Evan Levine | Chairman & CEO, PsyBio Therapeutics

Evan Levine is the co-founder and CEO of PsyBio Therapeutics. Prior to joining PsyBio, Evan was the managing partner at Brown Simpson Asset Management and Chief Executive Officer of Adventrx Pharmaceuticals.
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What made you personally excited about psychedelics?

I believe everybody should be  excited about the resurgence in research of psychedelic plants and fungi. Psychedelics  have been a beneficial part of human history for thousands of years. They are referenced in early art and during biblical times and have played a key role in modern history solving  mathematical, scientific, and technological challenges. We actually have a biological  relationship to these plants and fungi. Certain psychedelic medicines were pharmaceutically  synthesized in the 1950s and 60s and were examined ad nauseam for indications such as  depression and addiction and showed encouraging efficacy. It was extraordinarily disappointing that the research was practically halted in the 1970s but underground  pioneers continued to persevere at their own risk of legal exposure. We are very fortunate to  have that part of history in our rear view mirror and look forward to the opportunity when these medications can be made available to the public under safe manufacturing practices. 
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In my personal opinion, not of the company’s, I believe that some of these compounds actually heal, not just treat symptoms which is the case with most pharmaceutical products.  

What do you see as the potential impact psychedelics will have on healthcare as a whole and what kind of therapeutic potential do they have?

Beyond their anticipated healing  powers, psychedelics have been used both recreationally and spiritually. These molecules  appear to be very safe, nonlethal and nonaddictive. Dozens of clinical trials are currently testing myriad compounds in various indications. We have some early academic data suggesting superior efficacy versus standard of card in certain disorders. The industry has a  long way to go on understanding how to administer these powerful medications but the data  is encouraging. I am highly confident that some of these products will be approved for use by the major heath regulatory agencies. However, when it comes to approving new pharmaceuticals, evidence and data will be the final arbiter.  

What is PsyBio focused on building?

PsyBio Therapeutics is building a pure play  biopharmaceutical company that is discovering and developing a portfolio of both natural  and non-natural tryptamine related compounds. The team has extensive background in drug  development from bench science to commercial manufacturing to pivotal human studies. We are conglomerating that experience and expertise and developing new and exciting medications that we anticipate to be superior to standard of care. The company has a novel  and inventive platform technology that enables the efficient biosynthesis of psilocybin and  other tryptamines leveraging molecular engineering and genetically modified organisms. We are already into commercial manufacturing in two of our molecules and are planning our initial  FDA interactions in the coming months in anticipation for clinical trials of these extraordinary, unique compounds.  

How would you describe PsyBio’s approach to the psychedelic space?

PsyBio Therapeutics is extraordinarily unique in comparison to other companies grouped in the new psychedelic industry. There are very few biotechnology companies that are developing protectable technology. Patents are a real challenge for the industry as a whole. Our platform  technology is the only discovery methodology that we are aware of that can efficiently and  inexpensively produce these drug candidates from a prokaryotic host. We have filed and continue to prosecute new intellectual property from methods to compositions of matter. We have an entire team in both the Chemical Engineering and Psychology departments at Miami University including a vivarium at the university and are in the process of expanding  laboratory space in Southern Florida.  

Can you talk more about your unique bacterial biosynthesis process for psilocybin and what  advantages it has over other methods?

Our platform technology is based on using specific production genes and delivering them to a recombinant host. Specifically for psilocybin, our method can produce the molecule far cheaper, faster and greener than any other published or patented methods that we are aware of. There are certainly other systems to generate psilocybin but we believe that PsyBio has the superior methodology. Based on public data and knowledge, other methods such as growing, extraction and chemical synthesis are far less efficient, far more expensive and put much more of a burden on the ecological system versus our techniques.  

How is your method of bio synthesization ‘greener’ than other methods of biosynthesis? 

Putting aside extraction which is reliant on farming, regarding production of psilocybin specifically, chemical synthesis is the competition. In order to chemically synthesize the drug some of the process includes using toxic heavy metal solvents, reagents and catalysts which have waste disposal challenges for the environment. We introduce target producing genes and genetically modify the bacteria. It is a one pot autocatalytic process that grows extracellular psilocybin in the just a few days.
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In comparison, the chemical synthetic takes much longer and involves multiple unstable intermediate reactions and purification steps.  

You’re developing a variety of novel tryptamine compounds, what stage are you in when it  comes to studying and developing these molecules?

This is what truly drives my excitement to be a part of this company. Over the past couple of years, magic mushrooms have become a  household word – they have completely interwoven themselves into the zeitgeist. As the magic mushroom has become more prominent in the dialect, many people have learned  that the psychoactive ingredient in the hallucinogenic mushroom is psilocybin. That is true  but only partially valid. There are other metabolites within the fungus that agonize psilocybin  and have unique properties of their own. We are re-engineering the ratios of these other intermediates and endeavoring to create improved therapeutics. We have already communicated to the public that psilocybin and norbaeocystin in combinations far different than nature offer a more efficacious response than mono psilocybin and we have far more that we intend to disclose over the coming year.
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We have initiated process development and scaling and will be submitting our pre-IND package to the FDA in the coming months. We are hopeful and anticipate that our platform technology will yield a plethora of new therapeutic medications across a wide variety of health challenges and we continue to build our intellectual property portfolio around this.  

What is your treatment focus when it comes to tryptamine based compounds?

Who do you think will benefit most from these new medicines and how are you developing them to have therapeutic potential? We are a pure play drug development company that is discovering and developing new medications. Of course, we consider the method of administration and different indications but I think this is going to be highly variable in how the treatments are  delivered. Whether they be dosed in a clinical or professional setting or in the patient’s personal space is going to be determined after far more evidence and data are generated. 
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My personal view is that some of these compounds have extraordinary therapeutic potential but the permutations on that comment are infinite. Factors such as set and setting,  psycholytic therapy and even more important than those two variables, dosing levels of any particular product, are many years away from statistical determination. Although the  research has been going on for decades, I really think this is the genesis.  

What is the most common misconception you hear about psychedelics?

There is a tale that seems to have been perpetuated about believing you can fly on LSD and are at risk of jumping off a building. I don’t know whether this ever happened but my guess is that it probably did with the billions of doses that have been ingested. These are very powerful  compounds, especially at higher doses, so the fear of bad trips, ego dissolution and  frightening visuals are a real risk but those factors are also part of the healing process and these drugs need to be used and treated with respect in order to extract their potential.

What do you believe is the most important thing for people to understand about the future of psychedelics as medicine?

Remarkably simple, pending data and evidence. Everything else is noise or profiteering.