Entropy Neurodynamics has successfully enrolled and dosed the first patient in its pioneering clinical trial of TRP-8803, an intravenous psilocin formulation targeting Binge Eating Disorder, while securing $6.1 million in new funding to accelerate development.
- First patient fully dosed in world-first TRP-8803 IV psilocin trial for Binge Eating Disorder
- Three patients enrolled in 12-patient clinical trial with second patient dosing imminent
- $6.1 million capital raising completed to fund clinical, manufacturing, and regulatory activities
- Received $847k R&D tax incentive for FY24 with $1.73 million expected for FY25
- Company rebrands to Entropy Neurodynamics to reflect broader neuropsychiatry focus
Clinical Breakthrough in Psychedelic Therapy
Entropy Neurodynamics Limited (ASX, ENP) has marked a significant milestone in its clinical-stage biotechnology journey by enrolling and fully dosing the first patient in its world-first clinical trial of TRP-8803, an intravenous formulation of psilocin, aimed at treating Binge Eating Disorder (BED). This pioneering trial, conducted in collaboration with Swinburne University, is designed to precisely control the onset, depth, and duration of the psychedelic experience, addressing limitations associated with oral psilocybin therapies.
The initial patient received two infusions spaced 14 days apart, demonstrating the treatment's safety and tolerability while achieving controlled psychedelic exposure. This success validates Entropy’s approach to precision-dosed neuropsychiatric therapies and sets the stage for further clinical advancements.
Building Momentum and Expanding the Trial
Following the first patient’s dosing, recruitment momentum continues with three patients now enrolled in the 12-patient trial. The second patient is expected to be dosed imminently, with top-line data from the first patient anticipated soon. The trial’s design includes two cohorts receiving mid-range and high-range doses respectively, with comprehensive follow-up to assess safety and clinical efficacy on binge-eating episodes and related psychological indicators.
Support from the Butterfly Foundation, Australia’s leading eating disorder charity, has been instrumental in raising awareness and aiding patient recruitment, reflecting growing recognition of BED as a serious mental health condition requiring innovative treatments.
Strengthening Financial Position to Accelerate Development
Entropy successfully completed a $6.1 million placement, bolstering its balance sheet to accelerate TRP-8803’s clinical development, manufacturing, and regulatory programs. The placement attracted strong support from existing shareholders, including key insiders and board members, underscoring confidence in the company’s strategic direction.
Additionally, the company received an $847,186 R&D tax incentive refund for FY24, with an expected further $1.73 million for FY25, providing non-dilutive funding to support ongoing clinical activities. As of 31 December 2025, Entropy held $8.38 million in cash and funding facilities, including a $650,000 drawdown from an R&D loan facility.
Strategic Rebranding Reflects Broader Neuropsychiatry Focus
In a move reflecting its evolution beyond psychedelic drug development, the company changed its name to Entropy Neurodynamics Limited and adopted the ASX code ENP. This rebranding aligns with its expanding focus on biomarker-driven neuropsychiatry and precision therapies, underpinned by the Entropic Brain Hypothesis and EEG-based biomarker development.
CEO Jason Carroll emphasised the transformational nature of the quarter, highlighting disciplined clinical execution and the company’s commitment to delivering early patient data and advancing TRP-8803 as a differentiated neuropsychiatric platform.
Looking Ahead
With plans for a large, multi-indication trial nearing completion and launch expected imminently, Entropy Neurodynamics is positioning itself at the forefront of psychedelic-assisted therapies. The coming months will be critical as the company releases initial clinical data and continues patient recruitment, potentially reshaping treatment paradigms for BED and other neuropsychiatric conditions.
Bottom Line?
As Entropy Neurodynamics prepares to unveil early clinical data, investors will watch closely to see if TRP-8803 can deliver on its promise to transform neuropsychiatric treatment.
Questions in the middle?
- How will the upcoming patient data influence regulatory and commercial prospects for TRP-8803?
- What is the anticipated timeline and scale for the planned multi-indication trial?
- How sustainable is the current recruitment momentum given the niche patient population?