in the brain, TMS can restore that balance and relieve depression.
What do you believe is the most important thing for people to understand about the future of psychedelics as medicine?
I believe, through rigorous scientific validation via the proper regulatory pathways like the FDA, the development of these molecules will become the new standard of care for mental health treatment.
These molecules, when used correctly, seem to have the ability to address the underlying pathology of why we suffer and help alleviate symptomology with less risk for abuse liability and side effects.
What are you most excited about in the coming year for Wesana Health?
Pursuing IND (Investigational New Drug) approval through the FDA is our next major milestone. Our IND enabling pharmacology and toxicology studies, which have been accepted by the FDA, are underway and ongoing to enable IND approval for Major Depressive Disorder. We're working on some mechanisms of action studies, aiming to produce novel and interesting animal data outside of the IND enabling studies.
We have a very exciting year ahead of us.