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Entropy Neurodynamics (ASX:ENP) has reported encouraging topline results from the first cohort of its Phase 2 clinical trial evaluating TRP-8803, with the precision-controlled psychedelic therapy delivering strong efficacy in patients with treatment-resistant binge eating disorder (BED).

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The Australian company said 50% of participants achieved complete clinical remission, recording no binge eating episodes during the four weeks following treatment, while every patient achieved clinically meaningful improvement, exceeding the trial’s primary and secondary efficacy endpoints.

Across the six-patient cohort, weekly binge eating episodes fell by 74%; broad improvements were also recorded in anxiety, depression, severity, and quality of life.

Anxiety scores declined by 58%, depression scores improved by 57%, binge eating severity fell by 58%, while life satisfaction increased by 63%.

Entropy said the results represent what it believes is the world’s first reported clinical efficacy data for precision-controlled intravenous psilocin, providing early validation of its proprietary psychedelic treatment platform.

Unlike traditional oral psychedelic therapies, TRP-8803 is designed to provide rapid onset, predictable treatment intensity and a controlled offset through intravenous infusion, improving dose precision and reducing variability between patients.

The Independent Data Safety Monitoring Board recommended the trial progress directly to Cohort 2 using the planned 60-minute infusion protocol without modification, supporting the treatment’s safety profile.

The company believes the results reduce key clinical and operational risks for the program while supporting future regulatory discussions, partnership opportunities and expansion into additional neuropsychiatric disorders.

Cohort 2 has already been fully enrolled, with baseline assessments due to begin this quarter and dosing expected to commence next month. Final results from the Phase 2 study are expected in fourth quarter CY26.

Entropy will also keep analysing biomarker and EEG data as it advances the development of TRP-8803 across a broader range of psychiatric indications.

ENP is up more than +6% today, at 34cps.

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The material provided in this article is for information only and should not be treated as investment advice. Viewers are encouraged to conduct their own research and consult with a certified financial advisor before making any investment decisions. For full disclaimer information, please click here.

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