Companies Smashing the Psychedelic Ceiling

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Jul 29, 2021, 08:30 ET

NEW YORK, July 29, 2021 /PRNewswire/ -- It's early on in a burgeoning market, but there is certainly reason to be optimistic about the future of psychedelic medicines as a promising treatment for a broad spectrum of diseases and conditions. In fact, some breakthroughs may be closer than initially anticipated. After decades of stigma from their recreational use, psychedelics are now gaining momentum for medical applications as the U.S. Food and Drug Administration has signaled its intent to evaluate the compounds based on the merit of their clinical efficacy. The range of target indications is widening, the number of studies for different types of psychedelics is growing and specialized clinics are cropping up, a trio of signals that approved medical applications of psychedelics may be here before long. The diversity of approaches makes the market particularly interesting for psychedelic market participants. For instance, Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (Profile) is studying how its novel technologies address chronic pain and eating disorders — two areas that have been particularly elusive for traditional drug makers. Seelos Therapeutics Inc. (NASDAQ: SEEL) is looking at a new spin on ketamine for certain types of depression, while Awakn Life Sciences Corp. (NEO: AWKN) and Field Trip Health Ltd. (TSX: FTRP) (OTCQX: FTRPF) are in the clinics and R&D businesses, and Small Pharma Inc. (TSX.V: DMT) is evaluating other psychedelics for depression.

Most psychedelic drug developers are working on drugs for mental illness, particularly depression; Tryp is targeting chronic pain and eating disorders.
Tryp Therapeutics is advancing novel drug candidates made from psilocybin, the psychedelic component found in magic mushrooms.
Tryp expects to submit two separate INDs this year for upcoming Phase 2a clinical trials.
Only an elite group of companies have initiated Phase 2 clinical trials exploring psychedelic-related compounds; those companies' valuation ranges from $85 million to $2.5 billion versus Tryp's $31 million.

Click here to view the custom infographic of the Tryp Therapeutics Inc. editorial.

Psychedelic Catalysts

Psychedelics reached an inflection point in 2018 when the FDA tagged psilocybin, the hallucinogenic compound found in "magic" mushrooms, with a Breakthrough Therapy designation to treat depression in patients who didn't meaningfully respond to two different types of antidepressant therapies. The vaunted designation is a priority review pathway reserved for new drugs believed to offer a substantial improvement over anything on the market today. The designation lent a great deal of credence to a compound still categorized as a Schedule I drug under the Controlled Substance Act, a categorization that restricts the use of the compound and criminalizes its possession outside of medical applications. A second Breakthrough Therapy designation followed in November 2019 for the treatment of major depressive disorder.

Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) is optimistic that psilocybin can be beneficial in other large markets where patients and doctors alike are eager to see alternatives to the lackluster drugs available today. Headquartered in San Diego, California, Tryp has assembled a team of veritable experts in its C-suite and scientific advisory board, which is chaired by Dr. Robin Carhart-Harris, one of the world's leading minds in psychedelic medicines. Dr. Carhart-Harris also serves as director of the Neuroscape Psychedelic Division at the University of California, San Francisco as well as founder and head of the Centre for Psychedelic Research, Division of Brain Sciences, at Imperial College London where his work was part of which supported the first Breakthrough Therapy designation for psilocybin.

Tryp's TRP-8802 and TRP-8803 are the flagship products of the company's Psilocybin-for-Neuropsychiatric Disorders, or PFN program. TRP-8802, a standard oral form of synthetic psilocybin, is being developed for several different indications, including chronic pain (more specifically, fibromyalgia) and eating disorders. TRP-8803 is a patent-pending psilocybin-based product being developed by Tryp with a unique formulation and novel route of administration. The expectation is that TRP-8803 will be able to improve the experience for patients receiving psychedelic therapies versus that of conventional oral administration. Tryp will be using TRP-8802 for its Phase 2a clinical trials and expects to use TRP-8803 for Phase 2b studies and beyond.

The development strategy involves leveraging the known safety and pharmacokinetic profiles of psilocybin to jump right into Phase 2a trials — a stage of studies that aims to demonstrate the efficacy of psilocybin for the targeted indications. To do so, Tryp has teamed up with leading companies whose expertise will be invaluable in its development. Curia (formerly AMRI) is manufacturing the active pharmaceutical ingredient (API) for the synthetic psilocybin that is the basis for the PFN program. Alcami will develop the analytical methods and final drug products. Fluence is handling the psychotherapy designs for the trials. Clinlogix has been retained as the Contract Research Organization (CRO) for the planned Phase 2a studies. Furthermore, Tryp is partnering with world-leading academic institutions to conduct the trials: the Chronic Pain & Fatigue Research Center at the University of Michigan for fibromyalgia and the University of Florida for eating disorders.

Time for New Pain Relief

As companies position themselves for different indications with different compounds, Tryp is a first mover with plenty of runway to pull away in the areas of chronic pain and certain eating disorders. Within the chronic pain category, Tryp has its sights initially set on fibromyalgia, a common (~4 million U.S. patients), complex disease characterized by widespread musculoskeletal pain, fatigue, body tenderness, memory problems and sleep disorders. A true pioneer, Tryp has partnered with the University of Michigan to lead the world's first Phase 2 clinical trial for a chronic pain indication using a psychedelic compound.

