Early clinical data presented at the ECNP Congress show predictable psychedelic effects and measurable changes in brain activity, as the Australian biotechnology company evaluates a shorter treatment protocol.
Australian biotechnology company Entropy Neurodynamics (ASX: ENP) has presented new clinical findings from its intravenous psilocin programme, reporting rapid and consistent psychedelic effects in patients with binge eating disorder (BED).
The findings, presented at the 39th European College of Neuropsychopharmacology (ECNP) Congress in Munich from 10–13 October 2026, draw on the first six participants in the company’s ongoing Phase 1 clinical trial of TRP-8803.
Across 12 dosing sessions, researchers observed a mean peak psychedelic intensity of 9.4 out of 10, with seven sessions reaching peak intensity within 20 minutes of infusion commencement. Nine sessions achieved the maximum reported intensity of 10 out of 10.
The results provide preliminary evidence of the consistency of TRP-8803’s psychedelic effects, supporting Entropy’s development of an intravenous alternative to conventional oral psilocybin administration.
Early Clinical Findings
TRP-8803 is Entropy’s proprietary intravenous formulation of psilocin, the active metabolite responsible for the psychedelic effects of psilocybin.
Unlike oral psilocybin, which must be absorbed through the gastrointestinal system and converted into psilocin, intravenous administration delivers the active compound directly into the bloodstream. The approach is intended to provide greater control over the onset, intensity and duration of treatment.
The Phase 1 study, conducted with researchers at Swinburne University of Technology, enrolled six adults with a confirmed diagnosis of binge eating disorder.
Participants received two intravenous dosing sessions approximately two weeks apart, alongside preparatory psychotherapy and post-treatment integration sessions.
Under the initial protocol, participants received 10 mg of psilocin over 140 minutes, comprising a 5 mg loading dose administered over 20 minutes followed by a 5 mg maintenance infusion over 120 minutes.
Five of the six participants reported the same maximum psychedelic intensity across both dosing sessions. Among sessions reaching maximum intensity, the median time spent at that level was approximately 100 minutes.
The conference poster also reported a median duration of psychedelic effects of 240 minutes from infusion commencement.
Safety and Tolerability
The preliminary findings indicated that TRP-8803 was generally tolerated across the 12 treatment sessions, with no serious adverse events or treatment discontinuations reported.
However, all six participants experienced at least one adverse reaction.
The study recorded 88 adverse reactions, of which 87 were classified as mild or moderate. One Grade 3 adverse reaction involving suicidal ideation was reported.
Other recorded reactions included fatigue, headache, nausea, anxiety and insomnia.
These findings provide initial safety information for intravenous psilocin administration in patients with binge eating disorder, although the small sample size limits conclusions about its broader safety profile.
The trial remains at an early stage, and the results presented primarily concern safety, tolerability and the characteristics of the psychedelic experience rather than definitive clinical efficacy.
EEG Analysis Identifies Rapid Changes in Brain Activity
A second poster presented at the congress examined changes in brain activity during intravenous psilocin administration using electroencephalography (EEG).
The exploratory analysis, conducted in a single participant, identified measurable changes in brain activity approximately 11 minutes after infusion commencement.
These changes developed during the acute dosing period and returned towards pre-treatment baseline levels following treatment.
The findings offer an initial neurophysiological assessment of how brain activity changes during a controlled psilocin infusion.
Entropy said broader EEG analysis is underway to determine whether similar patterns can be identified across the clinical dataset.
While the results remain preliminary, the ability to continuously monitor brain activity alongside a precisely timed infusion may provide researchers with additional information about the relationship between drug administration, subjective psychedelic effects and neurological responses.
Entropy Moves to Shorter Infusion Protocol
The latest findings also inform Entropy’s ongoing evaluation of a shorter TRP-8803 treatment regimen.
The company has commenced Cohort 2 of its binge eating disorder programme, which is examining whether a 60-minute infusion can maintain the psychedelic experience and clinical outcomes observed under the original 140-minute protocol.
Reducing treatment duration is a central objective of Entropy’s development strategy.
Conventional psychedelic-assisted therapy can require lengthy supervised treatment sessions, creating practical challenges for clinical facilities, staffing and patient access.
A shorter, more predictable administration period could potentially improve treatment capacity and reduce delivery costs, although the overall duration of psychedelic effects and required clinical supervision will also influence those outcomes.
Entropy Chief Executive Officer Jason Carroll said the findings supported further investigation of the company’s intravenous approach.
“Together, these findings help explain why we believe precision-controlled IV-psilocin has the potential to overcome the limitations associated with conventional psychedelic administration. TRP-8803 is designed to rapidly establish the psychedelic state, maintain drug delivery for a predetermined period and then cease administration.”
Carroll said the company was now examining whether the shorter regimen could preserve the effects observed in the initial cohort.
“The next question is whether we can preserve that experience and the clinical outcomes observed in Cohort 1 within a materially shorter treatment window. This is exactly what we are now evaluating with the 60-minute TRP-8803 regimen in Cohort 2.”
Further Clinical Development
Entropy is developing TRP-8803 as a potential treatment platform across several conditions, building on earlier clinical research involving oral psilocybin in binge eating disorder, irritable bowel syndrome and fibromyalgia.
The latest data add to the company’s understanding of intravenous psilocin administration, particularly its ability to produce consistent subjective effects across repeated dosing sessions.
However, the findings do not yet establish whether TRP-8803 can produce sustained improvements in binge eating symptoms or whether intravenous administration offers superior clinical outcomes compared with oral psilocybin.
Further research will be needed to evaluate treatment efficacy, longer-term safety and the relationship between psychedelic intensity and therapeutic outcomes.
For Entropy, the immediate focus is the ongoing 60-minute infusion cohort, alongside expanded EEG analysis and continued development of TRP-8803 across its clinical programmes.
