Entropy Neurodynamics Completes First Cohort Dosing in Binge Eating Disorder Trial

Completion of First Cohort Marks Clinical Milestone

Entropy Neurodynamics (ASX:ENP) has reached a pivotal point in its Phase 2 clinical trial of TRP-8803, an intravenous formulation of psilocin aimed at treating Binge Eating Disorder (BED). All six participants in the first cohort have completed dosing, each receiving two administrations spaced 14 days apart alongside supportive therapy. This cohort was administered a mid-range therapeutic dose.

The trial, conducted in collaboration with Swinburne University, is designed not only to assess safety and feasibility but also to refine the delivery of psychedelic-assisted treatments. The controlled and reproducible psychedelic responses observed across all participants in Cohort 1 are a strong signal supporting the company’s thesis that IV infusion offers advantages over traditional oral psilocybin therapies.

Advantages of IV-Infused Psilocin Highlighted

Entropy CEO Jason Carroll emphasised the significance of achieving a consistent and high-intensity psychedelic experience. Unlike oral therapies, IV-infused psilocin provides rapid onset, predictable pharmacokinetics, precise control over treatment intensity and duration, and rapid reversibility. These factors could translate into shorter, more commercially viable treatment sessions, which are crucial for real-world clinical integration.

The controlled psychedelic effect is not just a safety measure but a potential differentiator that could position TRP-8803 as a scalable and reproducible therapy. This aligns with broader industry efforts to optimise psychedelic medicine delivery to meet regulatory and commercial demands.

Next Steps: DSMB Review and Cohort 2 Dosing

Before progressing to the second cohort, the Data and Safety Monitoring Board (DSMB) will review the Cohort 1 dosing data. This review is expected within weeks and coincides with ongoing patient enrolment efforts; five of the six participants for Cohort 2 are already enrolled. The dosing regimen for the second cohort will be adjusted based on insights from the initial cohort’s outcomes.

Topline results from Cohort 1 are scheduled for release in July 2026. These results will be crucial in informing the optimisation of dosing and treatment protocols, as well as guiding the future clinical development pathway for TRP-8803.

Building on a Foundation of Psychedelic Therapy Research

TRP-8803 builds on Entropy’s earlier Phase 2a trials using oral psilocybin for BED, Irritable Bowel Syndrome, and Fibromyalgia, which demonstrated clinical benefits of psychedelic therapy. The intravenous delivery method aims to overcome limitations such as delayed onset and variable patient responses associated with oral dosing.

With a proprietary formulation and a growing clinical evidence base, Entropy is strengthening its position in the emerging psychedelic therapeutics market. The company’s recent patent filings and clinical progress reflect a strategic push to develop scalable, controlled psychedelic treatments.