Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF)

Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is leading the next wave of psychedelic drug development beyond mental health with its focus on psilocybin-based treatments for chronic pain and other indications. The company was founded in 2019 and is headquartered in San Diego, California.

Innovative Drug Pipeline

Tryp's Psilocybin-for-Neuropsychiatric Disorders (PFN™) program is focused on the development of synthetic psilocybin for chronic pain and other indications.

The company has announced plans to initiate four upcoming Phase 2a clinical trials in fibromyalgia, phantom limb pain, complex regional pain syndrome (CRPS), and certain overeating disorders (binge eating disorder and hypothalamic obesity). At least two of the Phase 2a studies are expected to begin enrolling patients in 2021.

The company's development plans cover three strategic initiatives:

• Innovate: Tryp is using its unique drug products to pursue chronic pain and other indications that most other psychedelic companies are not through collaborations with leading academic institutions such as the University of Michigan, the University of Florida, and others.
• Develop: Tryp intends to utilize the FDA's 505(b)(2) regulatory pathway with available third-party preclinical data to shorten the timelines and lower the cost of its development programs.
• Protect: Tryp plans to utilize regulatory exclusivity, patents, trade secrets and proprietary know-how to protect the commercial lifespan of its drug candidates.

Addressing Significant Patient Needs

Through its PFN™ program, the company is focused on developing psilocybin-based drug therapies for certain neuropsychiatric disorders that are expected to be more effective and to have fewer side effects than many available treatments on the market.

Tryp's PFN™ program features its initial drug candidate, TRP-8802, a synthetic psilocybin capsule that will be used for the company's open-label Phase 2a clinical trials. The company is also developing a proprietary drug product, TRP-8803, that utilizes a novel formulation and route of administration to improve the patient experience. TRP-8803 will be used in Tryp's Phase 2b studies and beyond. Importantly, Tryp has already secured an exclusive supply of its drug products through its partnerships with Curia and Alcami.

Tryp aims to address the significant and unmet needs of patients:

Fibromyalgia

• It is estimated that more than 4 million patients in the U.S. have been diagnosed with fibromyalgia.
• Existing treatments are ineffective for many patients and have significant side effects; only 10% of patients continue with approved treatment methods after one year.
• Nearly 30% of fibromyalgia patients are so desperate for treatment options that they are using opioids to address the symptoms of the disease – carrying significant addiction and overdose risks.

Phantom Limb Pain

• Phantom limb pain is estimated to have been diagnosed for more than 1 million patients in the United States.
• The condition is highly common for amputees, with more than 60% of them experiencing phantom limb pain.
• Existing treatment methods, such as mirror box therapy and others, are ineffective for many patients, creating a significant need for alternative approaches.

Complex Regional Pain Syndrome (CRPS)

• CRPS results from a misfiring of pain signals in the brain after injury, surgery, stroke, or heart attack. The brain is trained to generate pain signals during the trauma, but CRPS patients continue to feel pain that originates in the brain long after the other parts of the body have fully healed.
• It is estimated that nearly 100,000 patients in the U.S. have been diagnosed with phantom limb pain, and treatments focus on the symptoms rather that the source of the pain.

Binge Eating Disorder

• Binge eating disorder is a manifestation of addictive behaviors toward food that can be difficult for patients to break.
• Up to 3.5% of females and 2.0% of males are expected to develop binge eating disorder at some point in their lives, and many patients seeking assistance with weight loss exhibit signs of binge eating disorder.

Hypothalamic Obesity

• Hypothalamic obesity refers to obesity that is caused by damage to the hypothalamus, which makes hormones that control hunger.
• Hypothalamic obesity is a rare disease that is estimated to affect less than 5,000 patients in the U.S., but it has no available treatment options and dominates the day-to-day lives of patients and their families in significant ways.

Market Outlook

With its drug development programs targeting multiple indications, Tryp is well positioned to capitalize on growth opportunities spanning a range of therapeutic markets.

The commercial potential for Tryp's programs is significant given the high number of patients in the United States and around the world that have been diagnosed with the diseases that the company is pursuing.

Management Team

James Gilligan, Ph.D., is the company's President and Chief Scientific Officer. He was a co-founder of Unigene Laboratories, where he served in a variety of executive leadership positions for nearly 30 years. He subsequently co-founded and served as Chief Scientific Officer of Tarsa Therapeutics and as co-founder and Managing Partner at The Bracken Group, a life science consulting firm. Dr. Gilligan earned a BS in Biology from Bates College, an MBA from Seton Hall University, and a PhD in Pharmacology from the University of Connecticut. He played basketball at Bates College and continued his post-graduate education at the Roche Institute of Molecular Biology.

Robin Carhart-Harris, Ph.D., serves as the Chairman of the Scientific Advisory Board for Tryp Therapeutics. Dr. Carhart-Harris is the Ralph Metzner Distinguished Professor in Neurology and Psychiatry at the University of California, San Francisco. He is also the Director of the Psychedelics Division within the translational neuroscience Centre, Neuroscape, at UCSF. Dr. Carhart-Harris founded the Centre for Psychedelic Research at Imperial College London in April 2019, the first of its kind. He has designed human brain imaging studies with LSD, psilocybin, MDMA and DMT; a clinical trial of psilocybin for treatment-resistant depression; a double-blind randomized controlled trial comparing psilocybin with the SSRI, escitalopram, for depression that was published in the New England Journal of Medicine; and a multimodal imaging study in first time users of psilocybin. Dr. Carhart-Harris earned a BSc in Applied Psychology and Computing from Bournemouth University, an MA in Psychoanalysis and Contemporary Science from Brunel University, and a PhD in Psychopharmacology from the University of Bristol. He has published over 100 scientific papers and in 2021 was listed in Time Magazine's "100 Next," a list of 100 rising stars shaping the future.