Tryp Therapeutics Inc. (CSE: TRYP) (OTCQB: TRYPF) is a pharmaceutical company focused on developing clinical-stage compounds for diseases with high unmet medical needs through accelerated regulatory pathways.
The company was founded in 2019 and is headquartered in San Diego, California.
Innovative Drug Pipeline
Tryp’s current focus is on advancing its two drug development platforms: its Psilocybin-for-Neuropsychiatric Disorders (PFN™) program targeting fibromyalgia, eating disorders and chronic pain conditions; and razoxane for soft tissue sarcomas. The company intends to explore opportunities to monetize these platforms after generating Phase 2b clinical data.
The company’s development plans cover three strategic initiatives:
- 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.
- Monetize: Tryp intends to seek out licensing, acquisition and co-development opportunities for drug candidates following their Phase 2 stages of development.
Through its PFN™ program, the company is focused on developing psilocybin-based drug therapies for certain neuropsychiatric disorders that have distinct advantages over other drugs currently on the market or in development. These advantages include:
- Increased efficacy
- Natural blood-brain barrier penetration
- Enhanced safety and toxicity profiles
- Reduced risk of abuse
- Reduced risk of addiction
Tryp’s PFN™ program features its lead drug candidate, TRP-8802. The company’s initial indication for TRP-8802 is fibromyalgia.
Fibromyalgia is believed to be a neurosensory disorder characterized in part by abnormalities in pain processing by the central nervous system. The three drugs with FDA approval for the treatment of fibromyalgia are Pregabalin (Lyrica®), Duloxetine (Cymbalta®) and Milnacipran (Savella®), which are only effective for a portion of patients suffering from the condition.
Tryp plans to seek FDA approval to proceed directly to Phase 2 clinical trials evaluating TRP-8802 as a treatment for fibromyalgia based on existing preclinical and clinical data for the active pharmaceutical ingredients in TRP-8802.
Tryp’s pipeline of indications for TRP-8802 also includes eating disorders and certain forms of chronic pain. The company expects to initiate Phase 2a clinical trials in these areas in 2021.
Tryp recently partnered with Albany Molecular Research Inc. (“AMRI”) for the manufacture of the company’s synthetic psilocybin using proprietary methods. AMRI has initiated the process of manufacturing a 200g non-GMP demonstration batch of psilocybin and will produce a batch of GMP psilocybin in mid-2021. As the holder of the Drug Master File, Tryp expects to be the only U.S.-based manufacturer of synthetic psilocybin in the industry.
Tryp’s second drug candidate, TRP-1001 (razoxane), is being developed as a treatment for soft tissue sarcomas and has been evaluated in multiple Phase 2 clinical trials conducted by clinicians unaffiliated with Tryp. The company believes that existing clinical data regarding razoxane will likely allow TRP-1001 to be studied in a Phase 2 trial without the need for extensive preclinical or Phase 1 trials.
Sarcomas are rare tumors that are derived from connective tissues in the body and comprise 7% of all cancers in children. In 2018, an estimated 13,000 new cases of soft tissue sarcoma were diagnosed, with the tumors resulting in over 5,000 deaths during that year in the United States alone (https://ibn.fm/nWOGq).
With its drug development programs targeting multiple indications, Tryp is well positioned to capitalize on growth opportunities spanning a range of therapeutic markets. The global oncology drugs market, in particular, represents a sizable opportunity.
In 2018, oncology indications accounted for 25% of all drug sales, representing approximately $151 billion in market revenues. By 2024, spending on oncology-targeted therapeutics is expected to top $200 billion and account for roughly 30% of total drug sales, according to a study by Cowen Equity Research (https://ibn.fm/9iZhM).
Valued at $764 million in 2020, the global fibromyalgia treatment market presents unique opportunities for development due to the limited number of approved therapies. With treatment trending upward, the market is expected to grow at a CAGR of 9.2% and reach $1.4 billion in value by 2027 (https://ibn.fm/G66e7).
Greg McKee is the Chairman and CEO of Tryp Therapeutics. He has more than 20 years of life sciences management and venture investment experience that he brings to the company. Before taking his role at Tryp, he was the founder of Torrent Ventures, an early-stage digital health and medical technology venture fund. Mr. McKee also served as the CEO of CONNECT, the largest Southern California start-up accelerator. Before this, he was the chairman, president and CEO of then publicly traded Nventa Biopharmaceuticals, which successfully merged with Akela Pharma. Mr. McKee earned a B.A. in Economics from the University of Washington, an M.A. in International Studies from The Joseph H. Lauder Institute, and an MBA from the Wharton School at the University of Pennsylvania. He has been a member of the Young President’s Organization (YPO) since 2006.
James Gilligan, Ph.D., is the company’s President and Chief Science Officer. He has over 35 years of experience in the life sciences industry, including research and development, clinical development, international regulatory affairs and manufacturing. Before joining Tryp, Dr. Gilligan was the Co-Founder and Managing Partner of The Bracken Group, a life sciences consulting firm. He was also the Co-Founder of Unigene Laboratories, which develops technology for the recombinant manufacture of peptide hormones. Dr. Gilligan received his Ph.D. in Pharmacology from the University of Connecticut and a MSIB from Seton Hall University. He continued his post-graduate education at the Roche Institute of Molecular Biology.
Tom D’Orazio is the Chief Operating Officer of Tryp Therapeutics. He has extensive experience in leading the development and commercialization of vaccines, drugs, radiopharmaceuticals and biologics. His prior leadership experience has been in commercial planning, marketing, partnership and business development roles. He was formerly the CEO of ImmunoPrecise Antibodies Ltd. (NASDAQ: IPA), where he led the transition from a private company to a public one. He co-founded and served as CEO of Superna Life Sciences, a specialty-pharma company focusing on niche drugs for cancer patients in Canada. Mr. D’Orazio has an MBA from Vanderbilt University with a primary focus in both finance and marketing and a B.Sc. in chemistry from Loyola University of Chicago.
Luke Hayes is the company’s Chief Financial Officer. He has played an active role in the life science industry for over 20 years with technology transfer, venture capital and finance experience. His career started with business development for Dow Chemical (NYSE: DOW), with responsibility for pharmaceutical customers such as Eli Lilly and AbbVie. Mr. Hayes has spent more than a decade doing venture capital investing while supporting companies as a director and advisor. He earned a B.S. in Chemical Engineering from Brigham Young University and an MBA from the UCLA Anderson School of Management.
- Tryp Therapeutics is a pharmaceutical company with a focus on developing clinical-stage compounds for diseases with high unmet medical needs through accelerated regulatory pathways.
- The company currently has two drug candidates in development: TRP-8802 (targeting fibromyalgia, eating disorders and chronic pain conditions); and TRP-1001 (targeting soft tissue sarcomas).
- Through its PFN™ program, the company is focused on developing psilocybin-based drug therapies for certain neuropsychiatric disorders that offer increased efficacy and reduced risk of abuse or addiction.
- The company’s management team has decades of experience in the life sciences industry, including the pharmaceutical and biotechnology markets.
- Oncology therapeutics are expected to account for roughly 30% of all drug sales by 2024, representing a total market valued at approximately $200 billion.