Australian biotechnology company Entropy Neurodynamics (ASX: ENP) has reported encouraging topline results from the first cohort of its Phase 2 clinical trial evaluating TRP-8803, an intravenously infused psilocin therapy, in patients with treatment-resistant binge eating disorder (BED).
According to the company, 50% of participants achieved complete clinical remission four weeks after treatment, while every patient in the study recorded a clinically meaningful improvement in symptoms. The results represent what Entropy believes to be the first reported clinical efficacy data for precision-controlled IV-infused psilocin, marking an important milestone in the development of next-generation psychedelic therapies.
Strong Early Efficacy Signal
Cohort 1 enrolled six patients with treatment-resistant binge eating disorder, a condition characterised by recurrent episodes of uncontrolled eating that often persists despite conventional treatment.
Three of the six participants reported no binge-eating episodes during the four weeks following treatment, meeting the study’s definition of complete clinical remission. The remaining participants all achieved clinically meaningful improvements, defined by the company as at least a 30% improvement from baseline symptom scores.
Beyond improvements in binge-eating behaviour, participants experienced broad gains across several psychiatric measures. Weekly binge-eating episodes were reduced by 74%, while anxiety and depression scores each declined by approximately 58%. Quality of life also improved substantially, with life satisfaction increasing by 63% across the cohort.
Although the findings are based on a small early-stage study, the consistency of the responses across all participants provides an encouraging efficacy signal that now requires confirmation in larger patient groups.
A Different Approach to Psychedelic Therapy
Unlike most clinical psychedelic programmes that administer oral psilocybin, Entropy’s TRP-8803 delivers psilocin—the active metabolite of psilocybin—directly via intravenous infusion.
The company says this approach offers greater control over the psychedelic experience, allowing clinicians to achieve rapid onset, predictable treatment intensity and a controlled offset while retaining the ability to adjust or stop the infusion if clinically required. Entropy argues these characteristics may address several practical limitations associated with oral psilocybin, including variable absorption, prolonged treatment sessions and limited dose flexibility once administered.
Median time to peak treatment intensity was approximately 20 minutes, with the company reporting consistently predictable therapeutic experiences across participants.
As the psychedelic medicine sector increasingly focuses on developing therapies that can be integrated into mainstream healthcare systems, approaches that reduce treatment time and improve dosing precision are attracting growing interest from researchers and investors alike.
Safety Profile Supports Progression
Entropy also reported a favourable safety profile for TRP-8803 during Cohort 1.
The company said there were no serious adverse reactions, no suspected unexpected serious adverse reactions (SUSARs) and no treatment discontinuations due to safety events. Most adverse reactions were classified as mild or moderate, while one Grade 3 event was managed according to protocol.
Following a review of the safety data, the independent Data Safety Monitoring Board (DSMB) recommended the trial proceed to Cohort 2 without any changes to the planned 60-minute infusion protocol, providing additional support for the treatment’s operational feasibility.
Platform Potential Beyond Binge Eating Disorder
While the current study is focused on binge eating disorder, Entropy views TRP-8803 as a broader precision-controlled psychedelic platform that could be evaluated across multiple neuropsychiatric disorders.
The company is also investigating electroencephalography (EEG) biomarkers that may eventually help quantify psychedelic brain states, optimise dosing and identify patients most likely to benefit from treatment, although these approaches remain under development and have not yet been clinically validated.
If future studies confirm the early findings, IV-infused psilocin could represent an alternative delivery model within psychedelic medicine, particularly for indications where treatment efficiency, reproducibility and clinician control are considered important.
Next Steps
Entropy said Cohort 2 has been fully enrolled, with baseline assessments expected to commence this quarter and dosing scheduled to begin using the DSMB-endorsed 60-minute infusion regimen. Final Phase 2 results are anticipated in the fourth quarter of 2026.
While the current data remain preliminary and are derived from a small patient cohort, the results provide an early indication that precision-controlled IV psilocin may warrant further investigation as a potential treatment for binge eating disorder and other psychiatric conditions.
