NEW YORK, Sept. 27, 2021 /PRNewswire/ — The emergence of psychedelic therapies as a popular investment a few years ago was mostly underscored by investors that rode the cannabis wave seeing a brand-new opportunity with drugs such as psilocybin, LSD, MDMA, DMT, and others to address hard-to-treat mental health diseases, namely depression, addiction, post-traumatic stress disorder, and anxiety. As strides are being made on those fronts, a second investment wave is swelling on the horizon that looks to feature expanded indications and bring new therapeutic options to diseases with unmet needs. Psychedelics could redefine standards of care for chronic diseases and reshape psychiatry, including counseling practices, among other things. Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile) is leading this next wave of psychedelic drug development beyond mental health into chronic pain and eating disorders as the company advances its clinical programs. With a diverse approach, Tryp is joined by a short list of brand name leaders in psychedelics that includes ATAI Life Sciences N.V. (NASDAQ: ATAI), COMPASS Pathways Plc (NASDAQ: CMPS), Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ) and Cybin Inc. (NEO: CYBN) (NYSE American: CYBN), all of which are making significant strides towards validating the legitimate potential of a wide range of psychedelic-based treatment regimens.
- Psychedelic drugs are amid a renaissance that will see revenues rise from $2.82 billion in 2020 to $7.57 billion by 2028.
- Tryp Therapeutics is pursuing five indications in chronic pain and other indications with total estimated annual sales potential of more than $12 billion.
- Tryp has announced the submission of an investigational new drug (IND) application for its Phase 2a clinical trial in overeating disorders, is preparing to file another IND for a Phase 2a clinical trial targeting fibromyalgia.
- Tryp has partnered with the University of Florida to conduct a Phase 2a trial for overeating disorders, and with the University of Michigan for its fibromyalgia clinical trial.
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New Opportunities Unlocking Value
Market analysts are bullish on the rapid growth in the global psychedelic drugs market. Data Bridge Market Research foresees a 13.3% compound annual growth rate for the market to rise from $2.82 billion in 2020 to $7.57 billion by 2028. Analysts at Data Bridge see a rising prevalence of depression and anxiety as key drivers. Again, while depression and anxiety indeed represent blockbuster drug potential and huge addressable markets, they are only scratching the surface.
On Wall Street, investors are putting premium dollars on psychedelic companies within the biotech industry. Per Psilocybin Alpha, the aggregate value of psychedelic companies listed on the NYSE and NASDAQ exceeds $7 billion.
Innovative companies are looking outside the box to differentiate themselves from the pack and capitalize on the robust therapeutic properties of psychedelics. For instance, research is underway to evaluate the use of psychedelics for Parkinson’s disease, Alzheimer’s and other forms of dementia where there are currently limited options with diminishing returns to address the symptoms. While not being used for cancer, psychedelics are being evaluated to help patients better manage grief associated with cancer diagnoses.
Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is pursuing five indications in chronic pain and other indications with total estimated peak worldwide sales potential of more than $12 billion. Tryp expects to initiate two Phase 2a studies in 2021 and two more in early 2022 focusing on these indications. Despite four upcoming mid-stage clinical trials, the company remains relatively unsung among its much higher capitalized peers, as evidenced by a market capitalization under C$25 million.
In addition to leading a second wave of innovation extending beyond mental health disorders, Tryp distinguishes itself by developing its proprietary psilocybin-based drug product. The company’s drug candidates currently in development include 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.
Tryp can also trumpet an exclusive supply chain by which it procures active ingredients and drug products in quantities sufficient for clinical trials and commercialization, should the drug be approved. This is a rare capability among psychedelic drug-development companies. The integrated cGMP supply chain affords Tryp another unique opportunity with potential to act as a supplier of synthetic psilocybin to the global research community.
Blockbuster Opportunities in Pain Treatment
ResearchandMarkets.com estimates revenue in the global chronic pain treatment market to progress 6.5% annually from 2020 to reach $151.7 billion in 2030. Tryp is focusing its efforts on areas of unmet medical need in this space, targeting fibromyalgia, phantom limb pain and complex regional pain syndrome, each of which are blockbuster opportunities with the potential to generate over $1 billion in annual peak sales. Tryp intends to submit an investigational new drug (IND) application with the FDA for a Phase 2a clinical trial with the University of Michigan in fibromyalgia patients during Q4 of this year.
The National Fibromyalgia Association estimates more than 10 million Americans suffer from fibromyalgia. Existing treatments, such as prescription opioids, exercise and stress management, are mostly ineffective at best and deadly at worst considering opioids are commonly prescribed to help patients with their pain. This is a market ripe for disruption by psychedelics, with reason for optimism as anecdotal evidence is mounting that supports the potential usefulness of psilocybin for fibromyalgia.
