Announcement • 18h
Entropy Neurodynamics Limited Receives Approval to Commence Phase 1B/2A Multi-Indication Basket Study Evaluating Trp-8803
Entropy Neurodynamics Limited has received Human Research Ethics Committee 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 with Swinburne University to conduct this world-first trial initiative. 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 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 arm includes two separate cohorts: patients receiving stable antidepressant therapy and patients not receiving antidepressant treatment. This design will allow the Company to assess TRP-8803's safety and clinical activity across distinct Treatment-Resistant Major Depressive Disorder treatment settings, while generating indication-specific efficacy signals to guide future development priorities. The eight indications being evaluated are Anorexia Nervosa, Fibromyalgia (chronic pain), Irritable Bowel Syndrome, Obsessive Compulsive Disorder, Body Dysmorphic Disorder, Generalised Anxiety Disorder, Post Traumatic Stress Disorder, and Treatment Resistant Major Depressive Disorder. Participants will receive two doses of TRP-8803, administered approximately two weeks apart, alongside a structured psychedelic-assisted psychotherapy program. The primary endpoint is safety. Secondary and exploratory endpoints will assess changes in anxiety, quality of life, disease-specific symptoms and broader patient-reported outcomes. The protocol also includes advanced biomarker assessments, including MRI, functional MRI, electroencephalography, speech analysis and qualitative patient interviews, to further characterise TRP-8803's biological and clinical effects across multiple indications. The basket trial allows Entropy to assess the broader therapeutic potential of its proprietary intravenous psilocin platform across multiple disorders in parallel, providing a capital-efficient way to identify the strongest clinical and commercial opportunities for future development. The basket study marks a world-first initiative in neuropsychiatry and an important strategic milestone in the development of TRP-8803. The study builds on highly encouraging clinical outcomes in Binge Eating Disorder, where the first patient cohort achieved a 100% clinical response, 50% remission and significant improvements in anxiety and depression. The selected indications represent areas of substantial unmet medical need, with many sharing a common neurobiological mechanism that may respond to precision-controlled psychedelic therapy. They were chosen based on growing scientific and clinical evidence supporting the therapeutic potential of psychedelics across these disorders, providing a strong basis to evaluate TRP-8803 in high-priority development opportunities. By assessing multiple disorders within one clinical program, Entropy aims to efficiently identify the indications with the strongest clinical and commercial potential, helping the Company prioritise future development and capital allocation. The study will also 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. The concurrent Clinical Trial Research Agreement with Swinburne University also materially strengthens Entropy's clinical development capability by expanding the operational infrastructure available for the basket study and future clinical programs. The agreement provides access to additional clinical infrastructure, including greater dosing capacity through multiple dedicated treatment rooms, an expanded multidisciplinary team of investigators, psychiatrists, physicians, psychologists and psychedelic therapists, and enhanced research and operational support to help deliver multiple study cohorts in parallel. 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. Following Human Research Ethics Committee approval, the Company will complete the remaining regulatory and site governance requirements needed to commence the study, including Clinical Trial Notification acknowledgement and site-specific governance approvals. Patient recruitment will commence shortly, reflecting significant preparation ahead of Human Research Ethics Committee approval and positioning the Company to rapidly advance the study into treatment. 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 calendar year 2026. Entropy believes the basket study could generate several meaningful clinical milestones over the coming months as recruitment progresses across the eight indications. 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. TRP-8803 delivers psilocin directly into the bloodstream, avoiding the need for gastrointestinal absorption and conversion of psilocybin into psilocin. This may reduce pharmacokinetic variability, improve dosing precision, shorten treatment duration, and allow clinicians to adjust or cease dosing if required. IV administration allows clinicians to rapidly achieve and maintain the desired target psilocin blood level and improve the consistency of exposure and therapeutic intensity between patients. It also enables real-time control over duration and intensity of treatment.