- 01Two TRP-8803 infusions yield durable BED response.
- 0250% no binges; 84d; 12-wk binge rate 73% below baseline.
- 03Anxiety -50%, Depression -42%, QoL +61%, CGI +44%.
Entropy Neurodynamics (ASX: ENP) has released positive results from a 12-week follow-up on Cohort 1 of the Phase 2 trial of TRP-8803 IV-infused psilocin for treatment-resistant binge eating disorder (BED) it is conducting in collaboration with Melbourne’s Swinburne University of Technology.
The results demonstrated a durable clinical response following two doses of TRP-8803 treatment, with 50% of patients experiencing no binge eating episodes throughout the entire 84-day follow-up period.
Across the cohort, weekly binge eating episodes remained 73% below pre-treatment baseline at 12 weeks, maintaining the 74% reduction previously reported at the four-week mark.
Additional therapeutic benefits were maintained, including a 50% reduction in anxiety, 42% reduction in depression, 61% improvement in quality of life, and 44% improvement in clinician-rated clinical global impression scores.
Entropy said the durability of response was notable given the chronic and treatment-resistant nature of Cohort 1 patients who had lived with BED for an average 15 years, had previously failed at least one BED treatment, and entered the trial averaging 2.3 binge eating episodes per week.
Powerful and Reproducible Results
TRP-8803 is reported to have produced a powerful and reproducible psychedelic state across Cohort 1, with nine of 12 treatment sessions reaching 10/10 intensity and a mean peak intensity of 9.4/10.
Independent preliminary electroencephalography analysis identified large and reproducible changes in patient brain dynamics following IV administration including increased EEG complexity and substantial reductions in alpha activity across both treatment sessions.
The 12-week follow-up added an important durability component to these findings, with substantial clinical improvement in BED symptoms remaining evident from patient-reported and clinician-rated perspectives well beyond completion of TRP-8803 treatment.
Together, the four and 12-week findings for Cohort 1 demonstrated that TRP-8803 produces not just a powerful and reproducible psychedelic state, but also reproducible changes in brain dynamics and substantial clinical improvement that remained durable at 12 weeks.
Key Durability End-Point
Entropy chief executive officer Jason Carroll said TRP-8803’s durability was a key end-point of the trial.
“We are not seeking to develop another medicine that patients need to take every day, rather we are investigating whether a limited number of precision-controlled psychedelic treatments can produce a clinically meaningful benefit that persists long after dosing has finished,” he said.
“The US Food and Drug Administration’s recently finalised guidance for psychedelic drug development identifies 12 weeks as an important efficacy assessment period for chronic psychiatric conditions—our BED program has independently generated 12-week follow-up data showing the clinical response after two TRP-8803 infusions was substantially maintained and that the regulatory direction and clinical evidence we are generating are increasingly aligned.
“We believe these results provide increasing clinical validation of our precision-controlled approach and materially strengthen the clinical rationale for continued development of TRP-8803.”
Entropy is now focused on Cohort 2, in which patients will be subject to a shorter TRP-8803 infusion regimen to further optimise treatment efficiency and clinical scalability, with results due before year end and expected to provide the next major clinical catalyst for the BED program.
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