First Patient Enrolled in TRP-8803 IV Psilocin Trial Targeting Binge Eating Disorder
Tryptamine Therapeutics has enrolled the first patient in its pioneering clinical trial testing TRP-8803, an IV-infused psilocin formulation, for Binge Eating Disorder. The study aims to evaluate safety and efficacy, potentially reshaping treatment options for millions.
- First patient enrolled in world-first IV psilocin trial for Binge Eating Disorder
- Trial to recruit 12 patients across two dosing cohorts with supportive therapy
- Primary focus on safety and tolerability, with secondary efficacy endpoints
- TRP-8803 offers rapid onset and controllable dosing advantages over oral psilocybin
- Study conducted at Swinburne University with dosing expected in coming weeks
A Milestone in Psychedelic Medicine
Tryptamine Therapeutics Limited (ASX – TYP) has announced the enrolment of the first patient in its world-first open-label clinical trial assessing TRP-8803, an intravenous (IV) infused psilocin formulation, for the treatment of Binge Eating Disorder (BED). Conducted at Swinburne University in Melbourne, this trial represents a significant step forward in addressing a condition that affects millions globally but remains inadequately treated.
The trial will involve 12 adult patients divided into two cohorts receiving either mid-range or high-range doses of TRP-8803, administered twice 14 days apart alongside supportive therapy. The primary endpoint is to evaluate the safety and tolerability of this novel treatment, with secondary objectives including its ability to induce a controlled psychedelic state and reduce binge-eating episodes, anxiety, depression, and weight-related measures.
Why TRP-8803 Could Change the Treatment Landscape
TRP-8803 distinguishes itself from traditional oral psilocybin treatments by delivering psilocin directly into the bloodstream via IV infusion. This method ensures rapid onset; approximately 15 minutes compared to 1 to 3 hours orally; and allows precise control over dosage and therapy duration. Unlike oral dosing, the infusion can be paused or adjusted in real time, enhancing patient safety and experience. Additionally, the shorter treatment sessions (1–2 hours) make TRP-8803 commercially viable for outpatient clinics, a notable improvement over the lengthy oral psilocybin sessions.
These advantages are underpinned by a robust intellectual property portfolio protecting the formulation, infusion methods, and disease-specific applications, positioning Tryptamine Therapeutics as a leader in next-generation neuropsychiatric therapeutics.
Building on Promising Clinical Foundations
The current trial follows encouraging Phase 2a data from a University of Florida study using oral psilocybin (TRP-8802), which demonstrated an average reduction in binge-eating episodes of over 80%, alongside sustained improvements in anxiety and depression. Tryptamine Therapeutics anticipates that TRP-8803’s delivery method will further enhance these outcomes.
Patient screening and clinician training have been meticulously completed, with baseline assessments now underway. These include comprehensive evaluations of binge eating behaviour, body mass index, neuropsychiatric status, and laboratory tests to ensure patient safety and robust data collection ahead of dosing, expected in the coming weeks.
Addressing a Critical Unmet Need
Binge Eating Disorder is one of the most common eating disorders worldwide, yet treatment options remain limited and often ineffective. By targeting this significant unmet medical need, TRP-8803 has the potential to establish a new therapeutic pathway not only for BED but also for other conditions such as fibromyalgia and irritable bowel syndrome, where the company is also conducting clinical trials.
CEO Jason Carroll highlighted the milestone, stating, "Enrolling the first patient in this ground-breaking study marks a pivotal step forward for the Company’s lead program and concludes a considerable amount of work undertaken alongside Swinburne University in its preparation."
Bottom Line?
As dosing begins, all eyes will be on TRP-8803’s ability to deliver safe, effective relief for BED and potentially transform psychedelic therapy.
Questions in the middle?
- Will TRP-8803 demonstrate superior efficacy and safety compared to oral psilocybin in BED patients?
- How quickly will additional patient enrolments progress, and what interim data might emerge?
- Could TRP-8803’s scalable IV delivery open broader commercial opportunities beyond BED?