Going forward, Tryp intends to pursue clinical research in phantom limb pain and complex regional pain syndrome (CRPS). It is estimated that 1 million people in the United States suffer from phantom limb pain, including more than 60% of amputees. CRPS results from a misfiring of pain signals in the brain after injury, surgery, stroke or heart attack. A rare disease, about 200,000 people in the U.S. are affected by CRPS each year. As with fibromyalgia, existing treatments leave a lot to be desired.
Overeating Disorders and a Major Milestone
After recently filing an IND application with the FDA, Tryp is staring at another major milestone. The company anticipates that its first clinical trial evaluating TRP-8802 will begin enrollment and dosing patients in Q4 of this year. This Phase 2a study will evaluate patients with overeating conditions including binge eating disorder and hypothalamic obesity. For the trial, Tryp has partnered with a leading expert in the eating disorder space, Dr. Jennifer Miller at the University of Florida Division of Endocrinology.
Affecting up to 3.5% of females and 2.0% of males, binge eating disorder is a result of addictive behaviors toward food that can be difficult for patients to break. Hypothalamic obesity is characterized by damage to the hypothalamus, the part of the brain that produces hormones that control hunger. This disorder is estimated to affect less than 5,000 people in the U.S. every year, yet there are no available treatment options for the disease. This means that Tryp could potentially utilize all available accelerated FDA development pathways.
Reaching Milestones Reduces Risk, Increases Value
In the course of drug development, there are key milestones with each human study including submitting an IND with and receiving acceptance by the FDA; enrolling the first patient in the trial; and then the final data readout at the end of a clinical trial. The FDA’s expected green light to move forward with the University of Florida study places Tryp in an elite group of companies conducting Phase 2 trials for psychedelic drugs, and positions the company as a pioneer in the field of psychedelics for chronic pain and overeating disorders.
There are no assurances in clinical trials, but a drug moving through the clinical progression tends to build value for a company with each major milestone that is reached because of the potential for future revenue. Effectively, 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.
Phase 1 studies are performed to prove a drug is safe. Phase 2 determines the efficacy at specific dosing levels for specific indications. Phase 3 is similar to Phase 2 in purpose, only evaluating larger patient populations. In Tryp’s case, the safety profile of psilocybin is well established, meaning the company can bypass Phase 1 and proceed right into Phase 2 trials. If the company meets its goals of initiating four clinical trials by the first half of 2022, Tryp could be on par with companies with market capitalizations that are 10-fold (or more) larger than its own.
The Psychedelic Renaissance Is Now
The renaissance in psychedelic research is upon us after decades of being on the back burner with a resurgence in clinical work that has provided compelling data for mental health indications in studies involving hundreds of patients. Look for that to continue and for clinical studies to continue unlocking the therapeutic potential of psychedelics beyond mental health.
ATAI Life Sciences N.V. (NASDAQ: ATAI) which counts PayPal founder Peter Thiel as an investor, was founded in 2018 to accelerate development of psychedelic drugs and companies. The Germany-based company has its hands in many different drugs via investments in nearly a dozen companies at various stages of development. On September 14, ATAI announced the initiation of a Phase 2a clinical study to evaluate the safety and efficacy of PCN-101 (R-ketamine). R-ketamine is a stereoisomer of ketamine being developed for therapeutic treatment of psychiatric disorders such as treatment resistant depression.
COMPASS Pathways Plc (NASDAQ: CMPS) is one of the best-known names in the psychedelics business. The company has the psychedelic community watching for results from its Phase 2b clinical trial, which is the largest human trial of synthetic psilocybin to date, enrolling 233 patients with treatment resistant depression across 22 sites in 10 countries. Topline data is expected during the fourth quarter.
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) was the third brand-name company to list on Nasdaq over the past year, following COMPASS and ATAI. Most recently MindMed has agreed to work with NASDAQ-listed Forian Inc., a leading provider of evidence-based support for more comprehensive clinical and commercial decision-making. MindMed and Forian will collaborate to develop best practices for using real-world evidence information to help improve the health and lives of psychiatric patients.
Cybin Inc. (NYSE American: CYBN) (NEO: CYBN), (NEO: CYBN)which has only been public since November 2020, made the move to a senior exchange last month, graduating to the NYSE American on August 5, 2021. Cybin’s current indications in its psychedelic pipeline include major depressive disorder (CYB001), alcohol use disorder (CYB003) and anxiety disorders (CYB004). In addition, two programs in the research phase (CYB005 and CYB006) involved synthesis and testing of more than 50 novel compounds coupled with extensive in-vitro and in-vivo pharmacokinetic, receptor binding, behavioral and safety evaluations.
For proponents, the stigma fading away from psychedelics is brilliant progress allowing clinical trials to start reaching an advanced stage. That means the world sits at an inflection point and on the cusp of normalization of physician-administered psychedelic drugs, and these are some of the companies that are shepherding that transition.
For more information about Tryp Therapeutics, please visit Tryp Therapeutics Inc.
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