In a groundbreaking development for psychiatric medicine, Tryptamine Therapeutics Ltd has partnered with Swinburne University of Technology to launch the world's first clinical trial evaluating intravenous psilocin for the treatment of Binge Eating Disorder (BED).
The landmark Clinical Trial Research Agreement (CTRA) will investigate TRP-8803, Tryptamine's proprietary intravenous formulation of psilocin—the active metabolite of psilocybin found in psychedelic mushrooms—administered alongside psychotherapy for patients suffering from BED.
Trial Design and Methodology
The open-label trial, expected to begin patient recruitment this quarter, will assess both safety and efficacy of TRP-8803 in adults diagnosed with BED. Initially, 12 participants will be enrolled across two six-person cohorts, with each participant receiving two doses of the investigational treatment administered 14 days apart in a controlled clinical setting.
The first cohort will receive a mid-range dose, while the second will be administered a high-range dose. Throughout the treatment process, participants will receive comprehensive psychological support as part of the psychedelic-assisted psychotherapy protocol.
Professor Susan Rossell, a cognitive neuropsychologist and Professorial Research Fellow at Swinburne's Centre for Mental Health, will lead the study. "Psychedelics have been shown to provide long-term meaningful benefits to people living with a range of different mental health conditions," Rossell stated. "Eating disorders—despite being amongst the most debilitating psychiatric illnesses—have remained largely unexplored in psychedelic research until now."
Scientific Rationale and Previous Findings
The trial builds upon promising results from a Phase 2a study conducted by the University of Florida, in which an earlier oral formulation of psilocybin (TRP-8802) demonstrated remarkable efficacy, reducing BED episodes by more than 80%.
Psilocin is known to enhance neuroplasticity and influence mood and behavioral regulation, mechanisms that may prove particularly beneficial for BED patients. The intravenous administration route represents a significant innovation over traditional oral delivery methods.
"Our innovation allows for more precise control over the onset and duration of the psychedelic experience and time in the potential therapeutic zone," explained Jason Carroll, CEO of Tryptamine Therapeutics. "As well, we have the ability to reverse treatment quickly if required. This opens up new possibilities for tailored and safer treatment to the individual needs of the patient."
Addressing a Significant Unmet Need
Binge Eating Disorder represents a substantial unmet medical need. It is the most common eating disorder in the United States and the second most common eating disorder globally. Despite its prevalence, there are currently no approved therapies specifically developed for BED.
The condition frequently co-occurs with other psychiatric disorders including depression, anxiety, post-traumatic stress disorder (PTSD), and sleep disturbances—areas where psilocin-based therapies have previously shown potential. Research also indicates that between 25% and 50% of obese patients seeking weight-loss support may suffer from BED.
Current treatment approaches typically involve a combination of psychologist-led therapy and prescribed medications to manage symptoms, but many patients continue to experience persistent symptoms despite these interventions.
Future Directions and Implications
Carroll emphasized the significance of this trial in Tryptamine's clinical development pathway: "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."
Beyond BED, Tryptamine Therapeutics plans to advance TRP-8803 into additional clinical trials targeting a broader range of neuropsychiatric conditions. The company anticipates that the proprietary dataset generated from this and other planned trials will provide unique insights to further optimize their clinical development and regulatory pathways.
Professor Rossell expressed hope that this research will catalyze global investment in treating BED: "Binge eating disorder is a debilitating disease that seriously impacts too many Australians lives. I'm thrilled to be part of an internationally-leading team committed to making real change with innovative solutions."
As the trial moves forward, both organizations have committed to maintaining the highest standards of safety and quality control, with updates on patient recruitment and trial commencement expected in the near future.
