Entropy Neurodynamics Completes Cohort 1 Enrolment in Psilocin BED Trial
Entropy Neurodynamics (ASX: ENP) has completed full enrolment of Cohort 1 in its TRP-8803 Binge Eating Disorder Trial, with six patients now recruited into the 12-patient study being conducted with Swinburne University. Two patients have already completed both IV-infused psilocin doses, administered 14 days apart alongside supportive therapy, whilst enrolment into Cohort 2 is already underway with two patients enrolled.
Patient dosing progress
Of the six Cohort 1 participants, Patients 1 and 2 have completed both dosing sessions. Patients 3, 4, and 5 have completed their four-week baseline assessments and are scheduled to receive dosing in the coming weeks, whilst Patient 6 has commenced baseline assessment. Cohort 2 patients will commence dosing following completion of dosing and a four-week follow-up from Cohort 1, in accordance with the study protocol.
| Patient | 4-Week Baseline | First Dose | Second Dose |
|---|---|---|---|
| Patient 1 | Complete | Complete | Complete |
| Patient 2 | Complete | Complete | Complete |
| Patient 3 | Complete | Scheduled | Pending |
| Patient 4 | Complete | Scheduled | Pending |
| Patient 5 | Complete | Scheduled | Pending |
| Patient 6 | Underway | Pending | Pending |
Full cohort recruitment demonstrates execution capability and trial feasibility, reducing timeline risk for data readouts and supporting investor confidence in the Company’s operational delivery.
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What is binge eating disorder and why is it difficult to treat?
Binge Eating Disorder (BED) is a serious psychiatric condition characterised by recurrent episodes of eating large quantities of food with a sense of loss of control. It is the most common eating disorder in adults, affecting an estimated 2-3% of the adult population globally.
Current treatment options face significant limitations. Behavioural therapies demonstrate variable success rates across patient populations, whilst pharmacological interventions remain limited. This creates a substantial unmet medical need for novel therapeutic approaches that target the underlying psychological drivers of the condition rather than purely symptomatic management.
Psychedelic-assisted therapy represents a novel treatment paradigm by addressing the neurobiological and psychological mechanisms thought to underpin BED, including mood dysregulation, body image disturbance, and compulsive behavioural patterns. The significant patient population combined with limited effective treatments represents a considerable commercial opportunity for innovative therapeutics.
Early patient results driving recruitment momentum
Recruitment momentum follows clinically meaningful results observed in the first patient treated with TRP-8803, as announced on 22 January 2026. This patient demonstrated multi-domain improvements at the four-week post-treatment assessment, including reductions in binge eating severity, depression, and anxiety, alongside improvements in body image satisfaction and overall wellbeing.
Management believes these early in-human observations have supported patient engagement and trial progression by providing validation of the study protocol and the broader clinical development pathway for TRP-8803 in BED. The positive early signals support the therapeutic rationale and reduce clinical development pathway risk, whilst also demonstrating patient and clinician confidence in the treatment approach.
Trial endpoints and timeline
The study’s primary endpoint is safety and tolerability of two administrations of TRP-8803 over a 12-week observation period following first dosing. Secondary and exploratory endpoints include assessment of:
- Changes in binge eating frequency
- Body mass index (BMI) changes
- Weight-related measures
- Broader psychological parameters
The staged two-cohort design enables dose optimisation based on real-world safety data. The first cohort receives a mid-range therapeutic dose, and based on Cohort 1 results, the second cohort will be administered an optimised dosing regimen. This approach allows efficient clinical development with built-in risk mitigation.
IV-infused psilocin: Entropy’s differentiated approach
TRP-8803 is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin), distinct from oral psilocybin formulations. The IV delivery method offers several reported advantages over oral administration, including faster onset, controlled depth and duration of the psychedelic experience, and reduced overall treatment duration.
These characteristics position the therapy for scalable, clinic-based administration with precision dosing capabilities that oral approaches may not match. The Company’s broader development pipeline includes Phase 2a trials in Irritable Bowel Syndrome and fibromyalgia using oral psilocybin, with results from these trials being used to enhance TRP-8803 development.
The proprietary IV delivery method addresses key practical barriers to psychedelic therapy adoption, potentially enabling commercially feasible treatment protocols suitable for clinical deployment at scale.
Jason Carroll, CEO
“This update reflects strong operational execution across our Binge Eating Disorder programme. With Cohort 1 now fully recruited and dosing progressing well, and early enrolment already progressing in Cohort 2, we are building clear momentum to advance TRP-8803.”
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Next steps for Entropy Neurodynamics
The remaining Cohort 1 patients are scheduled to complete dosing in the coming weeks. Cohort 2 dosing will follow after Cohort 1 completion and the four-week follow-up period, in accordance with the study protocol.
The Company aims to characterise safety, tolerability, and efficacy across two dose ranges, with the structured design enabling systematic dose-response assessment. This data will support dose selection for potential Phase 2b/3 advancement whilst building a robust clinical dataset.
Management has stated it remains focused on disciplined clinical execution, generating robust datasets, and positioning TRP-8803 as a scalable treatment option in BED and broader neuropsychiatric indications. The systematic evaluation of dose-response relationships positions Entropy to optimise the therapeutic protocol for future clinical development stages.
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