Tryptamine Therapeutics (ASX:TYP) has reached another critical milestone in its program to treat Binge Eating Disorder (BED), confirming the enrolment of a second participant in its clinical trial of TRP-8803, an intravenous formulation of psilocin.
The company also announced that the first patient will be dosed on 1 December, marking the first clinical administration of TRP-8803 in a BED population. Top-line results remain on track for the first quarter of 2026.
The Phase 2 trial, conducted in partnership with Swinburne University, will recruit twelve patients across two six-person cohorts. Participants will receive two doses of TRP-8803, spaced 14 days apart, alongside supportive therapy. The first cohort will be treated with a mid-range dose, while the second will receive a higher dose as part of the dose-escalation design.
Following the latest enrollment, the second participant has begun a four-week baseline period, which includes assessments of binge-eating behaviour, body mass index, vital signs, laboratory testing, neuropsychiatric evaluations, and safety measures. Several additional prospective participants are now progressing through the screening process, with further enrollments expected soon.
Patient recruitment is being supported by the Butterfly Foundation, Australia’s leading organisation for eating disorders and body-image concerns. The Foundation has provided community-based awareness and engagement support, reflecting the growing recognition of BED as a widespread mental health condition that requires new therapeutic approaches.
Butterfly Foundation CEO Dr Jim Hungerford welcomed the progress, noting that more than 230,000 Australians experience BED in any given year. “Further research into Binge Eating Disorder and additional treatment options is critical to breaking down stigma and encouraging help-seeking,” he said. “We look forward to seeing the results of this world-first clinical trial.”
“Advancing recruitment and moving towards first patient dosing marks a pivotal milestone for Tryp and for the field of psychedelic-assisted treatment,” said Tryptamine CEO Jason Carroll. “The support of Butterfly Foundation will also be instrumental in helping raise awareness and connect with patients who may benefit from participating in this study.”
TRP-8803 is Tryp’s proprietary intravenous formulation of psilocin, designed to overcome clinical and commercial limitations of oral psilocybin by providing faster onset, precise control over the depth and duration of the psychedelic experience, and a shorter overall treatment window. The company has previously demonstrated encouraging results in a Phase 2a BED study using its oral psilocybin formulation TRP-8802, achieving an average reduction in binge-eating episodes of more than 80 per cent.