Mydecine to launch Phase 2A clinical trial on psilocybin assisted psychotherapy to treat PTSD in veterans

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June 25, 2021

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Mydecine to launch Phase 2A clinical trial on psilocybin assisted psychotherapy to treat PTSD in veterans
Mydecine is well-funded to advance its IP portfolio and carry out advanced clinical trials with its proprietary psychedelic molecule MYCO – 001

By Uttara Choudhury

Mydecine Innovations Group Inc (NEO:MYCO) (OTCMKTS:MYCOF) (FRA:0NFA) is the first company to treat post-traumatic stress disorder (PTSD) and smoking cessation with the natural form of psilocybin (MYCO – 001).

The Denver, Colorado-based biotech is gearing up to launch a Phase 2A clinical trial on psilocybin-assisted psychotherapy to treat PTSD in veterans. Mydecine hopes to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting.

“We are waiting for final approval on our Investigational New Drug before launching our Phase 2A PTSD clinical study in the late third quarter, or early fourth quarter,” Mydecine co-founder and CEO Joshua Bartch told Proactive in an interview.

Psilocybin is a tryptamine that binds to serotonin receptor 5-HT2A in the brain. At certain doses, the psilocybin elicits profound changes in consciousness and has great potential in treating mental health disorders.  

Mydecine is well-funded to grow its IP portfolio and carry out advanced clinical trials with its proprietary psychedelic molecule MYCO – 001.

Roth Capital recently initiated coverage on Mydecine with a 'Buy' rating and a C$3 price target, citing the “blockbuster potential” of MYCO - 001 for PTSD peaking at “$3 billion five years after introduction (2027).”

Mydecine has identified four patentable lead drug candidates which include MYCO – 001, a pure psilocybin from natural fungal sources; MYCO – 003, a psilocybin-based formula with reduced anxiety potential; and MYCO – 004, a patch delivered tryptamine compound.  

A serial entrepreneur, Bartch co-founded the cannabis wholesale platform which was acquired by Helix TCS.

Proactive sat down with CEO Bartch to learn about Mydecine’s clinical calendar and how it is leading the charge in psilocybin and psychedelic-assisted therapeutics.    

Proactive: What is Mydecine’s value proposition and why should investors care?

Mydecine has a very unique approach — we are focused on first and second-generation therapeutics derived from psychedelic molecules. The reason why this is important is our paths to approval. We have both short and long-term goals on that path and obviously the infrastructure to support both initiatives.

In our first generation, we are already in a Phase 2A PTSD and a late-stage addiction study. There’s our MYCO–001, a pure psilocybin from natural fungal sources. For the first time, a company has been able to take a natural fungal source, extract the psilocybin and take it down to 99.9% purity so it is analogous to the synthetic versions of the COMP360 products that are out in the market in clinical studies. But remember we are pulling it from a natural source, so we have full freedom to operate without infringing on any patents.

We have novel approaches to our second generation of medicines. We address things like controllability, reducing the experience time down to a more controllable hour or two depending on the indications — safety rails and we look at things like shelf stability. Psilocybin has a single molecule — it is not oxygen stable. We've been able to address that problem. As a single molecule psilocybin is also not skin permeable, but we've tailored a molecule to permeate the skin through unique fast delivery mechanisms, while making the uptick time and controllability more accurate.

By acquiring NeuroPharm and Mindleap Health, Mydecine has increased its assets and diversified into telehealth. Will acquisitions be a part of your growth strategy?

There’s definitely going to be a number of M&A transactions and consolidations as the industry progresses. You have a company like Mydecine that is well along its journey to the NASDAQ. We've raised tens of millions of dollars and have very solid infrastructure globally with approved clinical sites. With our exclusive partnership with Applied Pharmaceutical Innovation and the University of Alberta, we can literally go from A-to-Z on drug development with full cGMP certified pharmaceutical manufacturing capabilities on-site and in-house as well. You are going to start to see this divide between new companies that have smaller balance sheets, but potentially good IP. And later stage companies like Mydecine that have larger balance sheets and are further along in their market journey who will be able to acquire a number of these companies.  

What is the kind of work that is being done at the Mydecine Center of Mycology?  

Our functional mushroom research happens in Denver, Colorado at our 7,500 square feet advanced mycology lab. This world-class lab is built around exploring medicinal mushrooms and the vast array of fungi medicinal compounds, which could potentially cure some of life’s biggest problems. We are looking at mushrooms like cordyceps, Lion's Mane, reishi and others. We are breaking them down to the molecular level and developing unique IP around different genetics and compounds.  

