NetworkNewsWire Editorial Coverage: Before 1970, promising research was being conducted on the potential therapeutic effects of a broad category of psychedelic drug compounds, including substances such as psilocybin, DMT (dimethyltryptamine), LSD (lysergic acid diethylamide) and MDMA (methylenedioxymethamphetamine) — and then the Controlled Substance Act was signed into law, which labeled those substances as drugs of abuse with no medical value. The severely limited research conducted thereafter continued to demonstrate the potential of these compounds to provide therapeutic value, particularly for notoriously difficult diseases such as depression, addiction, PTSD and others. In the past few years, the relatively unattended field of psychedelic therapeutics is seeing a revival of activity and excitement, spawning innovative approaches and creating valuable companies in the process. Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile) is one of the exciting new companies to enter the public domain, bringing a diversified pipeline and de-risked strategy that should usher the company right into phase 2 clinical trials. A public company since its IPO in December of 2020, Tryp aims to become a leader in the healthcare and drug development industries alongside others, including COMPASS Pathways Plc (NASDAQ: CMPS), Field Trip Health Ltd. (OTCQX: FTRPF) (CSE: FTRP), Cybin Inc. (NEO: CYBN) (OTCQB: CLXPF), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED).
- Psychedelic therapeutics research is on the rise with a few companies standing out in a market forecast for 12.36% CAGR to reach $10.75 billion by 2027.
- Tryp is led by pharmaceutical experts with backgrounds in drug development utilizing FDA regulatory pathways.
- Tryp’s primary indications are fibromyalgia and eating disorders using its proprietary psilocybin formulation.
- Tryp’s pipeline is diversified, including non-psychedelic drugs like Razoxane, which is in development for soft tissue sarcomas.
Goodbye Stigma, Welcome New Generation in Healthcare
Most people may not recognize some of the medical terms for psychedelics, but nearly all know their street names, including magic mushrooms, ecstasy, Molly and LSD. Over decades, people have been conditioned to the stigma of these illicit substances, instigated and promoted by the Controlled Substances Act. However, the negative stigma is being lifted and being replaced by a growing body of scientific clinical evidence that strongly suggests psychedelics may well become one of the greatest advancements in mental health and neuropsychiatric disease in decades.
The mounting evidence of therapeutic value in psychedelics is following a similar path as medical cannabis, with pockets of decriminalization emerging in cities first with states following, as Oregon became the first state to legalize medical psilocybin (the active ingredient in magic mushrooms) in November. Likely just the start of a wave of acceptance and medicinal use, ResearchandMarkets.com forecasts 12.36% compound annual growth for the psychedelics drug market and expects the market to reach nearly $11 billion by 2027.
Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) offers a best-in-class, drug development team capable of taking compounds from early stage and advancing them through the rigors of clinical development to commercialization. This team of executives and advisors cannot go understated as it’s made up of deep experience and key leadership positions throughout, including large pharma, emerging pharma, drug approvals, psychedelics and capital markets.
Tryp will certainly benefit from the continued clinical research and data being collected on psychedelics to treat mental health, which further legitimizes efficacy. However, Tryp is not immediately focused on treating depression or PTSD like many other companies operating in the space. Management has the company uniquely positioned by recognizing blockbuster opportunities that exist in other indications with large unmet medical need that could potentially be treated with psilocybin including fibromyalgia and binge eating. Furthermore, Tryp has differentiated itself with a diversified pipeline that also includes a well-understood oral drug the company plans to develop for soft-tissue sarcomas.
Differentiated Indications and the Advantages of 505(b)(2)
Tryp’s multidimensional pipeline consists of its Psilocybin-for-Neuropsychiatric Disorders (PFN(TM)) program and Razoxane (TRP-1001) for soft-tissue sarcomas. The lead drug in the PFN program is TRP-8802, a synthetic, oral psilocybin medication initially being used to treat fibromyalgia, a condition of chronic widespread pain with no known cause.
Tryp is also collaborating with University of Florida’s Jennifer Miller, M.D. to initiate a clinical trial of TRP-8802 to treat the symptoms associated with certain eating disorders. In both cases, Tryp will be pursuing the FDA 505(b)(2) pathway to bypass preclinical and Phase I studies and move directly into Phase 2 clinical trials. The 505(b)(2) pathway is a streamlined process that allows drug developers to utilize work done by others to demonstrate the safety of a particular active ingredient. Relying on existing data eliminates unnecessary duplication of research and can save a company millions of dollars and years of studies compared to traditional pathways.
This is also the pathway Tryp will be seeking for TRP-1001 for soft-tissue sarcomas (“STS”). Razoxane belongs to the family of bis-dioxopiperazines, developed in the 1960s as derivatives of the chelating agent EDTA. As such, Tryp has decades of research to underpin and accelerate its development of TRP-1001 in a novel process.
Orphan Drugs, Large-Market Opportunities
Tryp is taking advantage of this accelerated regulatory pathway to develop treatments for both highly prevalent as well as rare diseases. Fibromyalgia is a condition of chronic widespread pain that impacts 6 to 12 million Americans annually with no known cause. Common treatments include muscle relaxants, antidepressants, anticonvulsants and anti-inflammatory drugs. This is a $3.6 billion market ripe for disruption as a new drug hasn’t been approved in over a decade.
