Tryp Therapeutics Explores Psilocybin's Potential In New Trials To Treat IBS And Fibromyalgia

Psychedelics biotech Tryp Therapeutics TRYPF is advancing its psilocybin-based portfolio through several recent milestones.

Upcoming Phase 1 For IV Psilocin

First, the company received approval from the Australian Human Research Ethics Committee (HREC) for a Phase 1 study on its IV-infused psilocin, TRP-8803. To take place at the CMAX Phase 1 unit in Adelaide, Australia, the open-label study will assess the safety and pharmacokinetics (PK) of a single intravenous (IV) infusion of the psychedelic in nine healthy adults.

On a broader scale, the trial is designed to determine the optimal blood levels of psilocin to achieve the targeted psychedelic state and, ultimately, provide “a major advance in psychedelic medicine” by optimizing the doses and infusion rates of IV-administered psilocin for targeted blood levels of psilocin. 

The study will also collect real-time electroencephalogram (EEG) data from volunteers to monitor changes in EEG patterns associated with the psychedelic state, providing “invaluable” and believed-to-be first-in-class insights into the correlation between psilocin levels and the depth and duration of the psychedelic experience.

Tryp’s CSO Dr. Jim Gilligan said the study aims to meet three targets of psilocin blood levels which, if proven to be safe, will serve the company as the basis for dose selection in its planned Phase 2 studies. 

Additionally, Tryp anticipates receiving 43.5% of the study costs back in cash via Australia's R&D rebate program, significantly reducing its cost and “validating” the company’s recently-announced plan to redomicile to Australia and list on the ASX, Gilligan added.

Oral Psilocybin For Abdominal Pain Related To IBS + Fibromyalgia

The company will soon begin its Phase 2a clinical trial on oral psilocybin TRP-8802 in patients with abdominal pain and visceral tenderness caused by irritable bowel syndrome (IBS.) 

Conducted in partnership with Massachusetts General Hospital (MGH) following approval by the Institutional Review Board (IRB), the open-label pilot study assessing safety and efficacy of TRP-8802 combined with psychotherapy would start dosing patients in the first half of 2024.

Meanwhile, the first patient of a Phase 2a clinical trial targeting fibromyalgia treatment has been administered TRP-8802. Conducted by the University of Michigan in collaboration with Tryp, the trial combines oral psilocybin with psychotherapy as potential treatment for patients with fibromyalgia. 

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With positive results in this study, Gilligan says Tryp would look to continue clinical development in fibromyalgia with TRP-8803 toward providing “even more favorable outcomes and relief” for patients with chronic pain. Today, nearly one-third of fibromyalgia patients reportedly resort to opiates at some point for pain relief.

In 2023, Tryp plus partner University of Florida completed a Phase 2a trial for binge eating disorder treatment, which showed an average reduction in binge eating episodes of 80%+. 

Portfolio: TRP-8802 & TRP-8803

The company’s proprietary formulation of IV-infused psilocin and lead psilocybin-based drug candidate- TRP-8803 aims to enhance psilocybin and related compounds’ positive effects while alleviating the “numerous shortcomings” of its oral route. These would include “significantly” reducing onset time of the psychedelic state, controlling the psychedelic experience’s depth and duration, and reducing the overall duration of the intervention “to a commercially feasible time frame,” the company says.

Its predecessor, synthetic oral psilocybin TRP-8802, is being used to evaluate the use of psilocybin-related compounds in certain neuropsychiatric disorders in early-stage trials. If initial efficacy is shown, TRP-8803 will be studied in future trials.

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