Entropy Neurodynamics Reports 50% Remission in BED Trial and Expands Clinical Program
Entropy Neurodynamics (ASX:ENP) reported a 30% rise in income and a narrower loss for FY26, driven by clinical progress in its IV-infused psilocin therapy TRP-8803, including promising Phase 2 results in Binge Eating Disorder and a new multi-indication basket study.
- 30% income increase to $2.06 million
- Loss after tax narrowed 8.7% to $4.87 million
- Phase 2 BED trial shows 50% complete remission in Cohort 1
- 72-patient multi-indication basket study approved
- New patents granted in Australia and South Africa
Clinical Breakthrough in Binge Eating Disorder Trial
Entropy Neurodynamics Limited (ASX:ENP) has taken a significant step forward in its clinical development with TRP-8803, its proprietary intravenous psilocin formulation. The company reported that in Cohort 1 of its Phase 2 trial for treatment-resistant Binge Eating Disorder (BED), all six patients achieved a clinically meaningful response, with half reaching complete clinical remission within four weeks post-treatment. Weekly binge episodes dropped by 74%, alongside substantial improvements in anxiety, depression, and life satisfaction scores.
This early efficacy data, while based on a small patient group, validates the company’s strategy to overcome the limitations of oral psilocybin through precision-controlled IV delivery, offering rapid onset (~20 minutes), predictable treatment intensity, and controlled offset. The independent Data and Safety Monitoring Board endorsed progression to the second cohort without changes to the 60-minute infusion protocol, underscoring the safety and tolerability profile of TRP-8803.
Expanding Clinical Footprint with Multi-Indication Basket Study
Building on the BED program, Entropy secured Human Research Ethics Committee approval for a 72-patient Phase 1b/2a multi-indication basket study. This trial will assess TRP-8803 across eight disorders including anorexia nervosa, fibromyalgia, generalised anxiety disorder, and treatment-resistant major depressive disorder. The basket study offers a capital-efficient approach to generate safety and preliminary efficacy data across multiple high unmet need conditions, providing a strategic framework to prioritise future development.
Alongside its lead program, Entropy continues to leverage TRP-8802, its oral psilocybin formulation, as a clinical pathfinder. Phase 2a data in BED and Irritable Bowel Syndrome (IBS) have shown durable and encouraging responses, with 75% of treatment-resistant IBS patients achieving clinically meaningful improvements. This evidence informs the selection of indications for TRP-8803's development.
Strengthening Intellectual Property and Biomarker Platforms
During FY26 and post-year end, Entropy expanded its intellectual property portfolio with new patents granted in Australia for proprietary crystalline forms of psilocin and in South Africa covering psilocybin-based fibromyalgia treatments. These patents extend protection to 2043 and encompass pharmaceutical compositions, manufacturing methods, and therapeutic applications.
Complementing the drug delivery platform, Entropy entered an exclusive agreement with leading researchers to develop an EEG-based brain entropy biomarker platform. This initiative aims to integrate quantitative neurophysiological measures with TRP-8803’s controlled dosing, potentially enabling real-time treatment optimisation and personalised therapy.
Financial Position and Corporate Developments
Financially, Entropy reported a 30% increase in income to $2.06 million for FY26, largely driven by R&D tax incentives, while reducing its loss after tax by 8.7% to $4.87 million. The company bolstered its cash reserves to $5.58 million, supported by a $6.1 million placement and a $2.6 million R&D loan facility secured against future tax incentives.
Entropy also rebranded from Tryptamine Therapeutics to better reflect its broader neuropsychiatry platform approach, with the ASX ticker changing to ENP. The board comprises experienced executives including Non-Executive Chairman Herwig Janssen and CEO Jason Carroll, who bring deep pharmaceutical and business development expertise.
What’s Next for Entropy?
Looking ahead, Entropy’s immediate focus is on completing the Phase 2 BED trial’s second cohort and delivering full study results by late 2026. Concurrently, the company plans to initiate dosing in the multi-indication basket study, expanding the clinical data set for TRP-8803 across diverse neuropsychiatric and somatic disorders.
Additionally, Entropy has entered a pre-clinical trial agreement with the University of California, San Francisco, to explore TRP-8803 versus escitalopram in Major Depressive Disorder, signalling plans to broaden its clinical and geographic footprint. The company’s evolving IP portfolio, biomarker development, and capital position will be critical as it navigates regulatory pathways and potential partnering discussions.
Bottom Line?
Entropy’s early clinical signals in BED and multi-indication expansion position TRP-8803 as a promising precision psychedelic therapy, but the path to regulatory approval and commercialisation remains contingent on larger datasets and continued funding.
Questions in the middle?
- Will the encouraging Phase 2 BED results replicate in larger, more diverse patient populations?
- How effectively can Entropy’s EEG biomarker platform enhance personalised dosing and treatment outcomes?
- What regulatory and scheduling hurdles will TRP-8803 face in key markets like the US?