Safety and Efficacy of IV Psilocin in BED Under the Microscope in New Trial
Tryptamine Therapeutics has secured ethics approval to begin a pioneering clinical trial of TRP-8803, an IV-infused psilocin treatment, targeting adult patients with Binge Eating Disorder. The trial aims to evaluate safety and efficacy, with initial results expected by the end of 2025.
- Ethics approval granted for TRP-8803 trial in Binge Eating Disorder
- Open-label study to dose 12 patients in two cohorts with two infusions 14 days apart
- Patient recruitment underway; first dosing anticipated in Q3 2025
- Trial explores safety, efficacy, and dosing flexibility alongside psychotherapy
- Potential to address neuropsychiatric comorbidities common in BED sufferers
A World-First Clinical Endeavor
Melbourne-based Tryptamine Therapeutics Limited (ASX – TYP) has announced a significant milestone with ethics approval from Swinburne University to commence the first-ever clinical trial of TRP-8803, an intravenous psilocin formulation, for treating adult patients with Binge Eating Disorder (BED). This open-label study will assess the safety and efficacy of the drug when combined with psychotherapy, marking a novel approach in addressing this complex eating disorder.
The trial will enrol 12 participants divided into two cohorts, each receiving two doses of TRP-8803 spaced 14 days apart. The dosing duration differs between cohorts, with one receiving the infusion over 140 minutes and the other over 60 minutes, allowing the company to explore dosing flexibility and its impact on treatment outcomes.
Addressing a Significant Unmet Need
Binge Eating Disorder is the most common eating disorder in the United States and the second most prevalent in Australia, yet it remains under-recognised and inadequately treated. Patients often grapple not only with uncontrollable binge episodes but also with associated conditions such as anxiety, depression, PTSD, and compulsive behaviours. This trial could provide critical insights into TRP-8803’s potential to alleviate both BED symptoms and its neuropsychiatric comorbidities.
TRP-8803’s intravenous delivery offers advantages over oral psilocybin formulations, including faster onset, precise control over the psychedelic experience, and enhanced safety through the ability to halt treatment if adverse effects occur. These features could make it a commercially viable and safer alternative in psychedelic-assisted therapy.
Building on Promising Foundations
This trial builds on encouraging interim data from a prior Phase 2a study using oral psilocybin (TRP-8802) conducted in collaboration with the University of Florida, which demonstrated over 80% improvement in binge eating scores. The current study with TRP-8803 aims to refine and potentially enhance these outcomes through intravenous administration.
Patient recruitment is underway, with first dosing expected in the third quarter of 2025 and top-line results anticipated by the fourth quarter. The outcomes will not only inform the future development of TRP-8803 for BED but may also open avenues for its application in other neuropsychiatric disorders.
Looking Ahead
CEO Jason Carroll emphasised the broader implications of the trial, highlighting the potential for TRP-8803 to address large, unmet medical needs beyond BED. As the company progresses with patient enrolment and data collection, the market will be watching closely for signals of efficacy and safety that could position Tryptamine Therapeutics as a leader in psychedelic-assisted therapies.
Bottom Line?
As Tryptamine Therapeutics embarks on this groundbreaking trial, the coming months will be pivotal in defining TRP-8803’s role in treating complex eating and neuropsychiatric disorders.
Questions in the middle?
- Will TRP-8803 demonstrate superior safety and efficacy compared to oral psilocybin in BED patients?
- How might dosing duration impact therapeutic outcomes and patient experience?
- Could positive results accelerate regulatory approval and broader adoption of IV psilocin therapies?
