Tryptamine’s Bold BED Trial: Will Funding and Recruitment Keep Pace?
Tryptamine Therapeutics has initiated the first-ever clinical trial using IV-infused psilocin to treat Binge Eating Disorder, with patient dosing set to begin shortly and results expected by year-end.
- World-first clinical trial for BED using TRP-8803 underway with Swinburne University
- Trial to recruit 12 patients receiving two doses 14 days apart
- New Chairman Herwig Janssen appointed, bringing 40+ years pharma experience
- Cash position of $3.03m plus anticipated $0.8m R&D tax refund
- Multiple clinical programs progressing alongside BED trial
A Pioneering Step in BED Treatment
Tryptamine Therapeutics Limited (ASX, TYP) has embarked on a world-first clinical trial targeting Binge Eating Disorder (BED) with its lead drug candidate, TRP-8803, an intravenous formulation of psilocin. Partnering with Swinburne University, the open-label study aims to evaluate the safety and efficacy of this novel treatment combined with psychotherapy in adult patients.
The trial will enrol 12 participants divided into two cohorts, each receiving two doses of TRP-8803 spaced 14 days apart. The first cohort will receive a mid-range dose, while the second will be administered a higher dose. This approach is designed to assess safety over a 12-week follow-up and explore the drug’s impact on binge-eating frequency and related weight indicators.
Clinical and Market Context
BED is the most common eating disorder in the United States and the second most prevalent in Australia, often accompanied by psychiatric comorbidities such as depression, anxiety, and PTSD. Current treatment options are limited, making the potential of psilocin; a psychedelic compound known for its neuropharmacological effects; particularly compelling.
Previous studies by Tryptamine Therapeutics, including a Phase 2a trial at the University of Florida using oral psilocybin, demonstrated over 80% improvement in binge eating scores, providing a promising foundation for this intravenous trial.
Strategic Board Enhancements and Financial Position
In a significant corporate development, the company appointed Herwig Janssen as Non-Executive Chairman. Janssen brings over four decades of pharmaceutical industry leadership, including senior roles at Johnson & Johnson, and is expected to guide the company’s commercialisation strategy effectively.
Additionally, Chris Ntoumenopoulos transitioned to Executive Director, increasing operational and market engagement as the company advances its clinical programs. Financially, Tryptamine Therapeutics reported a cash balance of $3.03 million at the end of June 2025, with an expected R&D tax refund of approximately $0.8 million, positioning the company to fund ongoing and upcoming trials.
Looking Ahead
Patient recruitment has commenced post-quarter, with first dosing anticipated within the current quarter and top-line results expected by Q4 2025. Beyond BED, the company is exploring TRP-8803’s potential in other neuropsychiatric conditions lacking effective treatments, signaling a broad clinical development horizon.
As the trial progresses, the industry will be watching closely to see if this innovative approach can deliver a new therapeutic avenue for BED, a disorder with significant unmet medical needs.
Bottom Line?
Tryptamine Therapeutics is poised at a critical inflection point as it advances a pioneering BED trial that could reshape treatment paradigms.
Questions in the middle?
- Will TRP-8803 demonstrate a clear safety and efficacy profile in the BED population?
- How quickly can the company scale patient recruitment and manage trial logistics?
- What are the commercial prospects if the trial results confirm clinical benefits?
