Tryptamine Therapeutics Ltd has entered into an agreement with Swinburne University of Technology to initiate a world-first clinical trial evaluating psilocin for the treatment of Binge Eating Disorder (BED).
Psilocin, the active metabolite of psilocybin, is a naturally occurring psychedelic compound known to enhance neuroplasticity and influence mood and behavioural regulation.
TRP-8803, Tryp’s proprietary intravenous formulation of psilocin, will be administered alongside psychotherapy in the trial to assess its safety, feasibility and efficacy
Study highlights
The open-label trial will assess the safety and efficacy of TRP-8803 in adults with BED and is expected to begin patient recruitment this quarter.
At the outset, the study will enrol 12 participants across two six-person cohorts.
Subsequently, each participant will receive two doses of TRP-8803, administered 14 days apart, in a clinical setting with accompanying psychological support.
The first cohort will receive a mid-range dose, while the second cohort will be administered a high-range dose.
The study will be led by Professor Susan Rossell, a cognitive neuropsychologist and Professorial Research Fellow at Swinburne’s Centre for Mental Health.
"Important step"
Commenting on the developments, Tryptamine Therapeutics CEO Jason Carroll said: “Our CTRA to commence this world-first clinical patient trial for our lead drug treatment TRP-8803 marks an important step forward in Tryp’s clinical development pathway and builds off the strong results from our Phase 1b trials in H2 CY2024, where TRP-8803 met key safety parameters for a diverse subject population."
“We have worked diligently to prepare the trial framework alongside our partners at Swinburne in accordance with the highest standards of safety and quality control and are excited to commence patient recruitment and dosing as soon as possible."
Promising results
The trial builds on promising results from a Phase 2a study by the University of Florida, in which an earlier oral formulation of psilocybin (TRP-8802) reduced BED episodes by more than 80%.
TRP-8803 was selected for further clinical development given the urgent need for treatment options — there are currently no approved therapies specifically developed for BED, the most common eating disorder in the United States.
Furthermore, Tryp also plans to advance TRP-8803 into additional clinical trials targeting a broader range of neuropsychiatric conditions.
“The proprietary dataset generated from this trial, as well as other clinical trials which are in the final stages of planning are expected to provide unique insights to further inform and optimise our clinical development and regulatory pathways for a truly innovative treatment," Carroll said. "We look forward to providing additional updates on patient recruitment and trial commencement shortly.”
About BED
Binge Eating Disorder frequently co-occurs with conditions such as depression, anxiety, post-traumatic stress disorder (PTSD), and sleep disturbances, areas where psilocin-based therapies have previously demonstrated potential.
Research also indicates that between 25% and 50% of obese patients seeking weight-loss support may suffer from BED.