Clinical-stage biotechnology company Tryptamine Therapeutics Ltd (ASX:TYP, OTC:TYPTF), has launched patient recruitment for a first-of-its-kind clinical trial assessing TRP-8803, an IV-infused psilocin, as a potential treatment for Binge Eating Disorder (BED).
This trial, in collaboration with Swinburne University, aims to explore the safety, feasibility, and efficacy of TRP-8803 when administered alongside psychotherapy for adults living with BED.
Recruitment and study details
The open-label trial will recruit 12 participants, divided into two cohorts of six patients each.
Participants will be administered two doses of TRP-8803, spaced 14 days apart, in a controlled setting, following preparatory psychotherapy. The first cohort will receive a mid-range dose, while the second will receive a higher-range dose.
Initial patient screenings are expected to begin soon, with first dosing planned for this quarter and top-line results anticipated in Q4 CY2025.
The trial is designed to evaluate the potential of TRP-8803, a proprietary formulation of psilocin, to address the challenges of BED — the most common eating disorder in the US and the second most prevalent in Australia. The disorder is often linked with obesity and severe psychiatric comorbidities such as depression, anxiety, PTSD and compulsive behaviours.
A key step for Tryptamine
This recruitment phase marks a significant milestone for Tryptamine Therapeutics, following the completion of governance approvals, submission of necessary permits and finalisation of clinical protocols. The company has worked closely with Swinburne University to establish a strong foundation for the trial, with patient recruitment now under way.
“Commencement of patient recruitment marks a major milestone in Tryp’s pursuit of this world-first clinical trial opportunity,” Tryptamine Therapeutics CEO Jason Carroll said.
“To date, Swinburne has received considerable in-bound interest from a number of potential participants,” he said. “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.”
Patient screening is set to commence imminently, with the first dosing expected this quarter.
Psilocin’s potential for BED treatment
Psilocin, the active metabolite of psilocybin, has shown promise as a therapeutic agent in treating a variety of mental health conditions, and its application in BED could provide an important new treatment option in this area.
Previous clinical studies have demonstrated that psilocin has the potential to address many of the shortcomings of oral psilocybin, including a faster onset of action and better control over the psychedelic experience.
Tryptamine’s lead program, TRP-8803, is designed to offer a more controlled and efficient treatment experience, which may result in improved patient outcomes. The company has already completed a Phase 2a trial for BED in the United States, showing an impressive 80% reduction in binge eating episodes.
With this new trial, Tryptamine aims to build on these findings and further solidify psilocin’s potential as a viable treatment option.
Outlook and future studies
Success in this trial could pave the way for further clinical studies and bring Tryptamine Therapeutics closer to revolutionising the treatment of BED. The company is also exploring additional indications for TRP-8803, including fibromyalgia and irritable bowel syndrome, further expanding its pipeline.
As patient recruitment continues, Tryptamine Therapeutics remains focused on advancing this pioneering trial and delivering critical insights into the treatment of BED, a condition affecting millions of people worldwide.