Our Chief Scientific Officer Robert Roscow is a well-known geneticist and worked at Canopy Growth and Ebbu where he ran their genetics division. He was the first to use CRISPR/Cas9 technology on the cannabis plant to isolate different character traits. We are doing the same thing with functional mushrooms and medicinal mushrooms, looking at what are the compounds of interest in these mushrooms.

You are evaluating PTSD, addiction, depression, anxiety, and other mental health conditions. Where are you with your clinical trials?  

In regard to PTSD, we have multiple global test sites — three in the US, three in Canada, which are all very well-known and prolific, and then there are two in Europe. We are carrying out clinical trials in three continents for the Phase 2A study of psychedelic treatments for PTSD in veterans and EMS personnel to achieve safer and more accurate psychedelic-led psychotherapy results in a supervised setting. We are waiting for final approval on our Investigational New Drug enabling studies before launching our Phase II PTSD clinical study this year.  

We are taking the value that is currently present in natural molecules, such as the psilocybin molecule in MYCO-001, and adding in patentable safety features. MYCO – 001 is likely to be used at mid to late-stage clinical trials. In addition, we have a later stage addiction study that we will be launching later this year, or early next year.  

So, you have an advanced clinical program calendar?

That is definitely a yes!

Mindleap is the only digital health platform that combines traditional telehealth with psychedelic medicine and mood, emotion, behavior tracking and analytics. Tell us about Mindleap.

We have invested significant time, money, and resources in Mindleap. We appointed William Cook as the interim CEO. At Raytheon, Cook designed the Patriot missile system software parameters for the US Army. He is a systems architect by profession and has a Master’s degree in marriage and family therapy. A West Point grad, Cook has been involved in massive builds and also has artificial intelligence expertise.

We have revamped Mindleap’s capabilities. At its core Mindleap was aimed at solving the issues that you have with psychedelic-assisted psychotherapy. You are looking at protocols that have tens of hours of psychotherapy associated with a single treatment. This is not accessible to everyday people as you have a limited number of locations/ketamine clinics where people can actually go and get treatments.

But when you look at the protocols, nine-tenths of the equation are therapy interactions between patient and therapist without any substance taken. These are interactions pre-and post-experience, and you have one or three possibly under the influence of a substance throughout the whole protocol. So, to be able to administer the treatments — seven, eight, or nine-tenths of the equation remotely — through a HIPAA-compliant telehealth app with trained professionals versed in the protocols is incredibly advantageous.

Mindleap 2.0 is set to launch in the coming weeks with more robustness to the platform. We have an educational platform that will share videos from top professionals, as well as audio clips with experts discussing what are psychedelics, how do they interact with our brains, what are the safety profiles of different substances, and what are the success rates? These are open questions and people don’t have easy access to professional advice.

Now you have this community-based app that individuals can go on for a low monthly subscription rate. They can not only access groups, and information, but find yoga, meditation, breathwork therapy classes, and ancillary services that promote overall mental health. We are incredibly excited about the overall product that we've been able to deliver.

Where do you see the psychedelic therapeutics industry five years from now, and what does this mean for your company?

You are going to see incredible advancement in the science behind these molecules and FDA approvals on a number of molecules for different indications — actually see real life treatments for individuals that have been suffering for ages with really no viable solution. We hope to be one of those making significant progress on clinical trials and the regulatory front.

Separately, one of the biggest hurdles to adoption is public acceptance of psilocybin and psychedelics. You're looking at a substance that’s been taboo and is talked about as a party drug. However, when you look at the safety profiles of these substances, comparatively speaking to serotonin reuptake inhibitors (SSRI), a class of drugs that are typically used as antidepressants, they're not even in the same ballpark in terms of their safety profile. Studies have shown that psilocybin and MDMA have no long-lasting effects.

Patients are also looking at one to three psychedelic-assisted therapy sessions to round out the whole protocol, compared to taking a pill every day of their lives. Most importantly, it is a curative solution, a very different proposition from popping a pill every day and feeling maybe better, maybe not! It’s a matter of time before the FDA grants approval for psychoactive compounds and psilocybin to be used therapeutically. Then you will see them enter the mainstream with profound implications for psychiatry and the treatment of mental disorders and addiction.