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:
Sarcomas are rare tumors derived from connective tissues in the body 1
Sarcomas can occur anywhere in the body and have widely variable clinical courses ranging from indolent to highly aggressive 1
In most cases, it is not clear what causes sarcoma, but family history and radiation exposure may increase risk 2
In 2018, estimated 13,000 new cases of soft tissue sarcoma and over 5,000 deaths in the US alone 3
Surgery is still the most common treatment as it remains the only means of curing the disease 4 radiation and chemotherapy also part of treatment paradigm
Development Path: Re-establish Phase 2 activity in soft tissue sarcomas after which will endeavor to monetize the asset.
Multicenter Phase 2 clinical study conducted in Austria by the Austrian Society of Radio-Oncology in 2009
When used in conjunction with radiation therapy or other agents the combination tended to work well together and inhibit metastatic tumor activities (the recurrence of additional tumors elsewhere in the body)
Tryp believes that existing clinical data regarding razoxane may allow TRP-1001 to be studied in a Phase 2 trial without the need for extensive preclinical or Phase 1 trials.
4. https://www.cancertherapyadvisor.com/home/cancer-topics/sarcoma/lartruvo- olaratumab-offers-new-promise-for-patients-with-soft-tissue-sarcoma/
Oncology is the leading therapeutic category and represented 25% of all drug sales in 2018 - approximately US $151 billion, estimated to grow to 30% of all drug sales in 2024 - approximately US $200 billion1
Oncology is one of the most active therapeutic areas in terms of licensing and M&A transactions 2 and 2019 saw several high-profile deals:
1. Cowen Therapeutic Categories Outlook, September 2019
2. Biopharma dealmakers, December 2019
Serious and complex genetic disorder caused by the lack of expression of several genes on chromosome 15
HYPERPHAGIA (unrelenting hunger) is the hallmark symptom of PWS that starts at 5-8 years old and lasts until death
Currently, there is no effective or approved treatment for hyperphagia and abnormal eating behaviors associated with PWS
Growth hormone is used for improvement in height, cognition and body composition, but has no effect on appetite and over-eating 2
PWS market has been witnessing considerable growth over the past few years due to increasing number of diagnosed patients
According to Azoth Analytics research report,
The PWS therapeutics market is projected to display a ROBUST GROWTH represented by a CAGR of 4.6% during 2019 – 2024