NEW YORK, Sept. 29, 2021 /PRNewswire/ -- The fact that psychedelics is a nascent industry doesn't seem to be discouraging savvy investors exploring the opportunities. A recent Fortune article noted that "despite being an industry in its early stages, the potential for psychedelic health care is growing, with the market projected to reach $10.75 billion by 2027... Smart capital is moving in to take advantage of the opportunity to invest in the next frontier." The multibillion-dollar potential combined with solid promise in psychedelic drug treatments, particularly in the hard-to-treat mental health sector, such as depression, addiction, post-traumatic stress disorder and anxiety, bodes well for pioneering psychedelic companies, including Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile). Tryp is one of a handful of companies focused on psychedelics; others venturing forward in the space include Seelos Therapeutics Inc. (NASDAQ: SEEL), Field Trip Health Ltd. (TSX: FTRP) (OTCQX: FTRPF), Small Pharma Inc. (TSX.V: DMT) and Mydecine Innovations Group Inc (OTC: MYCOF).
- Psychedelic drugs projected to see revenues rise from $2 billion in 2019 to $6.8 billion by 2028.
- Tryp Therapeutics is pursuing chronic pain and other indications that extend beyond mental health with total estimated annual sales potential of more than $12 billion.
- Tryp has submitted an investigational new drug (IND) application for its Phase 2a clinical trial in overeating disorders, and plans to file an IND for a Phase 2a clinical trial targeting fibromyalgia.
- Tryp is partnering with the University of Florida on Phase 2a trial for overeating disorders and with the University of Michigan for a fibromyalgia clinical trial.
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The Fortune article noted that projections for the psychedelic industry vary, with a recent Data Bridge Market Research reporting that the market is growing with a CAGR of 16.3% from 2020 to 2027, expected to reach $6.8 billion by 2027, up from $2 billion in 2019. Another report from Research and Markets was even more optimistic, forecasting that the psychedelic drugs market would reach $10.75 billion by 2027, growing at a CAGR of 12.36% during 2021–2027.
"Growing acceptance of psychedelic drugs for treating depression and increasing prevalence of depression and mental disorders are the factors for the market growth," the article stated.
Psychedelic pioneers are working to establish strongholds in the space, confident that research and popular opinion will dovetail, creating an ideal place to be in mental health treatment. Studies focused on the seemingly vast potential of psychedelics increase almost daily as savvy companies look to leverage their strengths and make the most of new breakthroughs. Recent research has focused on using psychedelics for the treatment of Parkinson's disease, Alzheimer's and other forms of dementia, which currently offers limited options with diminishing returns to address the symptoms. Psychedelics are even being studied for potential in helping patients better manage grief associated with cancer diagnoses.
Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is leveraging its expertise as it pursues indications in chronic pain and other indications with estimated worldwide sales potential totaling more than $12 billion. Tryp plans to focus on these indications with two Phase 2a studies scheduled for this year, with two more planned for early 2022. Even with the potential provided from its four upcoming mid-stage clinical trials, the company appears to be overlooked among its much higher capitalized peers, as evidenced by a market capitalization under C$25 million.
Clinical trials aren't the only way Tryp is setting itself apart. The company is in the process of developing a proprietary psilocybin-based drug product, with two drug candidates currently in development: TRP-8802, a standard oral form of synthetic psilocybin, and TRP-8803, a patent-pending formulation with a novel route of administration that is expected to improve the patient experience.
In addition, Tryp boasts an exclusive supply chain by which it obtains active ingredients and drug products in quantities sufficient for its slated clinical trials as well as planned commercialization. This is a rare feat among psychedelic drug-development companies as the supply chain is deeply impacted by numerous factors. Tryp's integrated cGMP supply chain is yet another component of the company's potential to act as a supplier of synthetic psilocybin to the global research community.
Focused on Areas of Unmet Need
A recent ResearchandMarkets.com report estimated revenue in the global chronic pain treatment market to increase 6.5% annually from 2020 to 2030, when it is projected to total $151.7 billion. Those numbers provide an attractive backdrop for Tryp, which is focusing its efforts on areas of unmet medical need in this space.
Specifically, the company is eyeing the fibromyalgia, phantom limb pain and complex regional pain syndrome (CRPS) spaces, each of which look to provide blockbuster opportunities with potential to generate more than $1 billion in annual peak sales. Tryp anticipates submitting an investigational new drug (IND) application with the FDA in Q4 for a Phase 2a clinical trial focused on fibromyalgia patients. The company is conducting the study with the University of Michigan with the enrollment of first patients for the study expected in 2022.
Recent stats from the National Fibromyalgia Association indicate more than 10 million Americans suffer from fibromyalgia. Common treatments include prescription opioids, exercise and stress management, which are often ineffective at best and even deadly, considering opioids are commonly prescribed to help patients with their pain. This sector is ripe for psychedelic innovation, especially as anecdotal evidence appears to strongly support the potential power of psilocybin to treat the condition.