Eating disorders are a tremendous market opportunity considering more than 30 million Americans will suffer from one. Tryp’s study at the University of Florida will also include hypothalamic obesity.
“Orphan” indications are rare diseases with few treatment options that affect fewer than 200,000 persons in the United States. Receiving an FDA orphan drug designation provides a bevy of incentives to a drug developer including expedited review processes, tax credits, extended period of exclusivity and waived fees, among others. Worldwide orphan-drug sales are forecast to make up 20% of the total prescription market in 2024 with sales reaching $242 billion.
Soft-tissue sarcomas (“STS”) is another orphan indication opportunity for Tryp. About 13,460 new soft-tissue sarcomas will be diagnosed, and it is estimated that 5,350 people will die of soft tissue sarcomas this year. The disease also comprises 7% of all cancer diagnosis in children.
World-Class Development Team
Gregory McKee recently came on as CEO and executive chairman at Tryp, bringing more than two decades of biotechnology, life-sciences-management and venture-investment experience to the company after filling executive positions with Torrent Ventures, CONNECT, Nventa Biopharma (merged with Akela Pharma) and Genzyme (acquired by Sanofi for $22 billion). Tryp co-founder and director James Kuo, MD, has extensive experience garnered from Pfizer, Discovery Labs, Myriad Genetics and as current chairman of ImmunoPrecise. President and chief science officer James Gilligan, PhD, brings 35 years of life-sciences experience to Tryp after co-founding Unigene Laboratories and the Bracken Group.
It is nearly impossible to adequately cover the entire Tryp C-suite, board and advisory team, all of which boast resumes similar to the aforementioned. Key members of Tryp management have held top executive positions and leadership roles at companies such as Pfizer, QLT, ImmunoPrecise Antibodies and many more. COO Tom D’Orazio has taken two cancer drugs through the Health Canada approval process. Vice president of manufacturing Larry Norder led chemistry aspects of early-stage R&D, preclinical and clinical developments for the blockbuster Naproxen. The impressive list goes on and on.
The company also recently added Dr. Robin Carhart-Harris, one of the world’s foremost experts in administration of psychedelic compounds, to its Scientific Advisory Board (“SAB”); Dr. Joel Castellanos and Dr. William Schmidt, both leading experts in drug development for chronic pain, also joined the company’s SAB earlier this year.
Tryp has attracted a team of luminaries and is on a collective mission to provide relief for serious medical conditions that have plagued the populace far too long without enough effective solutions. A team of this caliber may well be the answer to overcoming the magnitude of the problem.
Wall Street Wants In
The psychedelic revolution has begun. The evidence is everywhere. Venerable organizations like Johns Hopkins University and Imperial College of London are leading the charge and lending ever more credence to the safety and efficacy of therapeutic psychedelics. New venture firms are cropping up to pour cash into the space. Non-profit MAPS, the Multidisciplinary Association for Psychedelic Studies, late in 2020 raised $30 million from donors to conduct a Phase 3 clinical trial for PTSD using MDMA-assisted psychotherapy and recently reported positive results from the trial.
COMPASS Pathways Plc (NASDAQ: CMPS) was one of the first unicorns (companies with a $1 billion valuation) in the psychedelics space. The London-based company is developing a synthetic psilocybin (COMP360) administered in conjunction with psychological support for treatment-resistant depression, which has earned a vaunted breakthrough therapy designation from the FDA. COMPASS expects to have data from a phase 2b clinical trial for this indication by the end of 2021.
Field Trip Health Ltd. (OTCQX: FTRPF) (CSE: FTRP) is taking a different approach as a leader in the development and delivery of psychedelic therapies. Its Field Trip Discovery division is working on the next generation of psychedelic molecules and conducting advanced research on plant-based psychedelics including psilocybin-producing fungi. Its Field Trip Health division is building centers for psychedelic therapies. The company this month opened its fifth location in the United States, with construction commencing in other U.S. and Canadian cities.
Cybin Inc. (NEO: CYBN) (OTCQB: CLXPF) recently disclosed that it will be targeting Alcohol Use Disorder as the initial indication for its proprietary deuterated psychedelic tryptamine, CYB003, which is being developed in collaboration with NYSE-listed Catalent. The company has four psychedelics in its pipeline, including CYB001, which is planned to be evaluated as a sublingually administered version of psilocybin in Phase 2a and 2b clinical trials for Major Depressive Disorder.
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) is developing a diverse pipeline of psychedelic substances, including psilocybin, LSD, MDMA, DMT and an Ibogaine derivative called 18-MC. MindMed, which also has a valuation over $1 billion, last month graduated from the OTC to the NASDAQ, joining COMPASS as one of the few big-board listed psychedelic companies. This month, MindMed announced Project Angie, a new program where it will begin looking at LSD to treat pain conditions.
Those looking for innovation in healthcare are seeing it unfold before their eyes today. The excitement for therapeutic psychedelics is reaching a fever pitch as investors, academia, and scientists alike are all starting to realize the potential for psychedelics to change the healthcare landscape.
For more information about Tryp Therapeutics, please visit Tryp Therapeutics.
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