Key facts
- Company
- Entropy Neurodynamics Limited (ASX: ENP)
- Trial phase
- Phase 1b/2a
- Participants
- 72
- Indications
- Eight disorders
- First dosing
- Expected later this quarter
- Cost
- Approximately A$3.2 million
Background
Entropy Neurodynamics Limited (ASX: ENP), a clinical-stage biotechnology company developing precision-controlled psychedelic therapies, has received Human Research Ethics Committee (HREC) approval to commence a Phase 1b/2a multi-indication basket study evaluating TRP-8803 (IV-infused psilocin) across eight significant and widespread disorders.
The company has also entered into a Clinical Trial Research Agreement (CTRA) with Swinburne University to conduct this world-first trial initiative. The study builds on encouraging Phase 2 results in Binge Eating Disorder, which delivered a 100% clinical response and 50% remission.
TRP-8803 is Entropy's proprietary intravenously administered psilocin formulation. Psilocin is the active metabolite of psilocybin and the compound responsible for the therapeutic and psychoactive effects traditionally associated with psilocybin. TRP-8803 is administered in conjunction with psychotherapy.
Current situation
The approved Phase 1b/2a open-label study will evaluate the safety, tolerability and preliminary efficacy of TRP-8803 across eight disorders with significant unmet medical need and shared underlying features, including cognitive inflexibility, emotional distress and persistent bodily symptoms.
The study is expected to enrol 72 participants across nine clinical cohorts of eight participants each. The Treatment-Resistant Major Depressive Disorder (TRD) arm includes two separate cohorts: patients receiving stable antidepressant therapy (SSRI or other antidepressant) and patients not receiving antidepressant treatment.
The eight indications being evaluated are: Treatment Resistant Major Depressive Disorder, Anorexia Nervosa, Body Dysmorphic Disorder, Obsessive Compulsive Disorder, Generalised Anxiety Disorder, Post Traumatic Stress Disorder, Fibromyalgia and Irritable Bowel Syndrome. Participants will receive two doses of TRP-8803, administered approximately two weeks apart, alongside a structured psychedelic-assisted psychotherapy program.
| Parameter | Detail |
|---|---|
| Trial phase | Phase 1b/2a |
| Participants | 72 |
| Cohorts | Nine |
| Indications | Eight |
| Dosing | Two doses, two weeks apart |
| Primary endpoint | Safety |
| Cost | Approximately A$3.2 million |
Impacts
The basket study is designed to assess TRP-8803 across multiple indications within one clinical framework, helping the Company prioritise future development opportunities while strengthening the clinical evidence base for its proprietary intravenous psilocin platform.
The study will expand the clinical safety database for TRP-8803 across multiple patient populations and further differentiate Entropy's precision-controlled intravenous platform from oral psychedelic therapies. Together, these outcomes are expected to create future clinical, commercial and partnering opportunities while further validating TRP-8803 as a scalable precision treatment platform.
The concurrent CTRA with Swinburne University materially strengthens Entropy's clinical development capability by expanding the operational infrastructure available for the basket study and future clinical programs. This enhanced capability is expected to improve patient throughput, support faster recruitment and dosing across the basket study, and provide a scalable clinical research platform for future expansion of the Company's development pipeline.
Future outlook
Scenario analysis: The possibilities below are not certain predictions.
Following HREC approval, the Company will complete the remaining regulatory and site governance requirements needed to commence the study, including Clinical Trial Notification (CTN) acknowledgement and site-specific governance approvals. Patient recruitment will commence shortly, reflecting significant preparation ahead of HREC approval.
First patient dosing is expected to commence during the current quarter and, subject to recruitment and operational timelines, the Company anticipates completing dosing in one or more indication cohorts before the end of CY2026. The basket study could generate several meaningful clinical milestones over the coming months as recruitment progresses across the eight indications.
If the study meets its recruitment and dosing timelines, Entropy could deliver multiple clinical milestones and further establish TRP-8803 as a differentiated precision-controlled psychedelic therapy. However, if recruitment or operational timelines are delayed, dosing completion in some cohorts may slip beyond CY2026. The Company believes the strengthened partnership positions Entropy to execute increasingly complex clinical programs efficiently while continuing to build one of Australia's leading psychedelic clinical research collaborations.
Source: vietnamtribune.com
