Tryp receives green light for world-first psilocin trial targeting binge eating disorder

Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF) has secured human ethics approval to start a global-first clinical trial of its intravenous psilocin-based formulation TRP-8803 in adults with Binge Eating Disorder (BED). The open-label study, conducted in collaboration with Swinburne University, will evaluate the safety and efficacy of TRP-8803 when paired with psychotherapy.

Twelve participants will be enrolled, with dosing expected to begin in the third quarter of calendar year 2025 (Q3 CY25) and top-line results anticipated by year-end. BED is the most common eating disorder in the United States and the second most common in Australia, representing a substantial unmet medical need and commercial opportunity.

The trial will also assess the potential of TRP-8803 to impact common BED-related conditions, including depression, anxiety, post-traumatic stress disorder (PTSD) and compulsive behaviours.

“While Binge Eating Disorder is not widely publicised, it is incredibly widespread with many sufferers also experiencing a range of other neuropsychiatric conditions including anxiety, depression and PTSD amongst others. While the primary objective of this world first trial is to assess TRP-8803’s utility in Binge Eating Disorder, it will also provide valuable insight into how TRP-8803 may help with other neuropsychiatric disorders, in line with the company’s goal of delivering treatments to large, unmet conditions,” TYP CEO Jason Carroll said.

“With patient recruitment initiatives now underway, we look forward to first enrolment and the commencement of baseline data generation from participants, prior to first patient dosing.”

Study design and objectives

The trial will enrol 12 BED patients divided into two cohorts. Each patient will receive two TRP-8803 infusions, spaced 14 days apart. 

Cohort 1 will undergo a 140-minute infusion period, while Cohort 2 will receive the same dose over 60 minutes. Dosing will follow preparatory psychotherapy and integration sessions.

Primary objectives include evaluating safety and efficacy during the 12 weeks post-second dose. Secondary and exploratory measures will examine the psychedelic effect, binge episode frequency, and weight-related outcomes at four and 12 weeks. The trial will also provide data on TRP-8803’s effect on associated psychiatric comorbidities.

Rationale for targeting BED

BED affects about 7.3 million adults in the US and is associated with significant impairment and comorbid psychiatric conditions. Patients often experience a loss of control over eating, along with anxiety, depression, PTSD and social dysfunction. TRP-8803’s neuroplastic potential offers a novel approach to treating both BED and its associated conditions.

Tryp’s previous trial using oral psilocybin (TRP-8802) in collaboration with the University of Florida achieved more than 80% improvement in patient binge eating scores, providing a strong basis for this intravenous approach.

About TRP-8803 and development strategy

TRP-8803 is a proprietary intravenous psilocin formulation designed to improve onset time, control and treatment duration relative to oral psilocybin. Key advantages include precise dosing, reversibility in case of adverse events and commercial feasibility.

Tryp is also advancing TRP-8803 across other conditions, having completed Phase 2a trials in fibromyalgia and launched a study in irritable bowel syndrome (IBS). Each initiative builds on earlier oral psilocybin results, transitioning to the more targeted and controllable IV formulation.

Next steps and outlook

Patient recruitment is underway, with dosing of the first cohort scheduled for Q3 CY25. Four weeks of baseline data will be collected ahead of treatment commencement, and top-level data are expected in the fourth quarter. 

The results will guide broader development for TRP-8803 in BED and other psychiatric and neurological indications.