Tryp Therapeutics is a pharmaceutical company with two drug development programs that coalesce around the treatment of diseases with high unmet medical needs.
One program seeks to harness synthetic psilocybin for the treatment of neuropsychiatric disorders such as fibromyalgia, a debilitating condition that affects over 5 million people in the United States. Current treatments are ineffective or result in adverse side effects, leading around a third of fibromyalgia sufferers to use opioids to relieve their pain.
The company is also developing an oral formulation of razoxane for the treatment of soft tissue sarcoma: a cancer that has not been adequately addressed by a novel first-line therapy in over 40 years.
We spoke to Co-founder and CEO James Kuo about his company’s decision to develop a diversified drug pipeline, as opposed to solely focusing on mental health indications like many other psychedelics companies. We also discussed Tryp’s background and extensive drug development track record, their intention to utilise an accelerated regulatory pathway, Kuo’s primary goals for the company’s first year as a public company, and a whole host of other questions.
Psilocybin Alpha (PA): Can you explain your Psilocybin for Neuropsychiatric Disorders (PFN) program?
James Kuo (JK): PFNTM is Tryp’s proprietary drug development program for psilocybin in neuropsychiatric disorders. I think most of us are familiar with psilocybin so let me address the word neuropsychiatric in that program name. We utilize the term to refer to the intersection between neurological disorders and psychiatric conditions, which are rapidly merging. Psychiatric disorders like chronic pain and eating disorders are increasingly recognized as having an organic or structural component, even if it is difficult to define and non-discrete. We know that psilocybin shows great potential as a treatment of psychiatric disorders characterized by a disorder of consciousness. Our PFNTM program amplifies this mechanism to clinically test its application in disorders of pain processing and the hunger mechanism, both of which are mediated by the central nervous system.
PA: Your lead candidate for that program is TRYP-8802. What can you tell us about that formulation?
JK: TRYP-8802 is Tryp’s proprietary formulation of psilocybin for fibromyalgia. Intellectual property issues prevent me from going into much details of how we intend to formulate TRP-8802 but suffice it to say there are many unique standard industrial methods in the art to fine tuning a particular drug for specific clinical indications including dosage, salt form for stability, taste masking, excipients, enantiomers, dose titrating, improving oral bioavailability, slowing onset of pharmacological activity, etc.
PA: Most companies conducting research into psychedelic medicines are targeting mental health indications. Why has Tryp chosen to target a wide range of other indications like fibromyalgia, chronic pain, and eating disorders?
JK: Tryp selecting fibromyalgia to clinically test psilocybin gets to the heart of our strategy, which is leveraging psychedelics for disorders with high unmet medical needs with very few effective first line treatments. Fibromyalgia is just one of several chronic pain conditions that include medical oddities such as phantom limb pain. That particular disorder clearly illustrates that pain is centrally mediated as there is no limb sending a pain signal. Tryp’s strategy is to go where the medical need is greatest and the potential reward for patients as well as our investors will be the highest. We are ahead of our peers in the psychedelic sector in this regard and as we begin to announce our partnerships with some of the worlds leading centres of excellence in our indications, it will become apparent that the leading clinicians in these diseases categories we’re targeting share our enthusiasm for the potential of psilocybin as a therapy.
PA: Why might Tryp’s synthetic psilocybin be a better alternative to existing FDA-approved drugs for fibromyalgia?
JK: You have to understand that the three existing approved drugs for fibromyalgia suffer from two major deficits—they don’t work in most patients and they can have terribly adverse effects. The result is about 30% of fibromyalgia patients rely on opioids to control their pain. This is a sad state of affairs for a medical condition that is so widespread and debilitating. Making these people feel better should not be that difficult. In the 1960’s and 1970’s, psilocybin was shown in more than 1,000 published studies to have positive behavioural and clinical effects. Further research was curtailed for decades when it was classified as a schedule 1 drug, but that veil has been lifted and there is promising interest from experts in this indication that psilocybin could be used to help these patients.
PA: Your drug development pipeline isn’t solely dedicated to psilocybin, but also includes razoxane as a potential treatment for soft tissue sarcoma. Can you tell us more about that project?
JK: Yes, razoxane or TRP-1001 is a super exciting drug candidate for sarcoma. The reason we are excited is sarcoma is a backwater for cancer therapy. There has not been a new first-line therapy for this cancer in over 40 years. Amputation, old cancer drugs, and radiation are currently utilized yet the outcome is too often dismal and limited. Razoxane has been the subject of three published clinical trials conducted by investigators unaffiliated with Tryp. Our expertise is being able to review this medical literature and recognize the unprecedented opportunity razoxane represents when co-administered with other chemotherapies.
