Entropy Neurodynamics has received Human Research Ethics Committee approval to begin a Phase 1b/2a basket study of TRP-8803, its proprietary intravenous psilocin formulation.
The Melbourne-based company said it will evaluate the treatment across eight disorders in what it describes as a world-first multi-indication trial.
The study will enrol 72 participants across nine clinical cohorts. The conditions being assessed are anorexia nervosa, body dysmorphic disorder, obsessive-compulsive disorder, generalised anxiety disorder, post-traumatic stress disorder, treatment-resistant major depressive disorder, fibromyalgia and irritable bowel syndrome.
Treatment-resistant depression will be examined in two separate cohorts. One will include patients receiving stable antidepressant therapy, including selective serotonin reuptake inhibitors, while the other will involve patients who are not taking antidepressants.
Entropy has also entered into a Clinical Trial Research Agreement with Swinburne University. The expanded partnership will provide additional dosing capacity, dedicated treatment rooms and a multidisciplinary team of investigators, psychiatrists, physicians, psychologists and psychedelic therapists.
CEO Jason Carroll said, “Securing HREC approval and executing our expanded Clinical Trial Research Agreement with Swinburne University represents a significant milestone in the evolution of TRP-8803 from a promising lead asset into a scalable precision treatment platform capable of addressing multiple high-value neuropsychiatric disorders.”
He said the basket design would allow the company to assess several potential treatment areas at the same time rather than pursuing each indication separately.
“Following the highly encouraging clinical outcomes generated in treatment-resistant Binge Eating Disorder, we now can systematically evaluate TRP-8803 across eight additional disorders that share common underlying mechanisms. Rather than pursuing these indications sequentially, our world-first basket study enables us to evaluate them in parallel, significantly accelerating our understanding of where TRP-8803 has the greatest clinical and commercial potential.”
Participants will receive two doses of TRP-8803 approximately two weeks apart, alongside a structured psychedelic-assisted psychotherapy program. The study’s primary endpoint will be safety, while secondary and exploratory measures will assess anxiety, quality of life, disease-specific symptoms and broader patient-reported outcomes.
Researchers will also collect data from magnetic resonance imaging, functional magnetic resonance imaging, electroencephalography, speech analysis and qualitative patient interviews. The assessments are intended to help the company understand how the treatment affects brain activity, cognitive flexibility and patient wellbeing across different disorders.
TRP-8803 delivers psilocin directly into the bloodstream. Psilocin is the active metabolite of psilocybin and is responsible for the compound’s therapeutic and psychoactive effects. Entropy says intravenous administration may provide more precise control over dosing, treatment intensity and treatment duration than oral psilocybin. The infusion can also be paused or stopped if clinically required.
The company’s strategy is based on the possibility that several of the disorders share underlying features such as cognitive inflexibility, emotional distress and persistent bodily symptoms. Entropy is investigating whether changes in neural entropy, brain network function and cognitive flexibility may be associated with clinical improvements across different conditions.
The study builds on results from an earlier Phase 2 trial in treatment-resistant binge eating disorder. Entropy reported that the first patient cohort achieved a 100 per cent clinical response rate and 50 per cent remission rate, along with significant improvements in anxiety and depression.
The basket study is expected to cost approximately $3.2 million, excluding potential research and development tax incentive refunds. By testing multiple indications within one clinical framework, the company aims to identify the strongest development opportunities while reducing the cost and time associated with running separate trials.
Mr Carroll added, “Importantly, our expanded partnership with Swinburne provides the clinical infrastructure, specialist expertise and operational capacity required to efficiently execute a study of this scale. With first dosing expected later this quarter, we believe Entropy is entering one of the most active and value-generating periods in the Company's history, with the potential to deliver multiple clinical milestones and further establish TRP-8803 as a differentiated precision-controlled psychedelic therapy.”
Patient recruitment is expected to begin shortly, subject to the completion of remaining regulatory and site governance requirements. Entropy expects first patient dosing later in the current quarter and anticipates dosing in one or more initial cohorts before the end of calendar year 2026.
