Entropy Neurodynamics Secures Ethics Approval for World-First 72-Patient Basket Trial of IV Psilocin Across Eight Neuropsychiatric Indications
核心洞察
Entropy Neurodynamics received HREC approval for a Phase 1b/2a basket study evaluating intravenous psilocin (TRP-8803) across eight major neuropsychiatric and somatic disorders in 72 patients.
The open-label trial will assess safety, tolerability, and preliminary efficacy across anorexia nervosa (搜索), OCD, PTSD, treatment-resistant depression, GAD, body dysmorphic disorder (搜索), fibromyalgia (搜索), and IBS.
The study builds on encouraging Phase 2 Binge Eating Disorder (搜索) results that demonstrated 100% clinical response and 50% remission in the first patient cohort.
Entropy Neurodynamics Limited (搜索) (ASX: ENP), a clinical-stage biotechnology company developing precision-controlled psychedelic therapies, announced on August 4, 2026 that it has received Human Research Ethics Committee (HREC) approval to commence a Phase 1b/2a multi-indication basket study evaluating TRP-8803, its proprietary intravenous psilocin formulation, across eight significant disorders with high unmet treatment needs. The Company has simultaneously executed a Clinical Trial Research Agreement (CTRA) with Swinburne University (搜索) to conduct what it describes as a world-first trial initiative.
CEO Jason Carroll characterized the milestone as "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."
Study Design and Scope
The approved Phase 1b/2a open-label study will enroll 72 participants across nine clinical cohorts of eight participants each. The eight indications under evaluation include Anorexia Nervosa (搜索), Body Dysmorphic Disorder (搜索), Obsessive Compulsive Disorder (搜索), Generalised Anxiety Disorder (搜索), Post Traumatic Stress Disorder (搜索), Treatment-Resistant Major Depressive Disorder (搜索), Fibromyalgia (搜索), and Irritable Bowel Syndrome (搜索).
Notably, the Treatment-Resistant Major Depressive Disorder (搜索) (TRD) arm comprises two separate cohorts: one consisting of patients receiving stable antidepressant therapy (SSRI or other antidepressant) and another of patients not receiving antidepressant treatment. This dual-cohort design enables the Company to assess TRP-8803's safety and clinical activity across distinct TRD treatment settings while generating indication-specific efficacy signals.
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, while secondary and exploratory endpoints will assess changes in anxiety, quality of life, disease-specific symptoms, and broader patient-reported outcomes.
The protocol incorporates advanced biomarker assessments including MRI, functional MRI, electroencephalography (EEG), speech analysis, and qualitative patient interviews to further characterize TRP-8803's biological and clinical effects across multiple indications.
Strategic Rationale and Prior Clinical Data
The basket study builds on highly encouraging clinical outcomes from a Phase 2 Binge Eating Disorder (搜索) trial, where the first patient cohort achieved a 100% clinical response rate, 50% remission, and significant improvements in anxiety and depression, as announced by the Company on July 7, 2026.
The selected indications share common underlying features including cognitive inflexibility, emotional distress, and persistent bodily symptoms. Entropy's transdiagnostic approach focuses on shared mechanisms across multiple disorders rather than treating each diagnosis as entirely separate, investigating whether common processes such as cognitive rigidity, inflexible beliefs, and altered brain network function may respond to TRP-8803-assisted therapy.
Unlike traditional single-indication development programs, the basket trial design allows Entropy to assess the broader therapeutic potential of its proprietary intravenous psilocin platform across multiple disorders in parallel. The Company describes this as a capital-efficient approach to identify the strongest clinical and commercial opportunities for future development.
TRP-8803: Differentiated IV Psilocin Platform
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. The IV route delivers psilocin directly into the bloodstream, bypassing the need for gastrointestinal absorption and conversion of psilocybin into psilocin.
According to the Company, this approach may reduce pharmacokinetic variability, improve dosing precision, shorten treatment duration, and allow clinicians to adjust or cease dosing if clinically required. A key safety advantage is that the infusion can be paused or terminated if clinically necessary, providing a level of control not available with oral administration.
Operational Infrastructure and Partnership
The CTRA with Swinburne University (搜索) materially strengthens Entropy's clinical development capability. 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 deliver multiple study cohorts in parallel.
Financial and Timeline Considerations
The basket study is projected to cost approximately A$3.2 million, excluding the Company's pending R&D Tax Incentive refund opportunities. For this investment, Entropy can evaluate multiple indications, assess biomarkers, refine patient-selection strategies, and identify the strongest future development opportunities — an approach the Company argues would require substantially greater investment if pursued through independent studies across every indication.
Following HREC approval, the Company will complete remaining regulatory and site governance requirements, including Clinical Trial Notification (CTN) acknowledgement and site-specific governance approvals. Patient recruitment will commence shortly, with first patient dosing expected during the current quarter. Subject to recruitment and operational timelines, the Company anticipates completing dosing in one or more indication cohorts before the end of CY2026.
Looking Forward
Entropy believes the basket study could generate several meaningful clinical milestones over the coming months. Key anticipated milestones over the next 12 months include recruitment and dosing progress, cohort-level outcome data, additional Binge Eating Disorder (搜索) data, biomarker analyses, identification of lead indications, validation of the broader transdiagnostic platform strategy, and potential partnering and development opportunities.