PFN Program
Tryp Therapeutics (TRYP.C) is a Kelowna-based psychedelics company looking to improve the lives of those with fibromyalgia, hyperphagia, and eating disorders.
In the company’s young life so far it has created a drug development program & pipeline plan, grabbed research partnerships, and raised some dough to name a few things. Tryp is not a giant like Compass Pathways (CMPS.Q) or MindMed (MMED.Q), but they know who they are and aren’t trying to show off.
Their plan for targeting ailments like fibromyalgia differentiates them from several other psychedelics companies focused on depression, anxiety, and PTSD to name a few. While these issues and their effects have drastically increased throughout the pandemic, there is still room for other less talked about issues like the ones Tryp is going after.
The company’s drug development program centers around psilocybin for neuropsychiatric disorders (PFN). Their PFN program is focused on using synthetic psilocybin for the treatment of certain neuropsychiatric-based disorders. Tryp’s lead PFN drug candidate is TRP-8802, an oral dosage form of psilocybin for the treatment of fibromyalgia.
Two drugs, Cymbalta and Lyrica, developed by Eli Lilly (LLY.N) and Pfizer (PFE.N), are widely used for chronic pain conditions like fibromyalgia. Cymbalta, originally developed as an antidepressant has been wildly successful, topping out at 5 billion USD in sales per year. But despite these treatment options, there are holes in the current offerings. For example, according to researchers at Mayo Clinic, opioid use is reported in approximately 30% of fibromyalgia patients, risking addiction and overdose.
Fibromyalgia
As the opioid crisis continues to sweep across North America, it makes sense for companies to seek these alternative therapies. The death toll continues to climb and the only way out will likely be new innovations by emerging biotech companies. The fat cats have done well with the system as it is, which means it’s up for disruption.
Fibromyalgia is a chronic pain syndrome that can be considered a neurosensory disorder characterized in part by abnormalities in pain processing by the central nervous system. Patients suffer from widespread pain, stiffness, fatigue, disrupted and unrefreshing sleep, and cognitive difficulties. It affects more than 5 million people in the United States.
Tryp believes some of the benefits of their PFN™ program include:
• increased efficacy
• oral versus intravenous or subcutaneous dosing
• compliance-favorable dosing regimens
• natural blood-brain barrier penetration
• enhanced safety and toxicity profiles
• reduced risk of abuse
• reduced risk of addiction
Tryp intends on utilizing its program to build out a pipeline of therapeutics for additional related disease targets. For example, hyperphagia is currently under evaluation as a second indication for TRP-8802.
Tryp is also developing TRP-1001, an oral formulation of razoxane for the treatment of soft tissue sarcoma. Soft tissue sarcomas are a rare and diverse group of tumors that account for about 1% of all cancers in adults and 7% in children. Based on the prevalence of soft tissue sarcomas in the United States, Tryp believes it is a rare disease and that TRP-1001 should qualify for orphan drug status.
Logistics & research
The company is pre-revenue, with total assets as of $7.5 million CAD, including $6.7 million CAD in cash after a $2M CAD financing in February.
Their manufacturing strategy is to contract with third parties to manufacture their APIs and finished drug products. Tryp is looking to file patent applications in the United States and other regions of the world for their drug development program. In August 2020 Tryp entered into an agreement with AMRI – an R&D/ manufacturing organization for high potency compounds. AMRI will provide research, development, and cGMP manufacturing services for the synthetic psilocybin API that Tryp will use for their PFN program.
Their patent strategy includes pursuing protection for any proprietary forms of synthetic psilocybin that they may develop; large-scale psilocybin manufacturing processes; psilocybin formulations and compositions; razoxane formulations and compositions; and methods of treatment using psilocybin. Their patent portfolio includes patent applications in varying stages of prosecution in the United States and 38 selected ex-U.S. jurisdictions covering the therapeutic methods for using psilocybin and compo. The company expects to submit additional provisional patents in 2021 related to the manufacturing and formulating of psilocybin.
Tryp added three names to its Scientific Advisory Board recently including Robin Carhart-Harris, Ph.D. (Imperial College of London), Joel Castellanos, M.D. (UC San Diego), and William Schmidt, Ph.D.
Last year the company announced a research collaboration with Jennifer Miller of the University of Florida. Dr. Miller will be the principal investigator for a Phase 2a clinical trial for eating disorders using Tryp’s psilocybin-based treatments. Dr. Miller is a leading expert in certain eating disorders including binge eating and hyperphagia and brings a wealth of experience in treating these conditions. The trial has commenced and we are still waiting on the results.
Other addictive behaviors like nicotine addiction have been previously studied at Johns Hopkins. In 2014, Johns Hopkins University published the results of their study measuring the safety and efficacy of psilocybin in treating tobacco addiction. At the 6-month follow-up, 80% of the participants were abstinent. A longer-term follow-up study showed 67% of the participants remained abstinent after 12 months. Psilocybin is also known to activate serotonin receptors. Serotonin curbs cravings and shuts off appetite, and can reduce eating and cause weight loss
Tryp is hopeful that a similar breakthrough could happen for eating disorders. If addictions are similar in how they function, Tryp could have something here. Addiction is complex, but there is both an obsessive and compulsive aspect to it. Members of 12 step groups often talk about how it doesn’t matter what the substance was, it was the intent and the thought process before the substance was even taken.