Tryp intends to seek approval from FDA to proceed directly into a Phase 2 clinical trial based on existing preclinical and clinical data for the active pharmaceutical ingredients in TRP-8802 and TRP-8803
TRYP's Psilocybin-for-Neuropsychiatric Disorders (PFN™ ) Program
Tryp Therapeutics is focused on identifying compounds with well characterized safety and activity profiles that have potential utility in orphan diseases and other diseases with high unmet medical needs. Tryp currently has two active development programs:
Develop: Tryp intends to combine FDA’s 505b2 regulatory pathway with available third-party preclinical and clinical data to shorten the timelines and lower the cost of its development programs.
Protect: Tryp will 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 its drug candidates during and around their Phase 2 stage of development.
Through our PFN™ program, we are focused on developing orally-delivered drug therapies for certain neuropsychiatric disorders that have distinct advantages over other drugs that are currently in the market or are in development. These advantages include:
The lead candidate in our PFN™ Program is TRP-8802, an orally-delivered formulation base on the development of Tryp's synthetic psilocybin.
Chronic and debilitating CNS / neurobiological disorder characterized by:
Believed to be a neurosensory disorder characterized in part by abnormalities in pain processing by the central nervous system.
Causes significant impairment in all areas of life 2
The three drugs with FDA approval for the treatment of fibromyalgia are Pregabalin (Lyrica®), Duloxetine (Cymbalta®*) and Milnacipran (Savella®)
Currently-approved medications may have side effects that limit long-term use 3 are only effective for some symptoms, but do not cover the full burden of the disease
Substantial off-label use of narcotic painkillers and prescription sleep aids 4
1. Phillips K & Clauw DJ, Best PractRes Clin Rheumatol 2011; 25:141
2. Schaefer et al., Pain Pract, 2015
3. Nueschet al, Ann Rheum Dis 2013;72:955-62
4. Patient Trends: Fibromyalgia”, Decision Resources, 2011
Fewer than half of those treated for fibromyalgia receive complete relief from the three FDA-approved drugs
The disease inflicts substantial strain on the healthcare system:
High rates of discontinuation, switching and augmentation: