Entropy Neurodynamics Ltd Posts 50% Remission in Phase 2 Binge Eating Disorder Trial

Entropy delivers 50% remission in landmark psilocin trial for treatment-resistant binge eating disorder

Entropy Neurodynamics (ASX: ENP) has reported topline Cohort 1 Phase 2 efficacy results for TRP-8803, its precision-controlled IV-infused psilocin therapy, in treatment-resistant Binge Eating Disorder (BED), dated 7 July 2026.

The clinical-stage biotech reported 50% complete clinical remission and 100% clinically meaningful improvement across all treated patients. The Company describes the data as “what the Company believes is the first reported global clinical efficacy data for precision-controlled IV-infused psilocin.”

With Cohort 2 fully enrolled and dosing expected in August, final Phase 2 results are anticipated in Q4 CY26.

Breakthrough efficacy signal across every treated patient

TRP-8803 achieved complete clinical remission, defined as “zero binge-eating episodes in the four weeks after treatment,” in 3 of 6 patients (50%). The remaining participants also recorded clinically meaningful improvements from baseline.

Clinically meaningful improvement, defined as “a 30% improvement on previously recorded baseline scores,” was achieved by 100% of patients. In a chronic, treatment-resistant BED population, this breadth and consistency of response represents a strong early-phase therapeutic signal.

Binge Eating Disorder affects 2-3% of adults globally with limited effective treatments, and the two-cohort trial design was structured specifically to enable dose optimisation and built-in risk mitigation before any advancement to larger Phase 2b or Phase 3 studies.

Multi-domain results at a glance

The trial recorded substantial, consistent benefit across every key efficacy measure, spanning binge-eating behaviour, symptom severity, mood and quality of life.

According to the Company, the anxiety and depression gains are “directionally comparable” to responses observed over 8 to 12 weeks in successful selective serotonin reuptake inhibitor (SSRI) treatment studies, achieved here within four weeks after a single treatment session.

Weight and BMI remained stable, indicating the improvement reflected psychological and behavioural change rather than restrictive dieting.

What is TRP-8803 and precision-controlled IV-psilocin?

TRP-8803 is Entropy’s proprietary formulation of IV-infused psilocin, the active metabolite of psilocybin, delivered directly into the bloodstream.

Unlike oral psilocybin, which must first be metabolised in the gut and liver, direct intravenous delivery is designed to avoid this variability. In Cohort 1, TRP-8803 achieved rapid onset (~20 minutes median), predictable peak intensity (mean 9.4/10) and controlled offset.

For investors, this addresses the practical limitations of oral psilocybin, including variable onset, prolonged 8 to 10 hour sessions and limited dose control once administered. The delivery model is intended to support a more scalable, commercially feasible treatment approach with the following advantages:

• Rapid onset

• Controlled depth

• Predictable duration

• Reproducible exposure

• Real-time dose adjustability

Safety profile and DSMB endorsement de-risk the program

The Independent Data Safety Monitoring Board (DSMB) recommended progression to Cohort 2 without protocol modification, using the protocol-specified 60-minute infusion regimen (ASX announcement, 15 June 2026).

The safety findings from Cohort 1 included:

• No Serious Adverse Reactions

• No SUSARs (Suspected Unexpected Serious Adverse Reactions)

• No discontinuations due to safety events

• Most adverse reactions were mild or moderate

• One Grade 3 event, managed per protocol

For investors, the DSMB endorsement confirms the operational feasibility of the 60-minute infusion regimen and reduces key clinical and operational risks in the TRP-8803 development program.

For readers wanting to understand the safety review process and protocol context behind that decision, our full explainer on the DSMB safety clearance covers the Cohort 1 adverse event data in detail and outlines why the independent board selected the 60-minute infusion regimen over the longer 140-minute alternative.

Why this matters for the investment case

The results support Entropy’s “precision-controlled psychedelic” platform and, according to the Company, provide a foundation for regulatory engagement, partnering discussions and potential expansion into additional neuropsychiatric indications, subject to further clinical validation.

Early EEG analyses have shown consistent entropy-related signatures and reproducible neural dynamics, providing biomarker optionality. The Company notes these are still in development and “not yet validated for clinical decision-making.”

The broader thesis rests on development beyond a single indication, supported by the differentiated delivery platform, though this remains subject to further clinical and regulatory considerations.

CEO Commentary — Jason Carroll

“The most important feature is both the magnitude and consistency of response. TRP-8803 delivered rapid onset, predictable intensity (9.4/10) and controlled offset in every session, supporting our hypothesis that psychedelic therapy can be delivered with medical precision. These results indicate that a high-intensity therapeutic state can be induced reliably and may translate into broad clinical benefit across behaviour, mood and quality of life.

Importantly, this study provides early clinical support for our precision-controlled psychedelic platform and supports development beyond a single indication. Together with the DSMB’s endorsement of our 60-minute infusion protocol, we believe TRP-8803 has the potential to become a clinically practical, scalable and mechanistically coherent psychedelic therapy. We are only at the beginning of what this platform may achieve.”

Next steps and upcoming catalysts

The Company has outlined the following roadmap following Cohort 1:

1. Cohort 2 baseline measurement is expected to commence this month, with dosing expected to begin in August under the DSMB-endorsed 60-minute infusion regimen.

2. Continued advancement of biomarker, EEG and patient dosing analyses.

3. Additional clinical data releases, including durability and predictive biomarker insights.

4. Progression toward broader multi-indication trial planning, subject to further clinical validation and regulatory considerations.

5. Cohort 2 results are expected by year end, with final Phase 2 BED study results expected in Q4 CY26.

Entropy will host an investor webinar on Thursday, 9 July 2026, at 11:00am AEST, hosted by CEO Jason Carroll, including a Q&A session.

Ready to Explore the TRP-8803 Investment Case Further?

Entropy Neurodynamics has delivered a compelling early-phase signal, with 100% of treated patients achieving clinically meaningful improvement and final Phase 2 results anticipated in Q4 CY26. The DSMB-endorsed 60-minute infusion protocol and clean safety profile further strengthen the development pathway for this precision-controlled psilocin platform.

For the latest updates on the TRP-8803 programme, pipeline strategy and upcoming Cohort 2 milestones, explore the Entropy Neurodynamics investor centre to stay across this evolving clinical story.