Entropy Neurodynamics Limited (ASX:ENP, OTC:TYPTF) has dosed the first participant in its clinical trial evaluating TRP-8803 — an intravenously infused formulation of psilocin — for the treatment of binge eating disorder (BED), marking the first clinical use of IV psilocin in a neuropsychiatric condition.
The patient, enrolled in the study conducted alongside Swinburne University, received a therapeutic mid-range dose via a 140-minute infusion on December 1. The controlled delivery allowed clinicians to precisely modulate onset, depth and duration of the psychedelic experience, a key distinction from oral psilocybin, where variability in absorption remains a major challenge, according to Entropy, formerly known as Tryptamine Therapeutics.
The participant progressed well through treatment, completed post-dose follow-up and was discharged the same day. A second dose is scheduled for December 15 as part of the protocol, which pairs each administration with supportive therapy.
Trial advancing with more patients in the pipeline
Entropy’s clinical trial aims to recruit 12 BED patients across two six-person cohorts, with each participant receiving two doses of TRP-8803, 14 days apart and supported by psychotherapy. The first cohort will assess a mid-range dose, while a second cohort will evaluate a higher dose.
Entropy says additional enrolments are progressing, with the second patient completing baseline assessments ahead of dosing planned for January. Top-line results from the first cohort are expected early in the March quarter of 2026.
The company’s focus on TRP-8803 — which delivers psilocin directly via infusion — is central to its strategy of achieving more predictable therapeutic outcomes. By bypassing oral conversion, the approach offers rapid onset, tighter dose control and shorter intervention times, making the therapy more practical for clinical adoption.
Pivotal milestone after years of development
CEO Jason Carroll said the first dosing event marks a major clinical and operational step forward for Entropy.
“This development follows four years of scientific development, extensive work alongside Swinburne University, and demonstrates our capability to execute on our clinical strategy,” Carroll said.
“With additional enrolments advancing well and our second patient undertaking baseline assessment, we remain firmly on track to deliver top-line results in Q1 CY26,” he added. “Importantly, TRP-8803’s controlled infusion profile allows us to precisely tailor the onset, depth and duration of the administered dose. This level of dose control is critical for ensuring patient safety, enhancing therapeutic predictability and advancing our broader goal of bringing first-in-class neuropsychiatric therapy into late-stage development.”
Building on strong data from earlier studies
Entropy’s previous Phase 2a trial using TRP-8802 (oral psilocybin) in BED reported an average reduction in binge-eating episodes of more than 80%, supporting the rationale for progressing to the more controlled TRP-8803 platform.
The company is also pursuing trials in fibromyalgia and irritable bowel syndrome, each initially using oral psilocybin to establish clinical benefit before potentially transitioning to IV psilocin in later studies.
For Entropy, the BED trial represents a critical proof point for TRP-8803 as a precision-delivery psychedelic therapy — one the company believes could unlock broader clinical and commercial potential across neuropsychiatric and pain-related indications.