Can IV Psilocin Transform Treatment for Common and Complex Binge Eating Disorder?
Tryptamine Therapeutics has begun recruiting patients for a pioneering clinical trial testing IV-infused psilocin combined with psychotherapy to treat Binge Eating Disorder, aiming to deliver faster and more controlled treatment outcomes.
- Patient recruitment started for first-ever IV psilocin trial targeting Binge Eating Disorder
- Open-label study to enroll 12 adults in two dose cohorts with dosing this quarter
- Trial conducted in partnership with Swinburne University, with results expected Q4 2025
- BED is a highly prevalent disorder with significant psychiatric comorbidities
- TRP-8803 aims to improve on oral psilocybin by reducing onset time and treatment duration
A New Frontier in Treating Binge Eating Disorder
Tryptamine Therapeutics Limited (ASX, TYP) has taken a significant step forward in the treatment of Binge Eating Disorder (BED) by commencing patient recruitment for a world-first clinical trial using TRP-8803, an intravenous formulation of psilocin. This open-label study, conducted in collaboration with Swinburne University, will assess the safety, efficacy, and feasibility of administering TRP-8803 alongside psychotherapy in adults diagnosed with BED.
Binge Eating Disorder is the most common eating disorder in the United States and the second most prevalent in Australia. It is often accompanied by serious psychiatric comorbidities such as depression, anxiety, PTSD, and compulsive behaviors, underscoring the urgent need for innovative treatment options. The trial aims to address this gap by leveraging the neuropharmacological potential of psilocin, the active metabolite of psilocybin, which has shown promise in earlier studies.
Trial Design and Expectations
The study will recruit 12 patients divided into two cohorts of six, 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, allowing researchers to evaluate dose-dependent effects. Patient screening is set to begin imminently following a strong response to recruitment efforts, with first dosing expected within the current quarter and top-line results anticipated by the end of 2025.
This trial builds on Tryp’s prior Phase 2a clinical trial at the University of Florida, which demonstrated an average reduction in binge eating episodes of over 80% using oral psilocybin. TRP-8803’s intravenous delivery is designed to overcome limitations of oral formulations by significantly reducing the time to onset of the psychedelic experience, controlling its depth and duration, and shortening the overall treatment timeframe to a commercially viable scale.
Strategic Collaboration and Market Potential
The partnership with Swinburne University has been instrumental in advancing the trial, with governance approvals, protocol finalization, and manufacturing schedules now complete. Swinburne has reported substantial inbound interest from potential participants, reflecting the widespread impact of BED and the demand for new therapies.
CEO Jason Carroll highlighted the milestone as a testament to the company’s commitment to pioneering treatments for disorders with unmet medical needs. Success in this trial could unlock a substantial market opportunity for Tryp, given the high prevalence of BED and the limitations of current treatment modalities.
As psychedelic-assisted therapies gain momentum globally, Tryp’s approach with TRP-8803 positions it at the forefront of this emerging field, potentially setting new standards for efficacy, safety, and patient experience in psychiatric care.
Bottom Line?
With patient dosing imminent, all eyes will be on Tryp’s trial results to see if IV psilocin can redefine treatment for a widespread and challenging disorder.
Questions in the middle?
- Will TRP-8803 demonstrate superior efficacy and safety compared to oral psilocybin in BED patients?
- How will the two dosing cohorts differ in therapeutic outcomes and side effect profiles?
- What regulatory hurdles remain before TRP-8803 could reach broader clinical use if trials succeed?