PA: Clinical trials take a great deal of time and capital to progress. Can you explain the “accelerated regulatory pathways” you plan to utilise?
JK: So there are really two items to establish in clinical trials–safety and efficacy. With our drug candidates, there is already a plethora of human safety data. Summarizing them should enable Tryp to largely avoid or abbreviate Phase 1 safety clinical trials, which are required for new chemical entities. Thus, we should be able to move into Phase 2 clinical trials where our objective is simple, establishing clinical proof-of-concept. The number of patients required to reach this goal should not be large. Since we don’t anticipate the need to run a large trial that has a long enrolment period, treatment period and follow-up. We will most likely utilize 2-3 clinical sites to ensure the robustness of our data and having that limited number should make training at each site easily manageable.
PA: Do you plan to steward drugs through all clinical trial phases?
JK: No. The entire breadth of clinical research and development is characterized as high cost, lengthy and fraught with risk. Accordingly, we intend to focus just on the value inflection point, which is Phase 2 Proof of Concept clinical trials. That is when we enroll just enough patients to show dramatic clinical efficacy. Afterwards, we intend to license, sell or partner for further development of our drug candidates. With this strategy, we de-risk the further development of the drug candidates and provide a return for investors within a reasonable time period.
PA: We understand that the majority of the R&D spend from the $4.5m IPO round will go toward the Psilocybin for Neuropsychiatric Disorders (PFN) program, with nearly 4x spend on the lead candidate in this program (TRP-8802) than the razoxane program (TRP-1101). Does this reflect the fact that psychedelics are your primary focus, or something else?
JK: Our drug candidates are like our children. They are different and each one has its strengths. We don’t have a drug within our portfolio that we don’t think will generate a significant return to investors. We don’t favor one over the other. That being said, it is self-evident that TRP-8802 does have multiple indications we will be pursuing so there is more spending on that particular drug candidate.
PA: Intellectual property is central to many psychedelic companies’ business strategy. Is this also the case with Tryp?
JK: Absolutely. The Tryp team members have spent their entire careers in the biopharma industry and everyone recognizes the critical importance that intellectual property plays in a successful drug development and commercialization plan. We don’t articulate about this part of our company because much of it is proprietary and happens behind the scenes. But we want to be completely clear that Tryp intends to file a series of patents for our drug development programs that in aggregate will create a dense thicket of defense from potential infringers.
PA: Many new psychedelics companies have emerged in the past year. What makes the team at Tryp qualified for this work?
JK: The reality is that psychedelics have been ignored for decades as a result of their categorization as a schedule 1 drug, until very recently, and it’s only just now that regulations have allowed for us to take the research that was done in Academia, and allow companies like Tryp and others to attract far larger pools of capital to fund research and continue exploring diseases which psychedelic therapies could provide breakthroughs for. At the core however, this industry is really mainly about drug development, the compounds that we are working with simply have to be psychedelic compounds, but the underlying framework for that work, and the industry we’re really talking about here is pharmaceutical development, which our team has decades of experience and success in. We are a uniquely qualified team, and experienced in everything from clinical trial development, to CMC Manufacturing, drug approvals and formulation, FDA pathways, M&A and licensing. I believe this gives us a competitive advantage as we move our portfolio of drug candidates forward, and we’re excited about the year ahead with what we know we have coming.
PA: What are your primary goals for the company in 2021?
JK: 2021 is a formative year for our company. It is the first year as a publicly traded company and we are excited to continue building shareholder value for our investors as we continue to progress our development pipeline. We are focused on our drug development plan and building our intellectual property portfolio around our indications. Our primary goal this year is to get our drug candidates into clinical testing so we can obtain initial efficacy data as soon as possible.
PA: Finally, what makes you most excited about leading Tryp?
JK: What has always excited me about the pharmaceutical business is delivering a groundbreaking new therapy to desperately ill patients. Basically, we have forever changed the practice of medicine and left the world a better place. Often there is a disconnect between the team responsible for developing a new drug and the physicians and their patients who use the drug. However, the knowledge of what we do is enough. From my perspective, conquering human diseases and helping people is the most rewarding and formidable challenge of our time, and a new era has begun around psychedelic medicine, with a pandora’s box of opportunity only just beginning to open up that for any physician or researcher is a once in a lifetime opportunity. We’re excited to be a part of it.
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