Entropy Doses First Patient in IV Psilocin BED Trial

Highlights

• First patient dosed in a trial of IV psilocin for binge eating disorder

• Protocol uses controlled infusion with supportive therapy sessions

• More enrolments underway with initial cohort results expected in 2026

Entropy has dosed the first patient in its TRP-8803 trial for binge eating disorder, using IV psilocin with supportive therapy. The next focus is enrolment progress and the first cohort readout.

Clinical trial milestones can reshape how a development-stage biotech is viewed, especially when a program moves from planning into real-world dosing. Entropy Neurodynamics Limited (ASX:ENP), which is a neuropsychiatric therapeutics developer formerly known as Tryptamine Therapeutics, has dosed the first participant in its clinical trial evaluating TRP-8803—an intravenously infused formulation of psilocin—for binge eating disorder. The company says this marks the first clinical use of IV psilocin in a neuropsychiatric condition, with the study conducted alongside Swinburne University.

What is TRP-8803 and why does IV delivery matter?

TRP-8803 is designed to deliver psilocin through intravenous infusion rather than relying on an oral pathway. In plain terms, the aim is to create a more controllable and predictable treatment session.

What problem is the trial trying to solve?

Oral psychedelic delivery can involve variability in absorption and timing, which can affect onset and intensity. A controlled infusion approach is intended to help clinicians better manage:

• the onset of the experience,

• the depth of the experience,

• the duration of the session.

That control is often positioned as a practical advantage for clinical settings, where consistency and safety processes matter.

What happened with the first patient dosing?

Entropy reported that the first enrolled participant received a therapeutic mid-range dose delivered via a single infusion session. The participant progressed well through treatment, completed follow-up, and was discharged the same day, matching the company’s emphasis on a structured, clinic-friendly protocol.

How is the trial designed?

The trial is structured to recruit a total group of participants split into two cohorts.

How many participants are planned?

Entropy’s stated recruitment target is a small early-stage clinical cohort, separated into two groups. Each group is intended to help evaluate dosing levels and session management.

How many doses does each participant receive?

Each participant is scheduled to receive two administrations spaced about two weeks apart, and each dosing session is paired with supportive therapy. This kind of design reflects the broader model used in psychedelic-assisted therapy programs, where psychological support is a core component of treatment delivery rather than an add-on.

What is the difference between the cohorts?

The first cohort is intended to assess a mid-range dose, while the second cohort is intended to test a higher dose. This allows early comparison of tolerability, session dynamics, and signals of potential benefit across dosing intensity.

What are the next milestones?

Entropy indicated that further enrolments are moving forward, with additional participants progressing through baseline assessments.

When are early results expected?

The company has guided to top-line results from the first cohort in the early part of the March quarter 2026. For readers tracking development-stage names, that timing matters because it gives a clearer window for what the next data-driven catalyst could look like.

Why is this milestone strategically important for the company?

For early-stage therapeutics developers, the first participant dosed is more than a headline. It demonstrates operational readiness across:

• trial site coordination,

• protocol execution,

• dosing logistics and monitoring,

• post-dose follow-up handling.

It also shifts the market conversation from “the trial is planned” to “the trial is underway,” which can be an important credibility step in clinical development.

How does this build on previous BED work?

Entropy has referenced earlier work using an oral psilocybin approach in binge eating disorder that showed strong reductions in binge-eating episodes. The company’s narrative is that TRP-8803 is a next step aimed at improving predictability and controllability in treatment delivery.

What else is in the company’s pipeline?

The company has also described pursuing studies in conditions such as fibromyalgia and irritable bowel syndrome, with an approach that can begin with oral formulations to explore clinical signals before considering infusion-based delivery later. This “stepwise” strategy reflects a common biotech approach: establish evidence of benefit first, then refine delivery and scalability.

What should readers keep in mind when reading early-stage psychedelic trial updates?

A grounded lens is useful here. Early dosing updates confirm progress, but they do not establish efficacy on their own. The most decision-relevant information typically arrives later through:

• cohort readouts,

• safety and tolerability summaries,

• consistent outcome patterns across participants,

• clarity on how results translate into later-stage trial design.