Tryptamine Therapeutics Ltd (ASX:TYP; OTC: TYPTF), a clinical-stage biotech firm, has officially initiated patient recruitment for a groundbreaking clinical trial evaluating TRP‑8803—an intravenously administered formulation of psilocin—as a potential treatment for Binge Eating Disorder (BED).
This achievement marks the world’s first-ever clinical investigation of IV-delivered psilocin paired with psychotherapy for adults diagnosed with BED.
The trial, conducted in partnership with Swinburne University, is structured as an open-label, Phase 1 study with 12 participants divided into two cohorts of six. Each participant will receive two IV infusions of TRP‑8803, spaced 14 days apart, following preliminary psychotherapy sessions.
Cohort 1 will receive a mid-range dose; cohort 2 will receive a higher dose. Screening is expected to commence imminently, with first dosing scheduled for this quarter. Top-line data are anticipated in Q4 2025.
Why This Matters
Unmet medical need in BED: BED is the most common eating disorder in the US (affecting ~1.25% of adults annually) and the second most prevalent in Australia. It is closely associated with obesity and psychiatric comorbidities, such as depression, anxiety, PTSD, and compulsive behaviors.
Innovative drug delivery: Administering psilocin intravenously—rather than orally—offers several advantages: quicker onset, precise control over dosage and experience, adjustable infusion speed, and the ability to halt infusion mid-session if needed.
Promising prior data: A Phase 2a oral psilocybin trial at the University of Florida reported an impressive ~80% reduction in binge eating episodes.
TRP‑8803 aims to improve on those results through enhanced control and efficiency.
Trial Details at a Glance
| Parameter | Details |
|---|---|
| Design | Open-label, safety & feasibility |
| Participants | 12 adults with diagnosed BED |
| Treatment | Two IV doses of TRP‑8803, 14 days apart |
| Delivery method | Mid-range dose followed by a high-range dose |
| Psychotherapy accompaniment | Preparatory and integration therapy; no on-session talk |
| Endpoints | Safety, tolerability, psychedelic experience control, impact on binge episodes/comorbidities |
| Timeline | First dosing in Q3 2025; results expected Q4 2025 |
Expert & Patient Perspectives
Professor Susan Rossell from Swinburne, who leads the trial, emphasizes the transformative potential of psychedelic-assisted psychotherapy: “Psychedelics have been shown to provide long-term meaningful benefits… Eating disorders… have remained largely unexplored in psychedelic research until now”.
Echoing this, The Australian’s stock report notes strong interest from potential participants—a telling sign of BED’s prevalence and the community’s desire for new treatment options.
Safety & Ethical Oversight
In April, the trial received approval from Swinburne’s Human Research Ethics Committee, a crucial regulatory step that ensures adherence to ethical and safety standards.
Stylized delivery via IV drip enhances both precision and safety; infusion can be slowed or halted if any adverse reaction occurs—unlike with oral administration.
Context within Broader Psychedelic Research
The study adds to a growing body of evidence supporting psychedelic-assisted treatments in eating disorders. Recent academic reviews highlight their emerging efficacy in disorders characterized by rigid thinking, such as anorexia nervosa, though researchers emphasize the need for rigorous clinical trials.
A small feasiblity study in anorexia (2023) using psilocybin found the treatment to be safe, well-tolerated, and acceptable for patients
BioMed Central.
Tryptamine’s portfolio of TRP compounds—including TRP‑8802 and 8804—also tracks other conditions like fibromyalgia and IBS, indicating a broader exploration of psilocin’s therapeutic versatility.
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