Entropy Neurodynamics Reports Durable 12-Week Response With TRP-8803 in Treatment-Resistant Binge Eating Disorder
核心洞察
Entropy Neurodynamics (搜索) reported 12-week follow-up data from Cohort 1 of its Phase 2 trial of IV-infused psilocin TRP-8803 in treatment-resistant binge eating disorder (搜索).
Half of patients had no binge eating episodes across the full 84-day follow-up, with weekly episodes remaining 73% below baseline at 12 weeks.
Anxiety fell 50%, depression 42%, quality of life improved 61% and clinician-rated global impression scores improved 44% at 12 weeks.
Entropy Neurodynamics (搜索) (ASX: ENP) has reported positive 12-week follow-up results from Cohort 1 of its Phase 2 trial of TRP-8803, an intravenously infused psilocin, in treatment-resistant binge eating disorder (搜索) (BED). The trial is being conducted in collaboration with Melbourne's Swinburne University of Technology.
The data show a durable clinical response after just two doses of TRP-8803, 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, essentially maintaining the 74% reduction previously reported at the four-week mark.
Sustained Benefit Across Secondary Measures
Additional therapeutic benefits were also maintained at 12 weeks, including a 50% reduction in anxiety, a 42% reduction in depression, a 61% improvement in quality of life, and a 44% improvement in clinician-rated clinical global impression scores.
Entropy characterized the durability of response as notable given the chronic and treatment-resistant profile of Cohort 1. Patients had lived with BED for an average of 15 years, had previously failed at least one BED treatment, and entered the trial averaging 2.3 binge eating episodes per week.
Reproducible Psychedelic State and EEG Changes
TRP-8803 produced what the company described as 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 (EEG) 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.
According to Entropy, the 12-week follow-up adds a durability component to these findings, with substantial clinical improvement in BED symptoms remaining evident from both patient-reported and clinician-rated perspectives well beyond completion of TRP-8803 treatment. Taken together, the four- and 12-week findings for Cohort 1 indicate that TRP-8803 produces not only a powerful and reproducible psychedelic state, but also reproducible changes in brain dynamics and substantial clinical improvement that remained durable at 12 weeks.
Durability as a Core Trial Endpoint
Entropy chief executive officer Jason Carroll said durability was a key endpoint 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.
Carroll linked the findings to the regulatory environment, noting that the US Food and Drug Administration (搜索)'s recently finalized guidance for psychedelic drug development identifies 12 weeks as an important efficacy assessment period for chronic psychiatric conditions.
"The US Food and Drug Administration (搜索)'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," he said.
"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."
Next Steps in the BED Program
Entropy is now focused on Cohort 2, in which patients will receive a shorter TRP-8803 infusion regimen intended to further optimize treatment efficiency and clinical scalability. Results from Cohort 2 are due before year end and are expected to provide the next major clinical catalyst for the BED program.