Entropy Neurodynamics (ASX:ENP) has completed enrolment of the first cohort in its clinical trial of TRP 8803, an intravenously infused formulation of psilocin, marking a key operational milestone in the company’s push to develop new treatments for binge eating disorder.
The company confirmed that all six participants in Cohort 1 have now been recruited. Two patients have completed both dosing sessions, while others are progressing through baseline assessments and initial infusions in line with the study protocol.
The trial, conducted in partnership with Swinburne University, will enrol a total of 12 patients across two six-person cohorts, each receiving two doses administered 14 days apart alongside supportive therapy.
The first cohort is receiving a mid-range therapeutic dose. Based on safety and response data from this group, the second cohort will be treated with an optimised dosing regimen. Enrolment for Cohort 2 has already begun, with two patients recruited who will commence dosing after completion of the required follow-up period from the initial cohort.
The primary endpoint of the study is safety and tolerability over a 12-week observation period following the first dose. Secondary and exploratory measures include changes in binge-eating frequency, body mass index, weight-related outcomes, and broader psychological parameters.
Management has pointed to early clinical signals as a catalyst for recruitment momentum. The first treated patient demonstrated improvements four weeks after treatment, including reductions in binge eating severity, depression and anxiety, as well as gains in body image satisfaction and overall well-being.
According to chief executive Jason Carroll, these early results have reinforced confidence in the controlled intravenous delivery approach and validated the therapeutic rationale underpinning the study.
TRP 8803 is designed to address perceived limitations of oral psilocybin by offering faster onset, greater control over the intensity and duration of the psychedelic experience and a shorter overall treatment window.
Entropy believes this precision dosing model could improve scalability and commercial feasibility while maintaining clinical oversight.