Second patient joins world-first Tryptamine psilocin trial targeting binge eating disorder

• Second patient enrolled in Tryptamine’s world-first intravenous psilocin trial for binge eating disorder
• Additional participants currently being screened, with further enrolments anticipated in the near term
• Trial secures recruitment support from the Butterfly Foundation, Australia’s leading charity supporting people affected by eating disorders

Special Report: Tryptamine Therapeutics has enrolled a second patient in its world-first clinical trial investigating its IV-infused psilocin therapy TRP-8803 for binge eating disorder (BED), as a leading national advocacy organisation steps in to support recruitment.

The trial of Tryptamine Therapeutics’ (ASX:TYP) TRP-8803 in BED is being conducted in collaboration with Swinburne University.

It will recruit 12 patients split across two six-person cohorts with each participant receiving two TRP-8803 infusions spaced 14 days apart, combined with supportive therapy.

The first cohort will receive a mid-range dose and the second a higher-range dose.

Tryptamine said the second enrolment followed extensive screening and clinical interviews to ensure safety and suitability, with baseline assessments now underway.

Assessments include binge-eating behaviour monitoring, body mass index (BMI) tracking, vital signs and comprehensive psychological and safety evaluations.

Additional candidates are currently being screened with more enrolments expected shortly.

First patient dosing for the landmark study is scheduled for December 1, marking the initial clinical administration of TRP-8803 in a BED population with top-line results from the trial expected in Q1 CY26.

Butterfly Foundation backing trial

The trial has also secured recruitment support from the Butterfly Foundation, Australia’s leading charity dedicated to supporting people affected by eating disorders and body image concerns, along with their families and carers.

The foundation provides Australia’s only National Helpline for eating disorders, counselling, recovery programs and advocacy initiatives to improve access to care and reduce stigma.

It also plays a key role in education, early intervention, and improving treatment pathways, working alongside clinicians, researchers and policymakers to drive improved treatment pathways and health outcomes.

The foundation has provided community-based support to assist with awareness, patient engagement and broader education surrounding BED since its inclusion in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) in 2013.

In recent weeks, it also assisted with patient recruitment initiatives for the trial of TRP-8803 in BED.

The foundation’s support reflects growing recognition of BED as a serious and widespread mental health condition requiring specialised clinical attention and new therapeutic approaches.

“Binge eating disorder is one of the most common eating disorders, impacting more than 230,000 people in Australia in any given year,” the foundation’s CEO Dr Jim Hungerford said.

“Despite this, binge eating disorder is often shrouded in stigma and shame, and many people are unable to access the treatment and support they need.

“Further research into binge eating disorder and additional treatment options is critical to breaking down stigma and encouraging help-seeking, and we look forward to seeing the results of this world-first clinical trial.”

Tryptamine CEO Jason Carroll said support of the Butterfly Foundation will be instrumental in raising awareness and connecting with patients who may benefit from participating in this study.

“Their support underscores the importance of developing safe, evidence-based therapeutic pathways for people living with BED,” he said.

Carroll said advancing additional recruitment initiatives and moving towards first patient dosing marked a pivotal milestone for the company and for the field of psychedelic-assisted treatment.

“Importantly, the company now has a scheduled date for the first time TRP-8803 will be evaluated in a patient with binge eating disorder,” he said.

“We look forward to commencing first patient dosing on 1 December, alongside additional patient enrolment, and reporting top-line results in Q1 2026.”

This article was developed in collaboration with Tryptamine Therapeutics, a Stockhead advertiser at the time of publishing.

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