Entropy Neurodynamics Posts 50% Remission in BED Trial and Expands IBS Patent Portfolio

Clinical Breakthrough in Binge Eating Disorder Trial

Entropy Neurodynamics Limited (ASX:ENP) has delivered compelling topline results from the first cohort of its Phase 2 trial evaluating TRP-8803, an intravenous (IV) psilocin formulation, in treatment-resistant Binge Eating Disorder (BED). The study reported a 50% clinical remission rate, defined as zero binge episodes over four weeks post-treatment, alongside a 100% clinically meaningful response rate, surpassing the trial’s primary efficacy endpoint.

The results mark the world’s first clinical validation of a precision-controlled IV psilocin platform, demonstrating rapid onset, predictable treatment intensity, and controlled offset. Secondary outcomes also impressed, with a 74% reduction in weekly binge episodes, 58% reductions in both binge severity and anxiety, a 57% drop in depression scores, and a 63% improvement in life satisfaction.

Safety Board Endorses Progression to Second Cohort

The Independent Data Safety Monitoring Board (DSMB) reviewed the cohort 1 data and recommended progression to cohort 2 without any protocol changes, endorsing the favourable safety and tolerability profile observed. Recruitment for cohort 2 is complete, with dosing under the original 60-minute infusion regimen commencing imminently and topline results expected in the fourth quarter of calendar year 2026.

Strong Phase 2a Results in Irritable Bowel Syndrome Validate Mechanism

Entropy also revealed landmark Phase 2a data from its oral psilocybin TRP-8802 trial in treatment-resistant Irritable Bowel Syndrome (IBS). Conducted by researchers at Massachusetts General Hospital and Columbia University, the study achieved a 75% clinically meaningful response rate, significantly outperforming the 17–44% rates typical of approved IBS therapies.

Response rates were especially notable across subtypes, with 100% of IBS-Constipation (IBS-C) patients and 80% of IBS-Mixed (IBS-M) patients responding. The trial also linked symptom improvements to enhanced psychological flexibility, reinforcing the gut-brain axis as the therapeutic target. This mechanistic validation supports Entropy’s development strategy and bolsters the commercial potential of the TRP-8803 IV platform as a faster, more controllable alternative to oral psychedelics.

Intellectual Property Expansion with New US Patent Filing

In a strategic move to protect its innovations, Entropy filed a new US provisional patent application covering TRP-8803’s use in IBS treatment. This filing builds on clinical insights from the Phase 2a TRP-8802 study and complements the company’s existing international patent portfolio, including a Patent Cooperation Treaty application and an Australian patent protecting its precision-controlled psilocin administration method through 2042.

The expanded IP estate strengthens Entropy’s position for US regulatory engagement and partnering discussions, enhancing the exclusivity of its precision-controlled IV psilocin platform across multiple gut-brain and neuropsychiatric indications.

Financial Position and Operational Investment

As of 30 June 2026, Entropy Neurodynamics held $8.2 million in cash and available funding facilities. The company’s cash flow reflects ongoing investment in clinical trials, manufacturing, and corporate activities, including the purchase of advanced EEG equipment to support upcoming dosing studies and the development of therapist training protocols.

Notably, clinical program extensions and additional cohorts have increased trial costs beyond initial prospectus estimates, reflecting the company’s commitment to robust data generation. The R&D loan facility with Rockford Equity Pty Ltd remains undrawn, providing additional financial flexibility.

Payments to related parties during the quarter totalled $121,000, covering executive and non-executive director remuneration.