Natural Drug Treatments Offer Promise, Potential as Savvy Drug Developers Recognize True Opportunities

NetworkNewsWire Editorial Coverage: Before government legislation brought the world of psychedelic drug compounds to a halt, promising research was being done in the space. As researchers and scientists took closer looks at substances such as psilocybin, ketamine, DMT (dimethyltryptamine), LSD (lysergic acid diethylamide) and more, the potential for the compounds appeared to be widespread and even life-changing for many who struggled with notoriously difficult diseases such as depression, addiction, PTSD and more. And then the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970, known as the Controlled Substance Act, took effect. For decades, the promise of these substances has remained ignored. However, with recent changes in legal guidelines and swings in public opinion, astute researchers — and companies — are showing renewed interest in the huge potential of a sector that, to many, feels much like the cannabis space a few years ago. Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) (Profile) is one of the savvy companies entering the public domain. Much like GW Pharmaceuticals Plc (NASDAQ: GWPH) — which was recently acquired by Jazz Pharmaceuticals (NASDAQ: JAZZ) in a billion-dollar transaction — pioneered the way in cannabis almost a decade ago, Tryp is leading the way with its focus on researching potential treatments for challenging disease through the use of naturally occurring compounds. Other companies are following suit. Through its Bioscience lab, Numinus Wellness (TSX.V: NUMI) was the first public company in Canada to receive a license to produce and extract psilocybin from mushrooms, and the first to complete a legal harvest of psilocybe mushrooms using this license. And Seelos Therapeutics Inc. (NASDAQ: SEEL) just announced positive data from its study evaluating ketamine as a treatment option for acute suicidal ideation and behavior ("ASIB") in patients with major depressive disorder ("MDD").

• Psychedelic therapeutics research market projected to reach $10.75 billion by 2027.
• Tryp following path to psychedelic success laid out by cannabis giant.
• Company’s primary indications are fibromyalgia, eating disorders using its proprietary psilocybin formulation.
• Diversified pipeline includes nonpsychedelic drugs such as Razoxane, which is in development for soft-tissue sarcomas.

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

Increased Interest, Escalating Evidence

In addition to federal regulations — or perhaps because of them — the social stigma attached to psychedelics in the last decades of the 20th century acted as a significant barrier to use of the compounds. While many were familiar with the street names of these much-disparaged substances, including magic mushrooms, ecstasy, Molly and LSD, few were familiar with what they actually were or what they did.

However, in recent years, tentative efforts have been made to study these natural treatment options. With initial studies showing promising results, increased interest has created a growing body of scientific clinical evidence that points to psychedelics perhaps being one of the greatest advancements in mental health and neuropsychiatric disease in decades.

The escalating evidence of the value of psychedelics being added to the array of medical options is following a path similar to that of medical cannabis. In fact, a recent ResearchandMarkets.com report projects 12.36% compound annual growth for the psychedelics drug market, with the market forecast to reach nearly $11 billion by 2027.

Led by a team of deeply experienced executives and advisors with decades of involvement in drug development, Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is forging the way forward as it focuses on taking natural compounds from early stage and advancing them through the rigors of clinical development to commercialization. This is where the comparison to GW Pharma begins, with the now cannabis giant being founded by experts in biotech and pharmaceutical development.

Faster, More Affordable Pipeline Development

The comparison doesn’t end there. GW started with a focus on pharmaceutical research of cannabinoids as potential treatments for various diseases, and that focus grew into an impressive pipeline. Tryp’s initial intent was to explore how psilocybin could be utilized as a potential medical treatment, and those efforts have grown into a strong pipeline with a focus on two active development programs: Psilocybin-for-Neuropsychiatric Disorders, or PFN(TM), for fibromyalgia, eating disorders and chronic pain conditions; and Razoxane (TRP-1001) for soft-tissue sarcomas. The lead drug in the PFN program is TRP-8802, a synthetic, oral psilocybin medication.

To advance its pipeline, Tryp is involved in a collaboration with University of Florida’s Jennifer Miller, MD. A professor of pediatrics and endocrinology at the university, Miller is leading Tryp’s phase 2 clinical trials, which are related to specific eating disorders. Treatments for these types of eating disorders haven’t evolved in many years, said Miller, and there is a heavy reliance on daily medications.

“All of the currently available approved obesity and eating disorder medications are daily medications,” she explained. “You stop taking them, you stop having the efficacy. Our hope with psilocybin [is that] once- or twice-a-year treatments will allow these neural networks to rewire themselves and provide a more chronic treatment, which doesn’t exist right now.”

In both clinical trials, Tryp is hoping for FDA 505(b)(2) approval, which allows it to bypass preclinical and phase I studies and move directly into phase 2 clinical trials. This streamlined approach allows drug developers to use work done by others to demonstrate the safety of a particular active ingredient. In this way, Tryp intends to advance its development programs more quickly and reduce costs so often required for successful drug development.

