Mr. McKee has over 20 years of experience leading publicly traded pharmaceutical companies and brings a vast network of relationships in the life science industry that will accelerate Tryp Therapeutics' drug development activities. Mr. McKee began his life science career at Genzyme where he was responsible for commercializing leading compounds for rare diseases throughout Asia. He then served as Chairman and CEO of Nventa Biopharmaceuticals Corporation and Akela Pharma Inc., both publicly traded biopharmaceutical companies. Most recently, Mr. McKee spent significant time supporting early stage life science and digital health companies as CEO of CONNECT, an early stage incubator, and as Managing Director at Torrent Ventures, and biotechnology and life sciences venture fund. He was previously appointed as Chairman of the Board of Directors of Tryp in February 2021.
You have decades of experience in life sciences and drug development. What first got you excited about psychedelics and their therapeutic potential?
Nature often has a way of nudging us in the right direction when it comes to the development of novel pharmaceuticals, whether that's aspirin-containing willow bark, the derivation of penicillin, or psilocybin from mushrooms. Like a lot of people in the pharmaceutical industry, I had been aware of the early clinical research that was done on psychedelic compounds in the 1950's and 1960's at institutions like Johns Hopkins University. Now with a significant number of new academic researchers exploring the potential efficacy of these compounds in a variety of diseases with high unmet medical need, and that the FDA is evaluating the clinical merits of psilocybin and other psychedelics, I believe that we have an incredible opportunity to potentially create a new class of compounds to add to the arsenal that physicians have at their disposal to treat patients with these debilitating diseases.
What got you excited about the mission Tryp Therapeutics is on?
Our mission at Tryp is to use known, safe compounds to address the significant, unmet medical needs of patients suffering from a wide variety of conditions. Both of our active compounds, psilocybin and razoxane, have extensive safety data available from prior research. We're able to build on that foundation with our proprietary methods for synthesizing, formulating, and administering compounds for specific indications such as rare eating disorders and chronic pain for psilocybin, and soft tissue sarcomas for razoxane. I find this strategy exciting as it allows us to move through the clinical development process quickly and with confidence that we are headed in the right direction.
You’re helping bring Tryp into a new phase of growth, can you talk more about what plans you have for the future?
It's an amazing time for us at Tryp as we look at all of the opportunities in front of us. We expect to expand our proprietary psilocybin program to several additional chronic pain and central nervous system conditions. There are millions of patients worldwide who struggle daily with addressing their chronic pain, so no doubt there is great need. We will also continue to make significant investments into our intellectual property portfolio covering the manufacturing, formulating, and administering of our compounds--key innovations considering the general availability of psilocybin.
What can people expect from TRYP this year from your clinical programs and advancing your novel formulations?
We have a significant pipeline of collaborations with leading academic research institutions. We announced a partnership earlier this year with Jennifer Miller, M.D., at the University of Florida for clinical work for eating disorders and will be announcing several additional partnerships soon. We are focused on initiating two Phase 2a clinical trials this year in addition to expanding our portfolio of intellectual property.
As Tryp expands into the US public markets, what kind of possibilities will this open up?
Our shares recently started quoting on the OTCQB and are DTC eligible, so US investors are now able to purchase our shares directly from a domestic exchange. There's a large base of both individual and retail investors that are just learning about Tryp, so it's an exciting time for us to be able to share our story with them and our enthusiasm for our drug development pipeline. We also expect to attract US based, biotech focused institutional investors that have larger funds to deploy, significant technical understanding of our industry, and the wherewithal to remain invested in our company as we take our compounds through the clinical and regulatory processes required to commercialize novel pharmaceutical drugs.
TRYP has, arguably, the most drug development experience in the psychedelic medicine space. Can you tell us why that is an advantage for Tryp and how that’s helping position you as leaders?
We're fortunate to have a stacked team of scientists and advisors advancing our drug development pipeline led by our President and Chief Science Officer, Jim Gilligan, Ph.D. Our scientific team members have deep experience with developing pharmaceutical compounds and getting them approved by the FDA for marketing, which is unique in our field. We have also worked assertively to attract a large number of highly regarded scientists to our Scientific Advisory Board including Robin Carhart-Harris, Ph.D., Rachel Wevrick, Ph.D., Derek Ott, M.D. and William Schmidt, Ph.D. Also, we will continue to build a large number of academic collaborations with some of the top research institutes in the world.
What made the team at Tryp decide to focus on fibromyalgia as your lead indication for TRP-8802?
We believe that psilocybin has strong potential to address several pain-related conditions that are expressed through the central nervous system. Although fibromyalgia is highly prevalent, the available treatment options for the condition are only effective for a small portion of patients. With nearly 30% of fibromyalgia patients taking opioids to address their symptoms, we believe that the potential for psilocybin to repair pain signals in the brain was a much needed solution to develop.
Can you share how Tryp plans to advance your Phase II trial focused on psilocybin for eating disorders with the University of Florida?
We are currently finalizing the design for a Phase 2a clinical trial that will be conducted with the University of Florida for a number of rare eating disorders. Hyperphagia, for example, is a condition for which patients are never satiated no matter how much they eat. We believe that our novel psilocybin formulation can be effective at treating the underlying cause of these conditions.
What does it mean to have Dr Robin Carhart-Harris on the team and what advantages does he bring towards advancing the mission of Tryp?
Honestly, I don't believe there is a more knowledgeable or active researcher in the field of psychedelics than Dr. Carhart-Harris. His engagement with Tryp as a member of our Scientific Advisory Board is not only a strong validation of our clinical approach to developing our psilocybin program, but his active involvement has been critical in guiding our drug development strategy.
What do you believe is the most important thing for people to understand about the future of psychedelics as medicine?
I think it's important for people to understand that psychedelics have a strong safety profile, that Tryp and other companies are pursuing rigorous, clinical development for eventual FDA approval of our therapies, and that we are just scratching the surface with the indications that psychedelics can help address but what is clear is that the opportunity is far greater than just mental health, which is exciting. It's an incredible time to be part of something with such transformational potential, and especially exciting to be working in this field from essentially the ground up!