The source of fibromyalgia is not known, but one commonly accepted overarching thesis is that people with the condition process pain differently. Without addressing the source, painkillers are commonly prescribed, but only mask the pain. Unfortunately, that puts fibromyalgia patients at risk of opioid addiction and falling into an opioid epidemic that claims more than 50,000 American lives by overdose annually. Looking at the stats shows how badly this market needs safer alternatives. Approximately 30% of fibromyalgia patients (~1.2 million Americans) are prescribed opioids for their pain. After a year of therapy, owing to ineffectiveness and unpleasant side effects, only about 10% are following their physician's care plan.

Tryp intends to have an Investigational New Drug (IND) application filed with the FDA this quarter for the upcoming Phase 2a trial with the University of Michigan. The university will also conduct research to advance the development of TRP-8803 for the purpose of expanding Tryp's patent portfolio and for use of TRP-8803 in Phase 2b and subsequent trials.

Disrupting Eating Disorders

With eating disorders affecting an estimated 9% of the world's population, including nearly 29 million Americans, it's a significant market opportunity. However, traditional biotechs and pharmaceutical companies can claim minimal success at best in conquering eating disorders. When it comes to binge eating disorder (BED), a primary target of Tryp, Vyvance, an ADHD drug by Shire with an expanded indication approved in 2015, is the only drug on the market specific to the disease.

Tryp plans to have an IND application submitted to the FDA for a Phase 2a trial evaluating TRP-8802 in patients with BED and hypothalamic obesity. The University of Florida's Dr. Jennifer Miller is serving as the principal investigator in the trial. Miller is world-renowned for her expertise in eating disorders and has affirmed that patients face a dearth of treatment options to help with their afflictions.

Markets Reward Phase 2

Tryp is one of an elite group to reach Phase 2 research with a psychedelic drug compound, so initiating multiple Phase 2a trials this year represents a major milestone. Early-stage drug developers are typically valued based on advancing drug candidates towards commercialization since revenue and earnings are absent. With each completed phase in the FDA process, risk of failure is reduced, odds of an FDA approval are increased, and market value rises appropriately. When it comes to mid-stage studies, valuation have been shown to increase fourfold upon successfully completing Phase 2 clinical trials.

To date, seven public companies have initiated Phase 2 studies for a psychedelic-based therapy. The majority are targeting depression, which is not surprising given the library of anecdotal and clinical research supporting the potential to make an impact where conventional drugs have mostly failed. For those companies making the list, there is a wide range of market valuations, ranging from $85 million to $2.5 billion. As it looks to commence Phase 2 trials, Tryp has a market capitalization of approximately $31 million.

Depression, Addiction, Clinics and More

This has already been a big year for psychedelics, with no signs that momentum will begin to wane anytime soon given the uptick in research. In addition to Tryp, a small group of companies are distinguishing themselves as pioneers in the space.

Seelos Therapeutics Inc. (NASDAQ: SEEL) is a member of the Defiance Next Gen Altered Experience ETF, the first U.S.-listed Exchange Traded Fund focused on psychedelics. The company has a diverse pipeline that includes non-psychedelic assets but earned its spot in the ETF for its lead program of 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 in patients with major depressive disorder (MDD).

Awakn Life Sciences Corp. (NEO: AWKN) has a multiprong business strategy, including clinical operations and research into developing a pipeline of next-generation therapeutics to treat addiction with a near-term focus on ketamine, a medium-term focus on MDMA, and a long-term focus on Awakn's own developed drugs. This month, Awakn said it will undertake a program of clinical research designed to demonstrate the effectiveness for ketamine-assisted psychotherapy against multiple addictions, including alcohol use disorder (AUD) and gambling addiction.

Field Trip Health Ltd. (TSX: FTRP) (OTCQX: FTRPF) is known as a global leader in the development and delivery of psychedelic therapies. The company's Field Trip Discovery division develops psychedelic molecules and conducts advanced research on plant-based psychedelics, while the Field Trip Health division builds centers for psychedelic therapies opening across North America and Europe along with the digital and technological tools to facilitate scaling.

Small Pharma Inc. (TSX-Venture: DMT) is a neuropharmaceutical company focused on psychedelic-assisted N,N-dimethyltryptamine (DMT) therapies. Small Pharma is planning to initiate a Phase 2a trial to evaluate its SPL026 product for depression by the end of the year and has launched a training program to educate psychologists on the process required for the support and completion of Small Pharma's DMT-assisted therapy clinical trials.

Like any emerging market, psychedelic stocks have certainly had their ebbs and flows of attention and excitement. We are now beginning to see more separation among the field of psychedelic participants as speculation gives way to more fundamental analysis of the companies' drug development pipelines and the unique indications they are pursuing. And we are just scratching the surface with understanding the medical potential of psychedelic medicines for the millions of patients who need them most.

For more information about Tryp Therapeutics, please visit Tryp Therapeutics Inc.

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