Entropy Neurodynamics Advances Controlled Psychedelic Therapy in Binge Eating Disorder Trial

Third Patient Confirms Precision Psychedelic Delivery

Entropy Neurodynamics (ASX:ENP) has successfully dosed the third patient in its clinical trial of TRP-8803, an intravenous psilocin formulation targeting Binge Eating Disorder (BED). This patient experienced a full and controlled psychedelic response, validating the drug’s ability to deliver precise onset, depth, and duration of the psychedelic state; a critical step for scalable therapeutic use.

The trial, conducted in partnership with Swinburne University, plans to recruit 12 patients across two cohorts. Cohort 1, receiving a mid-range dose, is approaching completion, while Cohort 2 has already enrolled four patients and will begin dosing after Cohort 1’s follow-up. This staged approach allows Entropy to fine-tune dosing regimens based on emerging data.

Early Clinical Signals Exceed Expectations

The first patient dosed in the study completed their 4-week post-treatment assessment showing meaningful improvements across multiple symptom domains; including reductions in binge eating severity, anxiety, and depression, alongside enhanced emotional regulation and overall wellbeing. All patients dosed so far have achieved a psychedelic response, reinforcing confidence in TRP-8803’s consistent pharmacodynamic profile.

Entropy’s CEO Jason Carroll highlighted that the IV-infused psilocin platform enables controlled and reproducible psychedelic experiences, a notable advantage over oral psilocybin, which suffers from variable metabolism and unpredictable effects. This precision could be key to regulatory acceptance and real-world clinical deployment.

Trial Design and Next Steps

The study’s primary endpoint focuses on safety and tolerability over a 12-week period following two doses administered 14 days apart, alongside supportive psychotherapy. Secondary endpoints include changes in binge eating frequency, body mass index, weight-related measures, and psychological parameters.

Following Cohort 1 completion and safety review, Cohort 2 dosing will commence, employing an alternate dosing regimen informed by initial findings. Data from both cohorts will guide dose selection and design for a significantly larger clinical trial slated for Q2 2026, which aims to expand TRP-8803’s application to other neuropsychiatric indications.

Positioning TRP-8803 in the Psychedelic Therapy Landscape

TRP-8803’s IV delivery method addresses key limitations of oral psilocybin by providing rapid onset and controlled duration of psychedelic effects, potentially reducing treatment session times and improving scalability in clinical settings. This precision dosing platform recently secured an Australian patent protecting its two-phase infusion method through 2042, strengthening Entropy’s competitive moat.

These developments follow the company’s recent $1.73 million R&D tax incentive refund, which supports ongoing clinical efforts. The combination of promising early clinical outcomes and robust intellectual property positions Entropy to advance a differentiated approach to psychedelic-assisted therapy for BED, a condition affecting 2–3% of the population and currently underserved by existing treatments.