Entropy Neurodynamics Completes First Cohort Dosing in Phase 2 BED Trial
Entropy Neurodynamics completes first cohort dosing in Phase 2 BED trial
Entropy Neurodynamics (ASX: ENP) has announced completion of dosing for all six participants in Cohort 1 of its Phase 2 clinical trial evaluating TRP-8803 in patients with Binge Eating Disorder. Each participant received two administrations of the IV-infused psilocin therapy delivered 14 days apart in conjunction with supportive therapy, achieving a controlled and reproducible psychedelic response across all participants. Topline efficacy results from Cohort 1 are expected in July 2026.
The study, conducted in collaboration with Swinburne University, is targeting enrolment of 12 patients across two cohorts. Cohort 1 received a mid-range therapeutic dose, while the dosing regimen for Cohort 2 will be determined following review of Cohort 1 outcomes. All six Cohort 1 participants successfully completed dosing, with the Data Safety and Monitoring Board scheduled to meet in the coming weeks to assess safety data before Cohort 2 dosing can commence.
When big ASX news breaks, our subscribers know first
Why IV-infused psilocin differs from oral psychedelic therapies
TRP-8803 is an IV-infused formulation of psilocin, the active metabolite of psilocybin. The Company’s development thesis centres on the potential advantages IV delivery offers over conventional oral psilocybin therapies currently under investigation by competitors.
The claimed benefits of the IV-infused approach include:
- Rapid onset of psychedelic state
- Predictable pharmacokinetics
- Precise control over treatment intensity and duration
- Rapid treatment reversibility
- Potential for shorter, commercially viable treatment sessions
Clinical observations from Cohort 1 support this differentiation thesis. All participants achieved a controlled and reproducible psychedelic response, suggesting the delivery mechanism may enable more consistent therapeutic outcomes across patient populations. If validated in subsequent cohorts, this differentiation could offer commercial advantages in scalability and real-world clinical integration compared to oral psilocybin platforms.
The IV psilocin platform has already generated a 75% response rate in treatment-resistant IBS patients in a separate Phase 2a trial, a result researchers from Massachusetts General Hospital and Columbia University described as the strongest clinical signal ever recorded in IBS drug development, lending additional weight to the BED programme’s commercial thesis.
Cohort 2 recruitment nears completion ahead of safety review
The Data Safety and Monitoring Board will meet in the coming weeks to assess Cohort 1 safety data before Cohort 2 dosing can commence. Five of the six Cohort 2 participants have been enrolled, with the sixth participant in final interview stage. The near-complete enrolment status minimises delay risk following DSMB clearance.
The dosing regimen for Cohort 2 will be determined after review of Cohort 1 outcomes. This protocol-specified flexibility allows the Company to optimise the therapeutic dose based on the emerging clinical data, potentially improving efficacy outcomes in the second cohort.
Trial milestones and upcoming catalysts
Entropy Neurodynamics BED Trial Progress is now entering a catalyst-dense phase concentrated in Q1 FY27:
- DSMB safety review (coming weeks)
- Topline Cohort 1 efficacy results (July 2026)
- Cohort 2 dosing commencement (post-DSMB clearance)
- Cohort 1 data to inform Cohort 2 dose optimisation
The Cohort 1 data readout will shape the future development pathway for TRP-8803, potentially informing dose selection for subsequent trials across the Company’s broader pipeline, which includes programmes in Irritable Bowel Syndrome and Fibromyalgia.
CEO outlines path to real-world clinical integration
Jason Carroll, Chief Executive Officer
“Delivering a predictable and controllable psychedelic experience is an important step towards developing a therapy that can be integrated into real-world clinical settings, where treatment efficiency, reproducibility and scalability will be key drivers of commercial success.”
Mr Carroll noted his confidence that topline results will highlight positive clinical outcomes for BED patients, given that all Cohort 1 participants achieved a controlled response at high intensity. The CEO’s commentary positions TRP-8803 as a platform designed for commercial scalability, not just clinical proof-of-concept, emphasising treatment efficiency and reproducibility as differentiators.
Key trial metrics at a glance
| Parameter | Cohort 1 | Cohort 2 | Total Trial |
|---|---|---|---|
| Participants | 6 | 6 | 12 |
| Dosing sessions per patient | 2 | 2 | 2 |
| Dose level | Mid-range | TBD post-review | — |
| Enrolment status | Complete | 5 of 6 enrolled | 11 of 12 enrolled |
| Topline results | July 2026 | TBD | — |
The next major ASX story will hit our subscribers first
What investors should watch for next
The July 2026 topline readout represents a binary catalyst for Entropy Neurodynamics. Positive Cohort 1 data would validate the IV-psilocin differentiation thesis and support progression to Cohort 2, de-risking the broader TRP-8803 platform across multiple indications. The Company’s parallel programmes in Irritable Bowel Syndrome and Fibromyalgia could benefit from any dose-optimisation insights generated in the BED trial, potentially accelerating development timelines across the pipeline.
Early post-treatment assessments from the first enrolled patient, reported in April 2026, showed clinically meaningful reductions in binge eating severity, anxiety, and depression that exceeded investigator expectations, providing an encouraging signal ahead of the formal July topline readout.
With 11 of 12 participants now enrolled and the DSMB review expected in the coming weeks, the trial remains on track per company guidance. The concentrated catalyst timeline through Q1 FY27 positions Entropy Neurodynamics for multiple value inflection points over the next three months.
Get Healthcare Biotech Alerts Before the Market Moves
Join 20,000+ investors receiving FREE breaking ASX healthcare news within minutes of release, complete with in-depth analysis. Click the “Free Alerts” button at Big News Blast to start getting market-moving biotech announcements delivered straight to your inbox the moment they break.