Entropy Completes First Cohort Dosing in Binge Eating Trial Ahead of 2026 Data
Entropy Neurodynamics hits key milestone in BED trial as all Cohort 1 patients complete dosing
Entropy Neurodynamics has announced the completion of dosing for all six participants in Cohort 1 of its Phase 2 trial evaluating TRP-8803 for Binge Eating Disorder. Each participant received two administrations of the IV-infused psilocin formulation 14 days apart, alongside supportive therapy. The trial targets 12 patients across two cohorts, with topline efficacy results for Cohort 1 expected in July 2026.
The announcement highlights a standout clinical observation: all Cohort 1 participants achieved a controlled and reproducible psychedelic response at high intensity. This consistency supports the company’s thesis that IV-infused psilocin may offer significant advantages over conventional oral psychedelic therapies. The trial is being conducted in collaboration with Swinburne University and is designed to evaluate the safety and feasibility of TRP-8803 whilst generating insights into treatment optimisation.
Management stated they are “very confident” the July data will highlight positive clinical outcomes for BED patients. Completing dosing without reported safety issues de-risks the next stage of the trial and positions the company for a near-term data catalyst.
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Why IV-infused psilocin matters for psychedelic medicine
TRP-8803 is a proprietary IV-infused formulation of psilocin, which is the active metabolite of psilocybin. Whilst oral psilocybin has been studied extensively in psychedelic therapy research, IV delivery allows precise control over the onset, intensity, and duration of the psychedelic experience. This control is critical for integrating psychedelic-assisted therapy into real-world clinical settings where treatment efficiency and reproducibility are essential.
Entropy claims the following advantages for IV-infused psilocin compared to oral therapies:
- Rapid onset of the psychedelic state
- Predictable pharmacokinetics (the way the drug moves through the body)
- Precise control over treatment intensity and duration
- Rapid treatment reversibility if needed
- Potential for shorter, commercially viable treatment sessions
Shorter, more predictable treatment sessions could make psychedelic-assisted therapy scalable in real-world clinical settings, addressing a key commercialisation barrier for the sector. TRP-8803’s controlled duration may reduce this burden whilst maintaining therapeutic efficacy.
Cohort 1 outcomes support the TRP-8803 platform thesis
All Cohort 1 participants achieved a controlled and reproducible response at high intensity. CEO Jason Carroll stated this consistency further supports the differentiated profile of TRP-8803.
Jason Carroll, Chief Executive Officer
“The consistency observed across Cohort 1 further supports the differentiated profile of TRP-8803. 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.”
Reproducibility across all six patients strengthens the case that TRP-8803 can become a standardised treatment protocol. This is essential for regulatory approval, where variability in patient response can complicate efficacy assessments. It also matters for commercial partnerships, as pharmaceutical companies seek assets with clear, predictable clinical profiles that can support broad-label approvals.
Early post-treatment assessments from the first enrolled patient showed clinically meaningful reductions in binge eating severity, anxiety, and depression, exceeding investigator expectations and providing the first signal that the controlled psychedelic response was translating into measurable therapeutic benefit.
What happens next for the BED trial
The Data Safety and Monitoring Board (DSMB) is scheduled to meet in the coming weeks to assess Cohort 1 safety data. This review must be completed before Cohort 2 dosing can commence. Recruitment momentum remains strong: 5 of the 6 participants required for Cohort 2 have already been enrolled, with the sixth in final interview.
Cohort 1 received a mid-range therapeutic dose. The dosing regimen for Cohort 2 will be determined following review of Cohort 1 outcomes, allowing the company to optimise treatment intensity based on the efficacy and safety profile observed.
Key upcoming milestones include:
- DSMB safety review (coming weeks)
- Cohort 2 dosing commencement (post-DSMB approval)
- Topline Cohort 1 efficacy results (July 2026)
The July 2026 data readout represents the next major catalyst. Strong Cohort 2 enrolment reduces execution risk for the second phase of the trial, ensuring the company can move quickly following DSMB clearance.
Entropy’s broader pipeline and development strategy
Entropy has conducted Phase 2a trials using oral psilocybin for three indications: Binge Eating Disorder, Irritable Bowel Syndrome, and Fibromyalgia. Results from these earlier trials demonstrated clinical benefits and are informing TRP-8803 development. The BED trial using TRP-8803 is the lead programme, but positive results could support expansion into other indications where the company has already generated oral psilocybin data.
The oral psilocybin IBS results, which recorded a 75% response rate in treatment-resistant patients compared to 17-44% for approved IBS therapies, represent the clinical foundation that informed the TRP-8803 IV formulation design and help explain why the company sees IBS as a strong candidate for future TRP-8803 trials.
| Indication | Prior Development | Current Status |
|---|---|---|
| Binge Eating Disorder | Phase 2a (oral psilocybin) | Phase 2 (TRP-8803 IV psilocin) |
| Irritable Bowel Syndrome | Phase 2a (oral psilocybin) | Informing TRP-8803 development |
| Fibromyalgia | Phase 2a (oral psilocybin) | Informing TRP-8803 development |
This pipeline structure positions Entropy to leverage its oral psilocybin experience whilst advancing TRP-8803 as a next-generation platform. If TRP-8803 demonstrates consistent, controllable psychedelic responses in BED, the company may pursue additional trials in IBS or fibromyalgia using the IV-infused formulation.
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Investment outlook and upcoming catalysts
Cohort 1 completion is a de-risking event. All six participants achieved the intended psychedelic response without reported safety issues, validating the feasibility of the IV-infusion approach. The July 2026 topline data readout is the next major inflection point for the company.
Management stated they are “very confident” the topline results will highlight positive clinical outcomes for BED patients. If the data supports efficacy alongside the reproducibility already observed, TRP-8803 becomes a differentiated asset in the psychedelic therapy sector. This positions Entropy to pursue partnerships or further development with a clinical profile that addresses key commercialisation barriers: treatment duration, reproducibility, and scalability.
The combination of strong enrolment momentum (Cohort 2 nearly full), consistent Cohort 1 responses, and a near-term data readout creates a defined catalyst window. Investors with exposure to (ASX: ENP) should monitor the DSMB outcome and July efficacy results closely, as these events will determine the pathway for Cohort 2 and the broader TRP-8803 development strategy.
Want to Stay Updated on Entropy’s TRP-8803 Development?
With topline efficacy data from Cohort 1 expected in July 2026 and Cohort 2 nearly fully enrolled, Entropy Neurodynamics is advancing towards key clinical milestones that could validate its differentiated IV-infused psilocin platform. The consistent psychedelic responses observed across all Cohort 1 participants suggest TRP-8803 may address critical commercialisation challenges facing the psychedelic therapy sector.
To track the company’s progress through the DSMB safety review, Cohort 2 dosing, and the upcoming July data catalyst, visit the Entropy Neurodynamics investor centre for the latest announcements and trial updates. Understanding how TRP-8803’s controlled treatment profile compares to conventional oral therapies will be essential for evaluating the commercial opportunity ahead.