Entropy’s TRP-8803 Response Holds After 12 Weeks in BED Trial
Entropy Neurodynamics reported that all six patients in Cohort 1 of its Phase 2 BED trial maintained clinically meaningful improvement 12 weeks after two TRP-8803 infusions. Three patients experienced no binge-eating episodes during the 84-day follow-up, although the results come from a small, open-label study without a control group.
- 100% of patients maintained clinically meaningful improvement
- 50% achieved full remission over 12 weeks
- Weekly binge-eating episodes remained 73% below baseline
- Two IV psilocin treatments produced sustained response
- Shorter-infusion Cohort 2 data due in Q4 2026
Six Patients Retain BED Improvement After Two Infusions
Entropy Neurodynamics Limited (ASX:ENP) has produced the kind of follow-up data psychedelic developers need but rarely get to headline: the initial response did not materially fade over three months. All six treatment-resistant Binge Eating Disorder patients in Cohort 1 maintained clinically meaningful improvement 12 weeks after completing two TRP-8803 infusions, while three reported no binge-eating episodes across the full 84-day period.
Weekly binge-eating episodes remained 73% below the cohort's pretreatment baseline at week 12, only slightly below the 74% reduction recorded at week four. The patients had entered the study averaging 2.3 episodes a week, had lived with BED for between two and 20 years, and each had previously failed at least one treatment.
Secondary Measures Show Sustained, Uneven Gains
The follow-up was not limited to the primary BED measure. Anxiety was 50% lower than baseline at 12 weeks, depression was down 42%, life satisfaction had improved 61% and clinician-rated Clinical Global Impression scores had improved 44%. Compared with week four, anxiety and depression gains had eased, while clinician-rated improvement increased from 33% to 44%.
That pattern is encouraging but not uniform, and the company’s own framing matters. These are early results from six patients in a small, open-label study with no control or comparative group. They show persistence within this cohort; they do not establish the treatment effect in a broader BED population, determine long-term safety, or settle how often patients might eventually need retreatment.
TRP-8803 Combines Strong Psychedelic Exposure With Brain Data
TRP-8803 is an intravenous formulation of psilocin, the active metabolite of psilocybin. Across Cohort 1, nine of 12 treatment sessions reached the maximum reported psychedelic intensity of 10 out of 10, with a mean peak intensity of 9.4 out of 10. Independent preliminary EEG analysis also identified increased EEG complexity and substantial reductions in alpha activity after both treatment sessions.
Entropy says the EEG and biomarker work will continue to examine the relationship between drug exposure, brain dynamics and clinical outcomes. The company is also pointing to finalised 2026 FDA guidance that identifies durability, including week-12 assessment for chronic psychiatric conditions such as major depressive disorder and PTSD, as relevant to psychedelic drug development. That is regulatory alignment, not FDA review or endorsement of these BED results.
Cohort 2 Tests Whether Shorter Treatment Can Hold Up
The next test is practical as much as clinical. Cohort 2 will assess two 60-minute infusions, compared with two 140-minute infusions in Cohort 1, with results expected in the fourth quarter of calendar 2026. The question is whether a shorter regimen can preserve an appropriate psychedelic experience and clinical response while making treatment more efficient to deliver.
The BED work sits within Entropy’s planned 72-patient, eight-indication Australian program, alongside its proposed US Phase 2 major depressive disorder study with UCSF. BED results cannot be assumed to translate to depression, but the upcoming shorter-infusion data should provide a more pointed read on whether TRP-8803’s controlled delivery model can move beyond a promising small cohort toward a scalable clinical proposition.
Bottom Line?
The 12-week signal is unusually durable for such a small cohort, but Cohort 2 must show that the response survives a shorter and potentially more scalable treatment schedule.
Questions in the middle?
- Will the 73% reduction in binge-eating episodes persist in a larger or controlled study?
- Can the 60-minute infusion regimen retain the depth and consistency of the psychedelic response?
- Will longer follow-up reveal when, or whether, retreatment becomes necessary?