Patient screening is well underway for Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF)'s pioneering clinical trial investigating intravenous psilocin (TRP-8803) as a treatment for Binge Eating Disorder (BED), conducted in partnership with Swinburne University.
Swinburne has received a formal permit from the Victorian Department of Health to obtain and use controlled substances for research purposes. This regulatory milestone allows Tryp to start the supply of TRP-8803 to the university, with batch deliveries expected imminently and initial patient dosing scheduled for this quarter.
“The company continues to make very strong progress in relation to its trial with Swinburne and the receipt of this permit marks another milestone in our journey to deliver a potential treatment for BED, which is a far reaching and debilitating condition,” Tryp CEO Jason Carroll said.
“Our focus will now shift to supplying Swinburne with TRP-8803 for use in the trial, as well as assisting with patient enrolment. Given the level of enquiries to date and progress with initial patient screening, we remain on track for first enrolment this month and first dosing this quarter.”
Assessing safety
Tryp reported strong early interest in the study, with several prospective participants completing the initial application process. These individuals will proceed to in-person interviews next week, after which first enrolments will begin alongside baseline data collection.
The open-label study will enrol 12 adults with BED across two six-person cohorts. Each participant will receive two doses of TRP-8803, administered 14 days apart in a monitored clinical setting and supported by psychotherapy and integration. Cohort 1 will receive a mid-range dose, while cohort 2 will receive a higher dose.
The trial’s primary objective is to assess the safety of repeat TRP-8803 dosing, with follow-up extending to 12 weeks post initial administration. Secondary and exploratory endpoints include evaluating TRP-8803’s psychedelic activity, potential clinical effects on binge-eating frequency, and other weight-related health markers four weeks after the second dose.
Tryp also plans to analyse data for insights into TRP-8803’s potential utility in addressing comorbidities commonly associated with BED, which will inform its future clinical development strategy.