Orphan Drugs Bring Billion-Dollar Opportunities

Tryp is also eyeing the potential for orphan drug status in its pipeline, once again following in the footsteps of GW Pharma. In 2014, GW Pharma received orphan drug designation for Epidiolex(R), its product candidate that contained plant-derived cannabidiol ("CBD") targeted for use in treating children with Lennox-Gastaut syndrome ("LGS"); the company also received orphan drug designation in 2015 for cannabidiol ("CBD") for use in in treating newborn children with neonatal hypoxic-ischemic encephalopathy ("NHIE").

By definition, orphan indications are rare diseases with few treatment options that impact fewer than 200,000 persons in the country. Receiving an FDA orphan drug designation provides numerous incentives 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.

Tryp is pursuing the orphan drug pathway for its TRP-1001, an oral formulation of razoxane for the treatment of soft-tissue sarcoma. Soft-tissue sarcomas are rare tumors that account for only about 1% of all cancers in adults and 7% in children.

Unmatched Leadership Team

Tryp’s leadership team is unmatched. Led by Gregory McKee, who recently joined the company as CEO and executive chairman at Tryp, the team also includes Tryp co-founder and director James Kuo, MD, and president and chief science officer James Gilligan, PhD.

McKee brings 20-plus years 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). Kuo has extensive experience garnered from Pfizer, Discovery Labs, Myriad Genetics and as current chairman of ImmunoPrecise. Gilligan brings more than 30 years of life-sciences experience to Tryp after co-founding Unigene Laboratories and the Bracken Group.

And that’s just the tip of the leadership iceberg at Tryp. The entire Tryp C-suite, board and advisory team touts similar resumes. Key management execs have held top positions and leadership roles at companies such as Pfizer, QLT, ImmunoPrecise Antibodies and more. COO Tom D’Orazio has carefully guided two cancer drugs through the Health Canada approval process, while vice president of manufacturing Larry Norder oversaw the  chemistry aspects of early-stage R&D, preclinical and clinical developments for the blockbuster Naproxen.

One of the world’s foremost experts in administration of psychedelic compounds, Dr. Robin Carhart-Harris, recently joined Tryp’s Scientific Advisory Board (SAB). Other new board members include Dr. Joel Castellanos and Dr. William Schmidt, both leading experts in drug development for chronic pain.

Diverse Pathways Offer Options

Companies and individuals looking to invest in innovation in healthcare are finding possibilities in both diverse FDA pathways, such as FDA 505(b)(2) approval and orphan drug distinctions, as well as therapeutic psychedelics development.

GW Pharmaceuticals Plc (NASDAQ: GWPH) has established a global reputation as a pioneer in drug development, with its hugely successful development of plant-derived cannabinoid therapeutics. The company has become a leader in proven drug discovery and development processes, intellectual property portfolio, and regulatory and manufacturing expertise. In addition, GW Pharma has developed a deep pipeline of additional clinical-stage cannabinoid product candidates under development for both orphan and nonorphan indications with a particular focus on neurological conditions.

In what it called a “milestone” move, Jazz Pharmaceuticals (NASDAQ: JAZZ) earlier this month announced the completion of its acquisition of GW Pharmaceuticals PLC. "We are excited to welcome our GW colleagues to Jazz as we mark a transformative milestone in creating an innovative, high-growth, global biopharma leader in neuroscience with a worldwide commercial and operational footprint," said JAZZ chair and CEO Bruce Cozadd. "The addition of GW further diversifies our commercial portfolio and innovative pipeline with therapies that are complementary to our existing business. . . . We are fortunate to be combining two companies that share a passion for, and track record of, developing differentiated therapies that advance science and the care of patients with often-overlooked diseases.”

Numinus Wellness (TSX.V: NUMI) has created a first-mover advantage that allows the company to research and develop proprietary, standardized extraction methods, testing methods and product formulations for use in R&D partnerships, contract research services and clinical trials. The company also possesses a dealer's license from Health Canada to import, export, possess, test and distribute MDMA, psilocybin, psilocin, DMT and mescaline. Numinus also holds a cannabis testing license from Health Canada, allowing the company to provide third-party analytics and testing services for revenue generation.

Seelos Therapeutics (NASDAQ: SEEL) recently announced positive data from its proof-of-concept study of SLS-002 (intranasal racemic ketamine). The results included high response rates as well as rapid, robust and sustained reduction in suicidality by all three scales measuring suicidality. "There is no medication approved by any regulatory agency for the treatment of suicidal ideation and behavior in depression or in any mood disorder,” said David V. Sheehan, MD, in the announcement. “This recent early phase 2 Seelos open-label study data is a promising step towards achieving that goal. If replicated in a larger placebo-controlled study, these findings would be a historic contribution to the treatment of suicidality."

Clearly the psychedelic wave is growing. With legislation changing and social stigma easing, the once disgraced space is gaining credibility and respectability — and even more important, bringing potential and promise that change is on the healthcare horizon.

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

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