California-based Tryp Therapeutics joins other sector leaders with Phase II clinical trials
Tryp’s strategy isn’t to steward its drug candidates right through to an FDA approval. Rather, the company hopes to demonstrate their efficacy in the treatment of a range of neuropsychiatric and chronic pain conditions via Phase 2a proof of concept trials, which it understands to be the value inflection point. This strategy, coupled with the company’s plans to utilise the FDA’s 505(b)(2) pathway, which allows for third party data to be invoked in lieu of Phase 1 trials, could present a significantly shortened route to profitability.
The company is focusing on developing clinical-stage compounds for diseases with unmet treatment needs. In the words of CEO Dr. James Kuo, Tryp intends “to go where the medical need is greatest and the potential reward for patients as well as our investors will be the highest.” In practice, the company has a pipeline that will investigate both psychedelic (psilocybin-based formulations) and non-psychedelic drugs; though in documents reviewed by Psilocybin Alpha, it is clear that its Psilocybin for Neuropsychiatric Disorders (PFN ™) Program is the facet of the pipeline the company is investing in most heavily.
Tryp recently announced its first clinical trial, which is currently in the planning stage. The company intends to explore psilocybin for over-eating disorders as part of a Phase 2a trial. Below, we expand on the company’s strategy as it pertains to the clinical trial pathway.
An Expedited Clinical Trials Pathway?
Tryp believes it will be able to harness existing human safety data pertaining to its drug candidates in order to expedite or avoid Phase 1 clinical trials. The purpose of a Phase 1 trial is to ascertain the safety of a drug (see our glossary). Given that clinical trials are expensive and time-consuming endeavours (Sertkaya et al., 2016; Martin et al., 2017), the potential to draw on an existing pool of safety data and effectively bypass Phase 1 may be an attractive proposition.
The company understands that both psilocybin and razoxane, the active pharmaceutical ingredients in TRP-8802 and TRP-1001, boast enough third-party preclinical and clinical data for this expedited pathway to be pursued. For those looking to dive deeper into the regulatory pathway under discussion, you may review the FDA’s 505(b)(2) documentation.
A Shorter Route to Market?
Drug discovery, development, and marketing is an expensive and time-consuming process. As such, many companies operating in this segment of the value chain seek to protect their inventions and operations via a bevy of intellectual property (IP) tools; patents being the most obvious. Tryp is clearly aware of this, as Kuo explained to Psilocybin Alpha:
“The Tryp team members have spent their entire careers in the biopharma industry and everyone recognizes the critical importance that intellectual property plays in a successful drug development and commercialization plan.”
While some companies and organisations in the psychedelics space are set on stewarding their lead candidates through the entire clinical trial and regulatory approval pathway (e.g., MAPS for MDMA-assisted psychotherapy; COMPASS Pathways & Usona Institute for Psilocybin-assisted psychotherapy), Tryp Therapeutics aims to focus on the value inflection point, which Kuo claims is the Phase 2 proof of concept clinical trial; or, Phase 2a.
According to Kuo, this is the point at which a trial sponsor enrols just enough patients to demonstrate significant clinical efficacy. Once this efficacy is apparent, Tryp intends to license, sell or partner for further development of its drug candidates, in a strategy that Kuo hopes will “de-risk the further development of the drug candidates and provide a return for investors within a much faster time period.”
Tryp’s Planned Phase 2a Trial
This broader strategic model contextualises the company’s Phase 2a clinical trial, announced on February 8th. The proof of concept study, which is being planned in collaboration with Dr Jennifer Miller of the University of Florida, seeks to evaluate the efficacy of TRP-8802 in the treatment of rare and orphan over-eating disorders. According to Dr Miller, “There are currently no approved drugs and only limited options to treat patients with rare over-eating disorders.”
In this trial, Tryp Therapeutics will aim to demonstrate the efficacy of its orally-delivered synthetic psilocybin-based formulation (TRP-8802). Should the study commence, Tryp would become one of the handful of public psychedelics companies engaged in Phase 2 trials, with the majority operating at the discovery, preclinical, or Phase 1 stage.
Tryp’s First Year as a Public Company
The California-based company has made a number of other announcements in 2021 thus far. In early February, Tryp added leading psychedelics researcher Dr. Robin Carhart-Harris to its Scientific Advisory Board. Dr. Carhart-Harris heads up Imperial College London’s Centre for Psychedelic Research, and is a prolific author of peer-reviewed work. Commenting on his appointment, Carhart-Harris noted that, “amidst the rapid growth that is occurring in the psychedelic pharmaceutical space, Tryp stands out as one of the most well operated companies I have come across.”
Tryp also announced a strategic investment from Marc Lustig to the tune of $2m. Lustig founded Origin House, a cannabis brands and distribution company acquired by Cresco Labs in an all-stock deal worth $1.1 billion.
The company will hope to draw on the experience of its Scientific Advisory Board, but also its executive team who—according to Report on Psychedelics—”have a combined 120+ years of experience in drug development, clinical trials, and successfully bringing drugs to market through the FDA regulatory pathway.”
As its first year as a publicly-traded company, Kuo told Psilocybin Alpha that his focus for Tryp was to bring its “drug candidates into clinical testing so we can obtain initial efficacy data as soon as possible.” The company looks poised to achieve this goal, with a Phase 2a already in the works.
Find out more about Tryp Therapeutics, including the latest news from the Company, by visiting its Psilocybin Alpha Company Profile.
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