NetworkNewsWire Editorial Coverage: In May 2013, GW Pharma listed on Nasdaq, selling 3.5 million shares at $8.90 each to investors betting that GW was charting a profitable course as a biotech developing new drugs from cannabis-derived compounds. Legal cannabis was only beginning to gain momentum at that time, and while countless companies saturated the market as would-be growers, distributors, etc., GW was taking a more difficult route of drug development with much greater upside if successful. The strategy paid off as the company received FDA approval for the first-ever cannabis-based drug in June 2018. There are some notable similarities between the evolution of the legal cannabis market a decade ago and the current status of psychedelics, longtime illicit drugs that are now being evaluated for their therapeutic potential by a handful of upstart companies. San Diego-based Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile) stands out, not only for its still-small valuation but also because it has a successful management team that, much like GW, is charting its own course in the space. Major investors have not been shy about speculating that biotech is going to produce some psychedelic-derived blockbusters, as evidenced by the attention given to COMPASS Pathways Plc (NASDAQ: CMPS), Mind Medicine (“MindMed”) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ) and newly public ATAI Life Sciences N.V. (NASDAQ: ATAI), any one of which could do for psychedelics what GW Pharmaceuticals (NASDAQ: GWPH) did for cannabis before being acquired in February by Jazz Pharmaceuticals plc (NASDAQ: JAZZ) for $7.2 billion.
- Venture capital has been pouring into psychedelics, rising from under $100 million in investments in 2019 to $346 million in 2020 and already $329 million in 2021.
- Jazz Pharmaceuticals paying $7.2 billion for cannabis drug maker GW Pharma has investors looking at early-stage psychedelic companies.
- Tryp Therapeutics is one of only a handful of companies moving into Phase 2 clinical trials with a psychedelic compound.
- Tryp has a seasoned management team, board of directors and scientific advisory board with experience throughout the drug development process.
Value Resides in Drug Development
A traditional biotech such as Jazz acquiring GW Pharma was a bona fide inflection point for the cannabis industry, as simultaneously a stamp of approval was put on both cannabis-derived compounds and high valuations for drug-development companies working with Schedule I drugs. GW was a true trendsetter with its Epidiolex (cannabidiol) for controlling seizures in rare forms of epilepsy. The new drug generated more than $500 million in sales in 2020 and is expected to top $1 billion in the near future.
The brilliance of GW is that it used decades of anecdotal evidence about cannabis to synthesize a natural cannabinoid for a large market opportunity where conventional drugs have fallen short. Unfortunately, President Richard Nixon signing the Controlled Substance Act in 1970 put a damper on clinical research of not only marijuana but psychedelic drugs as well, including psilocybin (a compound of magic mushrooms), MDMA (known molly or ecstacy), lysergic acid diethylamide (LSD or acid) and N-Dimethyltryptamine (DMT), which all were lumped in as Schedule I drugs deemed to have zero medical use.
A willingness from the FDA to evaluate cannabis-derived compounds for their clinical merit has led to a resurgence in clinical research proving this categorization wrong, not to mention lending to a shift in removing the negative stigma of cannabis in favor of what could be transformational medical advancements for areas of great unmet need. A similar trend is underway with psychedelics, which are already benefiting from the path carved by cannabis drug development pioneers such as GW.
This month’s IPO of atai Life shines a spotlight on the growing interest in the drug-development side of the space. The company raised more than $200 million through a U.S. initial public offering comprised of 15 million common shares priced at $15 and targeting a valuation of approximately $2.3 billion.
Big Pharma Comes to Psychedelics
Many companies are angling to capitalize on the emergence of psychedelics for therapeutic indications, but only a select few pharmaceutical companies are entering Phase 2a clinical trials, including Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF). Tryp’s pipeline is comprised of its Psilocybin-for-Neuropsychiatric Disorders, or PFN, program that includes TRP-8802, the initial oral formulation of psilocybin for Tryp’s Phase 2a clinical trials, and TRP-8803, a proprietary formulation with novel method of administration planned to be used for Phase 2a trials.
With world-class management and advisors, Tryp is advancing its PFN program into Phase 2a clinical studies, a derisking factor not seen in most peers. Furthermore, Tryp is differentiated by evaluating indications outside the limited mental health conditions that others in the space are pursuing.
Tryp’s leadership is one that is fitting for a major pharmaceutical company. The executive team has degrees from some of the nation’s top institutions including University of Pennsylvania’s Wharton School, Loyola, Univeristy of Connecticutt, Notre Dame, BYU and Vanderbilt to provide a sampling. Before making their foray into psychedelics with Tryp, management experience has come from careers founding or holding leadership positions at the likes of Genzyme, Unigene, Tarsa Therapeutics, Dow Chemical, ImmunoPrecise, ConSynance, DelMar Pharmaceuticals and many more.
