Entropy Doses Third Patient as Psychedelic Drug Hits Target Response Every Time

Entropy Neurodynamics has dosed its third patient in the TRP-8803 binge eating disorder clinical trial, with all patients dosed to date achieving a full and controlled psychedelic response. The third patient received their first infusion on 24 March 2026, followed by a second infusion on 9 April 2026, demonstrating TRP-8803’s ability to deliver precise control over the onset, depth, and duration of the psychedelic experience.

The trial, conducted alongside Swinburne University, aims to recruit 12 patients across two six-patient cohorts. Each patient receives two TRP-8803 infusions 14 days apart, combined with supportive psychotherapy. The consistent achievement of psychedelic responses across multiple patients validates TRP-8803’s core value proposition: precision delivery of psilocin that bypasses the variability inherent in oral psilocybin metabolism.

Cohort 1 nearing completion as Cohort 2 enrolment advances

Cohort 1 dosing is nearing completion, with five patients having commenced or completed baseline assessments and three fully dosed. In parallel, four patients have already been enrolled into Cohort 2, who will commence dosing following Cohort 1’s completion of the 4-week follow-up period in accordance with the study protocol.

Cohort 1 receives a mid-range therapeutic dose, whilst Cohort 2 will be administered an alternate dosing regimen informed by Cohort 1 outcomes. The study’s primary endpoint is safety and tolerability of two TRP-8803 administrations over a 12-week observation period. Secondary endpoints include assessment of changes in binge eating frequency, body mass index (BMI), weight-related measures, and broader psychological parameters.

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

TRP-8803 is Entropy’s proprietary IV-infused psilocin formulation. Unlike oral psilocybin, which must be metabolised in the digestive system before converting to psilocin, TRP-8803 delivers psilocin directly into the bloodstream.

This distinction is crucial for clinical deployment. Oral psilocybin produces highly variable effects between patients due to differences in individual metabolism and absorption rates. The time to onset, intensity, and duration of the psychedelic experience can vary significantly, creating challenges for safety monitoring and standardised clinical protocols.

TRP-8803’s intravenous delivery enables predictable onset, controlled depth, and defined duration of the psychedelic experience. Clinicians can anticipate when the psychedelic state will begin, manage its intensity in real time, and know when it will resolve. This level of control is essential for safety, scalability, and regulatory acceptance.

The ability to standardise psychedelic experiences addresses a fundamental barrier to commercialisation in the psychedelic therapy sector. Controlled delivery allows for shorter, more feasible treatment sessions compared to oral psilocybin’s extended and unpredictable timeframes. This reproducibility is critical for real-world clinical deployment beyond research settings.

Early clinical signals show multi-domain improvements

The first patient treated in the study, who completed their 4-week post-treatment assessment, demonstrated clinically meaningful improvements across multiple symptom domains. Following two TRP-8803 infusions administered alongside supportive psychotherapy, the patient showed:

• Reductions in binge eating severity
• Reductions in anxiety and depression
• Improvements in emotional regulation
• Improvements in overall wellbeing

These results, announced 22 January 2026, exceeded the expectations of clinical investigators. All patients dosed to date have attained a psychedelic response, underpinning confidence in TRP-8803’s ability to reliably induce the therapeutic state required for psychedelic-assisted therapy.

The multi-domain benefits suggest TRP-8803 may address both behavioural drivers and underlying psychological factors in binge eating disorder. This differentiates the approach from existing treatments that typically target single symptom dimensions, such as reducing binge frequency without addressing comorbid mood disorders or emotional dysregulation.

Understanding binge eating disorder as a target indication

Binge eating disorder is the most common eating disorder, affecting an estimated 2-3% of the population. This makes BED more prevalent than anorexia and bulimia combined. The condition is characterised by recurrent episodes of uncontrolled overeating, accompanied by distress, loss of control, and impaired functioning.

BED is frequently associated with obesity, depression, anxiety, and reduced quality of life. In clinical settings, particularly among individuals with obesity or metabolic disease, prevalence rates are significantly higher than in the general population.

Current treatment options include psychotherapy (specifically Cognitive Behavioural Therapy-Enhanced), lisdexamfetamine (the only FDA-approved medication for BED), and off-label antidepressants. However, many patients experience incomplete response, relapse, or intolerable side effects, leaving a substantial population with refractory BED and limited effective alternatives.

The significant unmet medical need, combined with limited approved treatments, creates a clear market opportunity. BED’s association with compulsive behaviours, emotional dysregulation, and mood disorders aligns with psychedelic therapy’s demonstrated mechanisms of action in addressing maladaptive reward pathways and improving emotional regulation.

Near-term catalysts and clinical expansion plans

Entropy has outlined a series of upcoming milestones that will provide multiple data points over the coming months:

1. Completion of Cohort 1 dosing and 4-week follow-up (expected in coming weeks)
2. Initiation of Cohort 2 dosing (following Cohort 1 completion and Safety Board clearance)
3. BED trial results (expected during Q3 CY26)
4. Launch of significantly larger clinical trial (scheduled to commence Q2 CY26)
5. Expansion into additional neuropsychiatric indications (planned for near term)

Jason Carroll, Chief Executive Officer

“Completion of dosing for our second and third patients highlights continued, disciplined progress across the TRP-8803 clinical programme and reinforces our ability to deliver consistent and controlled psychedelic experiences using our IV-infused psilocin platform. With Cohort 1 dosing nearing completion and Cohort 2 already enrolling, we are building strong momentum and expect a steady flow of clinical data over the coming months. We remain confident in TRP-8803’s ability to offer a differentiated, clinically deployable approach to psychedelic-assisted therapy as we advance towards broader development across eating disorders and other neuropsychiatric indications in the near term.”

The steady flow of clinical data expected over the coming months provides multiple potential catalysts for the company. The larger clinical trial commencing this quarter represents a meaningful step-up in development scale, moving beyond proof-of-concept towards validation of the platform’s broader therapeutic potential.

The BED study serves as the first step in validating TRP-8803’s precision-controlled psychedelic delivery platform. Data from both cohorts will inform dose selection and design for future clinical studies, whilst expansion into additional neuropsychiatric conditions positions TRP-8803 as a platform technology rather than a single-indication asset.

Don’t Miss the Next Biotech Breakthrough

Join 20,000+ investors getting FREE breaking ASX healthcare news delivered to your inbox within minutes of release, complete with in-depth analysis. Click the “Free Alerts” button at StockWire X to stay ahead as biotech companies announce clinical trial results, regulatory milestones, and market-moving developments the moment they hit the ASX.