Entropy Neurodynamics Ltd (ASX:ENP, OTC:TYPTF) says the first patient treated with its TRP-8803 (IV-infused psilocin) in a binge eating disorder (BED) trial has completed a 4-week follow-up assessment, with the company reporting “clinically meaningful” improvements across multiple symptom domains.
The patient received two TRP-8803 infusions over three weeks alongside supportive psychotherapy. Entropy said the top-line outcome provides early validation for TRP-8803 and supports ongoing clinical development.
"This first outcome data from the TRP-8803 program in BED represents a major milestone for the company. These initial observations transition TRP-8803 from a theoretical improvement over oral psilocybin, into an asset delivering meaningful patient improvements, supported by emerging in-human evidence," Entropy CEO, Jason Carroll, said.
“The multi-domain improvements observed are consistent with prior TRP-8802 BED findings and reinforce confidence in the clinical potential of controlled, IV-delivered psilocin.”
4-week follow-up outcomes
Entropy reported that, at the four-week post-treatment review, the patient described broad improvements across BED-related symptoms and general wellbeing.
Clinical observations included improvements in:
- binge eating severity
- depression and anxiety
- body image satisfaction
- overall wellbeing
The patient reported feeling calmer and more in control around food, with a reduced urge to continue eating once satisfied, alongside improved emotional regulation.
“From a clinical perspective, the outcomes observed in this first patient are highly encouraging. The combination of precisely controlled IV psilocin delivery with structured psychotherapy appears to facilitate meaningful change across eating behaviour, emotional regulation and broader wellbeing,” Principal Investigator, Professor Susan Rossell, said.
“Based on the results to-date, TRP-8803 has the potential to revolutionise how psychedelic-assisted therapy is delivered in clinical practice, offering a level of control and consistency that is not achievable with oral formulations – the current industry standard. As the trial progresses across additional patients and dose cohorts, we will be able to better understand both the durability and scalability of these effects.”
Dose escalation and remaining Cohort 1 patients
With first-patient dosing and follow-up now complete, and supported by prior clearance from the Drug and Safety Monitoring Board (DSMB), Entropy said the remaining five patients in Cohort 1 will receive a mid-range TRP-8803 dose under the same controlled infusion and psychotherapy protocol during the current quarter.
Cohort 2 and timing for broader readouts
Following Cohort 1, the study is set to progress to Cohort 2, which will evaluate a higher TRP-8803 dose range. The staged design is intended to support systematic assessment of dose response, safety and durability of benefit, while maintaining the precision control over onset, depth and duration it says differentiates TRP-8803 from oral psilocybin therapies.
Results from both cohorts are anticipated through the Q1–Q2 2026 period, and are expected to inform subsequent trial design, regulatory engagement and broader development of TRP-8803 across eating disorders and other neuropsychiatric indications.