The company’s board of directors and advisory team mirror the same type of credentials. In aggregate, the company has decades of experience in drug development from the bench to commercialization and capital markets; its scientific advisory board is led by Robin Carhart-Harris, PhD, and has expertise in everything from pscyhedelics and the initial target indications of pain management and eating disorders. Leveraging the network of the team, Tryp has partnered with Albany Molecular Research for manufacturing services for synthetic psilocybin and Alcami for analytical methods and final formulations in preparation for clinical trials.
Eating Disorders and Chronic Pain on Tap
Tryp is pursuing two indications representing large opportunities that have proven mostly elusive to conventional drugs. Eating disorders have been particularly difficult, even against the backdrop of 9% of the global population (a figure consistent in the United States) developing an eating disorder at some point in their lives. Tryp has partnered with the University of Florida to conduct a Phase 2a trial of TRP-8802 for patients suffering from rare and other overeating disorders where there are extremely limited or no treatment options available today. Jennifer Miller, MD, a professor in the division of pediatric endocrinology at University of Florida, is serving as the trial’s principal investigator.
Expectations are that patients with binge eating and hypothalamic obesity will respond favorably to the neuroplasticity effects of TRP-8802 in combination with psychotherapy. These types of eating disorders have limited treatment options, and Tryp has partnered with Fluence to provide design and training for the psychotherapeutic portion of its clinical studies.
Pain Market Ripe for Disruption
Keeping with its theme akin to the GW approach of targeting difficult or unattended diseases and disorders with a fully synthesized regulated compound, Tryp is also developing TRP-8802 for chronic pain conditions, including fibromyalgia, phantom limb pain and complex regional pain syndrome. These are maladies that affect millions of people as part of a global chronic pain market forecast to grow 6.5% annually to reach $151.7 billion in 2030. The fibromyalgia treatment market alone is expected to exceed $3.6 billion by 2026.
Perhaps no other market is ripe for innovation like that of chronic pain, where opioids and other drugs with well-known negative side effects and addictive properties dominate. A safe and effective alternative has blockbuster potential. Clinical trials are being planned to evaluate if TRP-8802 can modulate chronic pain through action in the descending pain inhibitory pathway and increased neuroplasticity. The chronic pain indications that Tryp has selected share a common characteristic of having pain signals that originate from the central nervous system rather than from localized trauma.
Follow the Money to Drug Development
It’s encouraging to see the large amount of capital being deployed to support innovation in drug development for compounds derived from cannabis and psychedelics. According to CB Insights, venture capital investment has been growing dramatically in the last few years, rising from under $100 million in 2019 to $346 million in 2020 and already $329 million in 2021. Following the money shows that a large portion of investment capital is being directed to companies pursuing regulated drug development of these compounds for medical indications.
COMPASS Pathways Plc (NASDAQ: CMPS), a U.K.-based company with a patented synthetic version of psilocybin for use in treatment-resistant depression, is indicative of investors’ appetite. COMPASS is advancing its psilocybin therapy program under an FDA Breakthrough Therapy designation awarded in 2018 and has recently published additional information on the strong safety profile of its treatment. The company completed its initial public offering in September, selling 7.5 million shares priced at $17 each, above the expected range of $14-$16 for a market cap nearing $1 billion. By mid-December shares of CMPS were at a record high of $61.69.
Mind Medicine (“MindMed”) Inc. (NASDAQ: MNMD) (NEO: MMED) (DE: MMQ), which listed on Nasdaq in April, is taking a multidisciplinary approach to psychedelics. The company is extremely active in its development efforts. For instance, in recent weeks, the New York-based company has added multiple team members, received approval from the local Swiss ethics committee for a mescaline study and completed its pre-IND meeting with the FDA to select generalized anxiety disorder as the initial indication for its upcoming Phase 2b trial for its LSD therapy.
ATAI Life Sciences N.V. (NASDAQ: ATAI) has been the talk of the psychedelics space lately. The German company, which counts PayPal founder Peter Thiel as one of its biggest investors, completed its IPO this month, raising $225 million by pricing shares at the high end of the range at $15 each. ATAI is different than others insomuch that it is effectively a holding company that invests in companies developing mental health treatments, currently overseeing 10 therapeutic programs, including five using different types of psychedelic chemistries.
Jazz Pharmaceuticals plc (NASDAQ: JAZZ) is a prime example of commitment to the emerging cannabis drug-development market, recently paying $7.2 billion in cash and stock for GW Pharma. With U.S. sales of Epidiolex topping $500 million last year and the recent launch in Europe under the brand name Epidyolex, management is expecting the franchise to cross $1 billion in annual sales in the near term. Moreover, Jazz is conducting research of Epidiolex for additional indications, which will not only add to corporate coffers should they reach commercialization, it will also lend further validation to the legitimacy of cannabis-derived compounds to further strengthen the chemistry’s reputation as a medicine.
The aforementioned companies are instrumental to a growing body of research proving the therapeutic benefits of psychedelics and other Schedule 1 compounds, which is a welcome development to millions of patients who are currenty suffering from diseases with limited and ineffective treatment options.
For more information about Tryp Therapeutics, please visit Tryp Therapeutics Inc.
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