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Highlights
Tryptamine Therapeutics gains approval to commence first-in-human trial for BED using TRP-8803
Study to assess safety and impact on BED and related psychiatric conditions
Patient recruitment underway with treatment scheduled to begin later in the year
Tryptamine Therapeutics Ltd (ASX:TYP), listed on the ASX 200, has obtained human ethics approval to begin a world-first clinical trial of TRP-8803, an intravenous psilocin formulation, targeting Binge Eating Disorder (BED). This study marks a major milestone in the development of novel psychedelic-assisted therapies for neuropsychiatric disorders.
The trial will be conducted in partnership with Swinburne University and is expected to begin patient dosing later in the year. Designed as an open-label investigation, the study aims to assess both the safety and impact of TRP-8803 when used alongside psychotherapy in adults diagnosed with BED.
Study Design Targets BED and Associated Psychiatric Comorbidities
The clinical trial will involve two groups of BED patients, with each participant receiving two TRP-8803 infusions. The infusions will follow preparatory and integration psychotherapy sessions. One group will receive a longer infusion period, while the second group will receive the same dosage over a shorter timeframe.
Throughout the study, researchers will monitor the safety and effect of the treatment over a twelve-week period after the second dose. In addition to primary measures, the research will explore outcomes related to eating behaviour, psychological wellbeing, and the potential influence on conditions such as anxiety, depression, post-traumatic stress disorder (PTSD), and compulsive behaviours.
Unmet Needs in BED Drive Clinical Interest
Binge Eating Disorder is a prevalent condition in the United States and Australia and is linked to significant emotional and physical impacts. Current treatment options often fail to address the full spectrum of symptoms and co-occurring mental health challenges. Tryptamine Therapeutics aims to offer a new pathway through psilocin-based therapy, supported by previous encouraging results with an oral formulation, TRP-8802.
The company’s transition from oral to intravenous dosing with TRP-8803 is intended to enhance precision, control treatment duration, and improve the therapeutic experience for patients.
TRP-8803 Progresses Across Broader Clinical Landscape
Beyond BED, TRP-8803 is also being investigated in other clinical settings, including fibromyalgia and irritable bowel syndrome (IBS). Each of these studies continues to build on earlier data showing strong efficacy signals with psilocybin-based compounds.
TRP-8803 is designed for enhanced delivery and clinical management, offering benefits such as rapid onset and reversibility. The upcoming trial will not only inform the future path of the BED program but may also contribute key data for other applications in neuropsychiatry.
Next Milestones in Trial Execution
Participant recruitment is now active, with enrolment processes and baseline assessments scheduled ahead of the first dosing. Dosing is anticipated to begin in the third quarter, with headline results expected to follow within the year.
This trial will form a critical part of Tryptamine Therapeutics’ wider development strategy, potentially shaping the company’s approach to future regulatory pathways and clinical expansion into other psychiatric and neurological conditions.
