Entropy Neurodynamics Completes Cohort 1 Dosing in Phase 2 BED Trial
Entropy Neurodynamics completes Cohort 1 dosing in Phase 2 BED trial
Entropy Neurodynamics (ASX: ENP) has completed dosing of all six participants in Cohort 1 of its Phase 2 clinical study evaluating TRP-8803 (IV-infused psilocin) for Binge Eating Disorder (BED). All participants successfully received both administrations of the compound, delivered 14 days apart in conjunction with supportive therapy, achieving a controlled and reproducible psychedelic response across the cohort.
The trial, conducted in collaboration with Swinburne University, targets enrolment of 12 patients across two cohorts of six participants each. Cohort 1 received a mid-range therapeutic dose, while the dosing regimen for Cohort 2 will be determined following review of Cohort 1 outcomes.
Topline efficacy results from Cohort 1 are expected in July 2026, representing the next major catalyst for the clinical programme.
The controlled and reproducible response achieved across all Cohort 1 participants supports the company’s thesis that IV-infused psilocin offers distinct advantages over conventional oral psychedelic therapies. These observations position the TRP-8803 platform as a potentially differentiated approach to psychedelic-assisted treatment.
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What is IV-infused psilocin and why does it matter?
Psilocin is the active metabolite of psilocybin, the compound responsible for the psychedelic effects observed in therapeutic trials. When psilocybin is consumed orally, the body converts it into psilocin, which then produces the therapeutic response.
Entropy’s TRP-8803 delivers psilocin directly via intravenous infusion, bypassing the oral conversion process entirely. This delivery method is positioned to address several limitations associated with oral psilocybin therapies.
The company has identified five stated advantages of the IV-infused approach:
- Rapid onset: Treatment begins quickly following administration
- Predictable pharmacokinetics: Consistent drug behaviour across patients
- Precise control: Ability to modulate treatment intensity and duration in real-time
- Rapid reversibility: Treatment can be halted if needed
- Shorter treatment sessions: Reduced clinic time compared to oral protocols
These advantages have material implications for commercial viability. Shorter, more predictable treatment sessions reduce clinic costs, improve patient throughput, and enhance the scalability of psychedelic-assisted therapy in real-world clinical settings. The ability to control treatment intensity and duration also addresses a key barrier to broader adoption of psychedelic medicine: variability in patient response.
Trial progression and next steps
Following completion of Cohort 1 dosing, the study protocol will undergo review by the Data and Safety Monitoring Board (DSMB) prior to commencement of Cohort 2 dosing. This review is expected to be completed in the coming weeks and coincides with final patient enrolment initiatives.
Cohort 2 enrolment is already well advanced. Five of the six participants have been enrolled, with the sixth currently in the final interview stage. This near-complete enrolment positions the company to maintain trial momentum following DSMB clearance.
The dosing regimen for Cohort 2 has not yet been finalised and will be determined following review of Cohort 1 outcomes. Cohort 1 received a mid-range therapeutic dose, providing a reference point for potential dose optimisation in the second cohort.
The trial progression timeline follows this sequence:
- Cohort 1 dosing complete (current milestone)
- DSMB review (coming weeks)
- Cohort 2 dosing (pending DSMB clearance)
- Topline results (July 2026)
The July data readout represents the next major inflection point for the programme, providing the first efficacy signals from the TRP-8803 platform in BED patients.
CEO commentary
Chief Executive Officer Jason Carroll positioned the Cohort 1 completion as clinical validation of the TRP-8803 delivery platform:
Jason Carroll, CEO
“Completing dosing in Cohort 1 is an important milestone for Entropy and keeps us firmly on track to deliver topline results in early July. Given that all patients achieved a controlled and reproducible response to treatment and all at with a high intensity, we are very confident that topline will highlight positive clinical outcomes for BED patients.”
Carroll emphasised the commercial implications of treatment consistency:
“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.”
He also noted that Cohort 1 data will inform optimisation of the second dosing cohort, providing insights into the future development pathway for TRP-8803.
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Investment case for TRP-8803 platform
The completion of Cohort 1 dosing represents clinical execution de-risking for the TRP-8803 delivery platform. The achievement of controlled and reproducible psychedelic responses across all participants validates the core premise of the IV-infused approach: that direct psilocin administration can deliver consistent outcomes with precise control.
This is not Entropy’s first exposure to psychedelic therapy development. The company has previously conducted Phase 2a clinical trials using oral psilocybin across three indications: Binge Eating Disorder, Irritable Bowel Syndrome, and Fibromyalgia. Results from these trials demonstrated clinical benefits and informed the development strategy for TRP-8803.
The IV-infused platform approach creates optionality beyond BED alone. If the July topline results validate efficacy alongside the established safety and consistency profile, the TRP-8803 delivery technology could be applied across Entropy’s broader pipeline, addressing multiple indications with a single platform.
Near-term catalysts:
- DSMB review (coming weeks): Safety clearance enables Cohort 2 progression
- Topline Cohort 1 results (July 2026): First efficacy signals from TRP-8803 platform
- Cohort 2 initiation (post-DSMB): Potential dose optimisation based on Cohort 1 learnings
The July data readout will determine whether the controlled response profile observed in Cohort 1 translates into meaningful clinical outcomes for BED patients. A positive result would validate the commercial thesis that IV-infused psilocin offers a differentiated, scalable approach to psychedelic-assisted therapy.
Ready to Learn More About TRP-8803’s Clinical Progress?
Entropy Neurodynamics has achieved a significant milestone with the successful completion of Cohort 1 dosing, demonstrating controlled and reproducible psychedelic responses across all participants. This validates the core premise of the IV-infused psilocin delivery platform.
With topline efficacy results expected in July 2026, investors seeking deeper insights into the company’s clinical strategy and commercial pathway can visit the Entropy Neurodynamics investor centre. The platform approach creates optionality across multiple indications beyond BED alone.