The first patient in a clinical trial by Tryptamine Therapeutics Ltd (ASX:TYP) for the treatment of Irritable Bowel Syndrome (IBS) has been treated at Massachusetts General Hospital (MGH) in the US.
The clinical-stage biotech is running a Phase 2a trial weighing the effectiveness of oral psilocybin – TRP-8802 – combined with psychotherapy in the treatment of IBS, a condition that affects an estimated two in 10 people.
First use of psilocybin
The trial is a collaboration with MGH, a leading member of the Mass General Brigham health system and Harvard's oldest hospital. It marks the first time MGH has administered psilocybin in a clinical study.
Up to 10 patients will be dosed, with results expected in the first quarter of 2025.
The primary efficacy endpoints include a reduction in chronic abdominal pain and visceral tenderness.
MGH is renowned for its psychiatric services, having been ranked number one in the US, and hosts the largest hospital-based research enterprise in the country, with a US$1.2 billion annual budget in 2021.
The research institute boasts more than 9,500 researchers across 30 institutes, centres and departments.
Results from this trial will inform further studies using TRP-8803 – IV-infused psilocin – Tryp’s lead asset.
TRP-8803 is expected to offer significant advantages over oral psilocybin, including improved efficacy and safety, faster onset of the psychedelic state, precise control over the experience and a reduced intervention duration.
Huge unmet need
IBS affects up to 20% of Australians and 15% of the US population, significantly impacting productivity and quality of life.
Tryp's ongoing and future clinical trials aim to address this large unmet medical need by exploring the gut-brain relationship and providing effective treatment options for IBS sufferers.
CEO Jason Carroll said: "We are excited to collaborate with Massachusetts General Hospital on this groundbreaking trial.
“The involvement of such prestigious institutions underscores the significant interest in using psychedelic compounds to treat unmet medical needs.
“This trial provides an opportunity to explore new treatment avenues for IBS, a condition with limited effective options."
About Tryptamine Therapeutics
Tryptamine Therapeutics is focused on developing novel formulations of psilocin for use in conjunction with psychotherapy to treat diseases with significant unmet medical needs.
The company's lead program, TRP-8803, offers potential benefits over oral psilocybin, including faster onset and more controlled psychedelic experiences.
TYP is also progressing additional clinical trials for conditions such as binge eating disorder and fibromyalgia.