Entropy Neurodynamics reports encouraging early clinical results from the first patient treated with TRP-8803, an IV-infused psilocin therapy for Binge Eating Disorder, showing improvements across multiple symptom areas.
- First patient in TRP-8803 BED trial completes 4-week follow-up with positive outcomes
- Clinically meaningful improvements in binge eating severity, mood, and emotional regulation
- IV-infused psilocin offers precise control over psychedelic therapy delivery
- Trial to continue with additional patients and dose escalation in 2026
- Potential to transform psychedelic-assisted treatment beyond oral psilocybin
Early Clinical Success
Entropy Neurodynamics Limited (ASX – ENP) has announced promising early results from its clinical trial of TRP-8803, a novel intravenous psilocin formulation, in treating Binge Eating Disorder (BED). The first patient treated with TRP-8803 completed a 4-week follow-up assessment, showing clinically meaningful improvements across a broad range of symptoms including binge eating severity, depression, anxiety, body image satisfaction, and overall wellbeing.
The patient received two infusions of TRP-8803 over three weeks, combined with supportive psychotherapy. Post-treatment reflections revealed increased calmness and control around food, reduced compulsive urges, and improved emotional regulation – key challenges in BED management.
Precision Psychedelic Therapy
Unlike traditional oral psilocybin therapies, TRP-8803’s intravenous delivery allows clinicians to precisely control the onset, intensity, and duration of the psychedelic experience. This control is expected to enhance safety, therapeutic impact, and scalability. Professor Susan Rossell, Principal Investigator at Swinburne University, highlighted that this approach appears to facilitate meaningful behavioural and emotional changes, potentially revolutionising psychedelic-assisted therapy.
Entropy’s CEO, Jason Carroll, described the results as a major milestone, transitioning TRP-8803 from a theoretical improvement to an asset with emerging human evidence. The multi-domain improvements align with prior findings from related trials, reinforcing confidence in the clinical potential of IV-delivered psilocin.
Next Steps in Clinical Development
Following the successful first patient outcome, the trial will proceed with five additional patients in the same dose cohort during the current quarter. Subsequently, a higher dose cohort will be evaluated to systematically assess dose response, safety, and durability of clinical benefits. Results from these cohorts are expected in the first half of 2026 and will guide further trial design and regulatory engagement.
BED is a common and complex eating disorder characterised by recurrent binge episodes linked to emotional triggers and mood disturbances. Psychedelic-assisted therapy’s potential to improve emotional regulation and behavioural flexibility makes it a compelling treatment avenue.
Broader Implications
TRP-8803’s development builds on prior Phase 2a trials using oral psilocybin for BED and other conditions, aiming to overcome limitations such as variable onset times and long session durations. If successful, this IV formulation could set a new standard for psychedelic therapies, offering more predictable and commercially viable treatment protocols.
While these early results are encouraging, they are based on a single patient’s short-term follow-up. The broader efficacy, safety, and long-term durability of TRP-8803’s effects remain to be established as the trial progresses.
Bottom Line?
As Entropy advances its trial, TRP-8803 could redefine psychedelic therapy for eating disorders and beyond.
Questions in the middle?
- Will TRP-8803’s benefits sustain over longer follow-up periods and larger patient groups?
- How will higher doses impact safety and therapeutic outcomes in subsequent cohorts?
- Can IV-infused psilocin gain regulatory approval and commercial adoption over oral alternatives?