Tryp’s TRP-8803 Trial Marks Critical Step Amidst Clinical and Corporate Changes
Tryptamine Therapeutics has secured a landmark agreement with Swinburne University to initiate the first clinical trial of its IV-infused psilocin formulation TRP-8803 for Binge Eating Disorder, aiming to build on promising Phase 2a data.
- Clinical Trial Research Agreement executed with Swinburne University for TRP-8803 in BED
- Trial to recruit 12 patients in two cohorts with dosing two weeks apart
- Positive Phase 2a data from University of Florida showed >80% reduction in binge eating scores
- Company holds $4.58 million cash with expected $0.9–1.0 million R&D tax refund
- Operational updates include auditor change to BDO and new Company Secretary appointment
A World-First Clinical Trial for Binge Eating Disorder
Melbourne-based clinical-stage biopharmaceutical company Tryptamine Therapeutics Limited (ASX: TYP) has taken a significant step forward in its clinical development program by formalising a Clinical Trial Research Agreement with Swinburne University. This agreement sets the stage for a pioneering open-label clinical trial investigating TRP-8803, an innovative intravenous psilocin formulation, as a treatment for Binge Eating Disorder (BED).
Binge Eating Disorder is the most common eating disorder in the United States and the second most prevalent in Australia, often accompanied by psychiatric comorbidities such as depression, anxiety, and PTSD. The trial will enrol 12 adult patients divided into two cohorts, each receiving two doses of TRP-8803 spaced two weeks apart, alongside psychotherapy. The primary focus is to evaluate safety and feasibility, with secondary objectives assessing clinical efficacy and the psychedelic experience induced by TRP-8803.
Building on Strong Phase 2a Data
This clinical initiative follows encouraging interim results from a Phase 2a study conducted at the University of Florida using oral TRP-8802, a synthetic psilocybin compound. That study demonstrated a mean reduction exceeding 80% in patient binge eating scores, underscoring the potential of psilocin-based therapies in this indication. Tryp’s TRP-8803 formulation offers advantages over oral dosing, including faster onset, precise control over the psychedelic state, and the ability to rapidly halt treatment if adverse events occur.
The trial is slated to commence in the June quarter of 2025, with initial high-level results expected by the fourth quarter. The data generated will not only inform the utility of TRP-8803 in BED but also its impact on associated psychiatric comorbidities, potentially broadening the therapeutic scope of the drug.
Financial and Corporate Developments
Financially, Tryp reported a cash balance of $4.58 million as of March 31, 2025, bolstered by the settlement of a placement tranche and an anticipated Australian Tax Office R&D tax refund of approximately $0.9 to $1.0 million. Operating outflows have decreased compared to the prior quarter, reflecting the completion of Phase 1b studies.
Corporate governance updates include the appointment of BDO Audit Pty Ltd as the new auditor, replacing William Buck Audit, and the promotion of Chief Financial Officer Hamish George to Company Secretary. These changes align with Tryp’s expanding clinical and corporate activities as it prepares for the upcoming trial.
Strategic Positioning and Future Outlook
CEO Jason Carroll highlighted the significance of the Swinburne trial as a foundational milestone, emphasizing the company’s commitment to advancing TRP-8803’s clinical development. The trial’s design, incorporating psychotherapy alongside dosing, reflects a modern approach to psychedelic-assisted treatments, aiming to maximize patient outcomes and safety.
Beyond BED, Tryp is actively exploring TRP-8803’s potential across other neuropsychiatric conditions lacking effective treatments. The company’s participation in the Biotech Showcase 2025 in San Francisco further signals its intent to attract strategic partnerships and broaden its clinical pipeline.
Bottom Line?
As Tryp embarks on this groundbreaking trial, the coming months will be critical in validating TRP-8803’s promise and shaping the future of psychedelic therapies for eating disorders.
Questions in the middle?
- How will the small trial size of 12 patients impact the robustness and regulatory acceptance of the data?
- What are the timelines and criteria for progressing TRP-8803 into larger, controlled studies if initial results are positive?
- How might Tryp leverage partnerships or funding to accelerate development across other neuropsychiatric indications?