In addition, Tryp plans to pursue clinical research in phantom limb pain and complex regional pain syndrome (CRPS). Reports indicate that 1 million people in the United States suffer from phantom limb pain, including more than 60% of amputees. A relatively rare disease, CRPS is rooted in a misfiring of pain signals in the brain after injury, surgery, stroke or heart attack; an estimated 200,000 people in the U.S. struggle with CRPS each year. As with fibromyalgia, current treatments could be improved upon.
Moving Toward Milestones
After recently filing an IND application with the FDA, Tryp is also moving toward another major milestone later this year. The company plans on enrolling and dosing patients in its first clinical trial evaluating TRP-8802. This Phase 2a study will study patients with overeating conditions such as binge eating disorder and hypothalamic obesity. Tryp is working with a leading expert in the eating disorder space, Dr. Jennifer Miller at the University of Florida Division of Endocrinology, to conduct this trial.
Binge eating disorder impacts up 3.5% of females and 2.0% of males and is an addictive food behavior that is difficult for patients to stop. Hypothalamic obesity is characterized by damage to the hypothalamus, the part of the brain that produces hormones that control hunger. While affecting fewer than 5,000 people in the United States every year, the disease has no available treatment options, creating an open opportunity where Tryp could potentially utilize all available accelerated FDA development pathways.
Joining an Elite Group
Critical milestones in the process of drug development and human studies include submitting an IND with and receiving acceptance by the FDA; enrolling the first patient in the trial; and then gathering final data readout at the end of a clinical trial. The FDA's expected approval to move forward with the University of Florida study means Tryp joins an elite group of companies conducting Phase 2 trials for psychedelic drugs, positioning the company as a pioneer in the field of psychedelics for chronic pain and overeating disorders.
While there are no sure things in clinical trials, having a drug moving through the clinical progression often builds value for a company, especially as the study moves through each major milestone. The potential for future revenue increases while the risk profile decreases incrementally with each positive development, so shares rise, much like Nasdaq-listed Vaxart's did on August 2, 2021, with an IND approval.
Briefly, successful Phase 1 studies prove a drug is safe, Phase 2 determines the efficacy at specific dosing levels for specific indications and Phase 3 is similar to Phase 2 in purpose but evaluates larger patient populations. In Tryp's case, the safety profile of psilocybin is well established, meaning the company can skip Phase 1 and proceed right into Phase 2 trials. If Tryp meets its goals of initiating four clinical trials by the first half of 2022, the company could be on par with companies with market capitalizations that are 10-fold (or more) larger than its own.
A Promising Space
The new frontier of psychedelics has arrived with growing popular acceptance and a significant increase in research has provided compelling data for mental health indications in studies involving hundreds of patients. It is evident that now is the time for both savvy investors and companies to consider the potential for this promising space.
Seelos Therapeutics Inc. (NASDAQ: SEEL) is a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases. This summer, the company announced that it was included in the first U.S.-listed Exchange Traded Fund (EFT) focused on psychedelics. The fund began trading on May 28, 2021. Seelos' inclusion in the fund was based on its lead program SLS-002 (intranasal racemic ketamine), which recently released positive top-line data from Part 1, the open-label cohort, of its potentially registrational proof-of-concept study for acute suicidal ideation and behavior (ASIB) in patients with major depressive disorder (MDD).
Small Pharma Inc. (TSX.V: DMT), a neuropharmaceutical company focused on psychedelic-assisted therapies, has also been included in an inaugural ETF. The company announced that AdvisorShares(R) Investments LLC, a leading sponsor of actively managed exchange-traded funds, has included Small Pharma in the launch of its AdvisorShares Psychedelics ETF (PSIL). In addition, Small Pharma has released information regarding the successful completion of the Phase I part of the combined Phase I/IIa clinical trial and the initiation of the Phase IIa part in combination with psychotherapy of its lead candidate, SPL026, for the treatment of major depressive disorder.
Field Trip Health Ltd. (TSX: FTRP) (OTCQX: FTRPF) has announced that the lead indications for FT-104, its novel psychedelic compound in development, will be treatment resistant depression (TRD) and postpartum depression (PPD). A global leader in the development and delivery of psychedelic therapies, Field Trip is developing next-generation psychedelic molecules. Its first molecule in development, FT-104, a prodrug, is a synthetic serotonin-2A (5HT2A) agonist whose active component has serotonin-2A potency similar to psilocybin.
Mydecine Innovations Group Inc (OTC: MYCOF) has filed its final patent application with the United States Patent and Trademark Office and the World Intellectual Property Organization for one of its lead drug candidates, MYCO-003. In addition, the company reported positive preclinical data supporting the continued development of MYCO-003. This patent-pending formulation has the potential to further reduce patient anxiety as compared to pure psilocybin, when used in therapy or medical practice. Mydecine, a biopharmaceutical company focused on the treatment of mental health and addiction, is developing MYCO-003 to offer enhanced treatment of anxiety and post-traumatic stress disorder (PTSD).
As psychedelic research continues to move forward and clinical trials start reaching advanced stages, companies operating in this space will likely gain additional attention from investors, patients and health providers alike.
For more information about Tryp Therapeutics, please visit Tryp Therapeutics Inc.
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