Tryptamine opens patient recruitment for world-first Binge Eating Disorder trial

• Tryptamine Therapeutics starts patient recruitment for BED trial
• First psilocin dosing set for this quarter
• The company says this gives it a shot at unlocking a large market

Special Report: Tryptamine Therapeutics has kicked off patient recruitment for its world-first psilocin trial targeting Binge Eating Disorder (BED), with dosing set to start this quarter and a shot at unlocking a massive market.

It’s a major step for Tryptamine Therapeutics (ASX:TYP), a clinical-stage biotech, which has been steadily laying the groundwork for months.

Now, with the ink dry on its Clinical Trial Research Agreement with Swinburne University, Tryp is moving into execution mode.

The study, run in collaboration with Swinburne, will assess TRP-8803 – an IV-infused psilocin formulation – when administered with psychotherapy. The goal is to evaluate safety, feasibility and efficacy in adults diagnosed with BED.

Twelve patients will be recruited into two cohorts of six. Each will receive two doses of TRP-8803, spaced 14 days apart.

Cohort 1 will receive a mid-range dose and Cohort 2 will be given a high-range dose. All sessions will take place in a monitored setting, and include preparatory and integration psychotherapy.

“This highlights the sheer prevalence of BED in Australia, the need for new treatment options as well as Tryp’s opportunity to provide a potential treatment for this widespread condition,” said CEO Jason Carroll.

Behind the scenes

This recruitment milestone follows a formal agreement with Swinburne announced back in April. Since then, the company has been working behind the scenes to get the trial off the ground.

Tryp says it has now ticked off several major tasks – from governance approvals and patient protocols, to staff recruitment and finalising manufacturing schedules for TRP-8803.

The trial site is ready, the team is in place and Swinburne has already received multiple in-bound enquiries from potential participants. Patient screening is expected to begin imminently.

“Commencement of patient recruitment marks a major milestone in Tryp’s pursuit of this world-first clinical trial opportunity,” said Carroll.

“It follows a considerable level of work undertaken with Swinburne to finalise the clinical trial requirements, which has laid a very strong foundation for the initiative.”

Unlocking a large market

 First dosing is planned for this quarter and top-line results are expected in Q4, 2025.

BED is often associated with conditions like anxiety, depression, PTSD and compulsive behaviours – comorbidities that make treatment especially complex.

Success in the trial, Tryp said, had the potential to unlock a considerably large market for the company, as BED was the most common eating disorder in the US and second most prevalent in Australia.

Tryp said psilocin, based on previous neuropharmacology and clinical precedent, had shown potential as a treatment option when paired with psychotherapy.

“We expect patient screening to commence imminently allowing for first patient dosing this quarter,” Carroll added.

“I look forward to providing additional updates on enrolment and dosing in the coming weeks.”

Team behind the trial

The trial also comes off the back of a strategic boost to Tryp’s scientific bench. Just last week, the company brought on two high-profile appointments to support TRP-8803 and beyond.

Professor Marcel Mozafari, a nanotech veteran with 25 years’ experience and over 200 scientific publications, has joined as senior formulation scientist.

Professor David Castle, one of Australia’s most published mental health researchers and a known advocate for psychedelic therapies, is now part of the clinical team as consultant medical officer.

Their appointments were timed just ahead of this trial launch.

Now, with the team assembled, the trial design locked in, and interest already trickling through the inbox, things are moving.

The first patient has yet to be dosed, but  the runway is clear and momentum is building.

And if this trial opens the door to a new path for those living with BED, it might just be the start of something far bigger.

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

 This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.