Tryp Therapeutics is a pharmaceutical company looking to develop compounds for the treatment of rare diseases. Tryp’s psilocybin-for-neuropsychiatric disorders, or PFN program, focuses on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders.
Tryp’s lead drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain
syndrome estimated to affect more than five million people in the United States. It is also evaluating additional indications for its PFN program, including hyperphagia in Prader-Willi Syndrome (“PWS”) and other neuropsychiatric-based chronic pain conditions and eating disorders.
The company listed on the Canadian Securities Exchange on December 18, 2020 under the ticker “TRYP”. The stock saw a good response from the public on its debut. Including its over-allotment option, a total of 20,010,000 Units were sold at a price of C$0.25 per Unit for aggregate gross proceeds of ~C$5 million.
Tryp intends to use a portion of the funds for R&D development purposes as well as IND-enabling activities. The company will in all likelihood outsource these activities to third-party organizations.
Major components of the company’s research and development programs include formulation and manufacturing process development; certain preliminary manufacturing activities; development of clinical trial protocols; and preparation for Type B meetings with the FDA.
Active Development Programs at Tryp
Tryp currently has two active development programs:
By capitalizing on the poly-pharmacology of its PFN program, Tryp believes it can create orally-delivered therapies with a distinct advantage over other options currently available in the market.
As stated above, the initial PFN program candidate is TRP-8802. The initial indication for TRP-8802 is fibromyalgia, a condition characterized by pain that is chronic and
widespread. Hyperphagia in the orphan disease Prader-Willi Syndrome is currently under evaluation as a second indication for TRP-8802.
In August 2020, it entered into an agreement with AMRI pursuant to which AMRI will provide research, development and cGMP manufacturing services for the development of a form of synthetic psilocybin that will form the basis of its PFN Program.
Currently, there are no approved products to address PWS-associated hyperphagia and behaviors. Though there are a number of therapeutic products at various stages of clinical development for the treatment of PWS, including for hyperphagia, several development programs have failed to meet the clinical endpoints of their Phase II and Phase III clinical trials with some programs being terminated.
The only approved product for PWS is the injectable growth hormone somatropin, which is approved only for growth failure in pediatric PWS patients. It does not address PWS-associated hyperphagia and behaviors.
Soft Tissue Sarcoma Program
TRYP is also evaluating TRP-1001, an oral formulation of razoxane, for the treatment of soft tissue sarcoma (“STS”). TRYP will initially focus on TRP-1001 in combination with a microtubule target agent from the vinca alkaloid class of compounds and radiation therapy.
STS patients are typically treated with surgery, followed by radiation therapy and/or
chemotherapy. Chemotherapy is a cancer treatment that uses drugs to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
While the FDA has granted a small number of approvals for new STS drugs in recent
years, there remains a significant unmet medical need for new STS treatments.
Tryp Pipeline Summary
Tryp has selected specific drug candidates and diseases that it believes offer the greatest opportunity for therapeutic efficacy and commercial success. It seeks to treat diseases with unmet needs where competition is limited. It intends to design clinical development programs that have clearly defined and achievable endpoints, in order to increase its chance of commercial success.
Patent applications for the use of psilocybin for the treatment of fibromyalgia and razoxane for the treatment of soft tissue sarcomas were filed in 2019 and 2020, respectively.
Below we list out the other life science companies which offer treatments for the indications being targetted by TRYP.
TRP-8802 for Fibromyalgia
TRP-8802 for PWS-related Hyperphagia
TRP-1001 for STS
Market Outlook for Tryp Therapeutics
The market for Fibromyalgia treatment is expected to surpass $4.6bn by 2026. Many approved fibromyalgia therapies have unclear or partially understood mechanisms of action. A lot of them may involve multiple potential mechanisms and targets, leading to inconsistent responses and side effects.
Despite the existence of approved treatment options, approximately 30 percent of
patients diagnosed with fibromyalgia become chronic opioid consumers. There is no evidence for opioids’ effectiveness in treating fibromyalgia, though they do pose a significant risk of addiction and overdose. This provides Tryp with a large addressable market going forward.
The National Cancer Institute estimates that in 2017 there were ~150,000 people in the U.S. diagnosed with STS. Since 2015 the FDA has approved a number of new drugs for the treatment of certain sub-types of STS. However, some of these were withdrawn from the market due to failure to show improvement over placebo in a post-approval confirmatory clinical trial.
TRP-1001 represents an opportunity to improve upon both the safety and clinical benefit profiles of approved agents in STS, which to date have demonstrated poor toxicity and produced a limited impact on patient survival. Furthermore, Tryp intends to leverage existing third-party preclinical and clinical data to expedite their drug development programs. This is permitted under the FDA’s Section 505(b)(2) pathway, which permits the submission of New Drug Applications (NDAs) that rely in part on third-party investigations. This could help Tryp expedite the drug development process by potentially decreasing the amount of preclinical and clinical data needed in order to obtain FDA approval.