Second Patient Enrolled as Tryptamine Schedules December Dosing for TRP-8803 in BED
Tryptamine Therapeutics has enrolled its second patient in a pioneering clinical trial using IV-infused psilocin to treat Binge Eating Disorder, with first dosing scheduled for December and results expected early next year.
- Second patient enrolled in world-first TRP-8803 trial for Binge Eating Disorder
- First patient dosing scheduled for 1 December 2025
- Trial involves 12 patients across two dose cohorts with supportive therapy
- Butterfly Foundation supports recruitment and awareness efforts
- Top-line results anticipated in Q1 2026
A New Frontier in Treating Binge Eating Disorder
Tryptamine Therapeutics Limited (ASX, TYP) has marked a significant milestone in its clinical development program by enrolling the second patient in its world-first trial evaluating TRP-8803, an intravenous formulation of psilocin, for the treatment of Binge Eating Disorder (BED). This progress comes as the company prepares to dose the first patient on 1 December 2025, setting the stage for a novel approach in addressing this often overlooked and stigmatized condition.
Trial Design and Patient Recruitment
The trial, conducted in collaboration with Swinburne University, aims to recruit a total of 12 patients divided into two cohorts of six. Each participant will receive two doses of TRP-8803 spaced 14 days apart, combined with supportive psychotherapy. The first cohort will receive a mid-range dose, while the second will be administered a higher dose, allowing researchers to assess safety and efficacy across different exposure levels.
Extensive screening and baseline assessments are underway to ensure patient suitability and safety, including psychological evaluations and comprehensive laboratory testing. The involvement of the Butterfly Foundation, Australia’s leading charity dedicated to eating disorders, has been instrumental in raising awareness and supporting patient recruitment efforts, highlighting the growing recognition of BED as a serious mental health issue requiring innovative treatments.
Implications for Psychedelic-Assisted Therapies
TRP-8803 represents a proprietary intravenous formulation of psilocin, the active metabolite of psilocybin, designed to improve upon oral psilocybin treatments by offering faster onset, controlled psychedelic experiences, and shorter intervention durations. This trial is the first to administer TRP-8803 specifically in a BED population, potentially opening new therapeutic pathways for a disorder that affects hundreds of thousands of Australians annually but remains under-treated.
CEO Jason Carroll emphasized the significance of this milestone, noting that the scheduled dosing and ongoing recruitment efforts mark a pivotal step forward for both the company and the broader field of psychedelic-assisted treatment. The collaboration with the Butterfly Foundation further underscores the importance of community engagement and education in advancing clinical research and reducing stigma.
Looking Ahead
With first patient dosing imminent and additional enrolments expected shortly, Tryptamine Therapeutics is on track to report top-line results in the first quarter of 2026. These findings will be closely watched by investors, clinicians, and advocates alike, as they could validate a new, evidence-based treatment option for BED and potentially pave the way for broader applications of intravenous psilocin in mental health.
Bottom Line?
As Tryptamine Therapeutics moves from enrolment to dosing, the coming months will be critical in defining the future of psychedelic therapies for eating disorders.
Questions in the middle?
- How will patients respond to the mid- versus high-dose TRP-8803 in terms of efficacy and safety?
- What role will the Butterfly Foundation play in sustaining recruitment and post-trial support?
- Could positive results accelerate regulatory approval and commercialisation pathways for TRP-8803?
