Tryp will look to partner / monetize programs with Phase 2 clinical data

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:

• Psilocybin-for-Neuropsychiatric Disorders, which we call our PFN™ Program.
  • Our lead PFN™ Program candidate is TRP-8802.
  • Our initial indication for TRP-8802 is fibromyalgia.

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:

• Increased efficacy;
• Natural blood-brain barrier penetration;
• Enhanced safety and toxicity profiles;
• Reduced risk of abuse; and
• Reduced risk of addiction.

The lead candidate in our PFN™ Program is TRP-8802, an orally-delivered formulation base on the development of Tryp's synthetic psilocybin. 

Overview

Chronic and debilitating CNS / neurobiological disorder characterized by:

• Chronic widespread pain
• Fatigue
• Non-restorative / disrupted sleep
• Depressions
• Diminished cognition ¹

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

• Lower levels of health-related quality of life – reduced daily functioning
• Interference with work (loss of productivity, disability)

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

Market Opportunity

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:

• Average patient has 20 PHYSICIAN OFFICE VISITS PER YEAR ¹
• Annual direct medical costs are TWICE those of non-fibromyalgia individuals ²

High rates of discontinuation, switching and augmentation:

• Attempts to treat multiple symptoms and/or avoid intolerable side effects
• Average of 2-3 MEDICATIONS USED SIMULTANEOUSLY ³
• Typical patient has tried SIX DIFFERENT MEDICATIONS ⁴
• Medication-related side effects may be similar to fibromyalgia symptoms