Melbourne-headquartered Tryptamine Therapeutics (ASX: TYP) has dosed the first patient in its Phase 2a clinical trial investigating the treatment of Irritable Bowel Syndrome (IBS).
This marks the first time that Massachusetts General Hospital (MGH) has administered psilocybin in a clinical setting.
The trial seeks to evaluate TRP-8802 (oral psilocybin) in conjunction with psychotherapy in patients with IBS, a common disorder which affects an individual’s stomach and intestines. The primary efficacy endpoint in this study is reduction in chronic abdominal pain and visceral tenderness.
The open label exploratory trial will seek to dose up to ten participants that suffer from IBS with TRP-8802 administered in conjunction with psychotherapy to explore the effectiveness of the combination in treating IBS patients. Additional participants will be dosed over the coming months, allowing for results to materialise during Q1 2025.
MGH is home to the largest hospital-based research enterprise in the US, with an annual budget of US$1.2 billion in 2021. The Mass General Research Institute comprises more than 9,500 researchers working across over 30 institutes, centres and departments. Mass General has been a leader in bridging innovative science with highly advanced clinical care for more than 200 years.
Results will be used by the company to inform additional clinical studies into IBS utilising TRP-8803 (IV-infused psilocin), which has a number of potential advantages over oral dosing. These include improved efficacy and safety, along with enhancing both the patient and therapist experience.
Potential advantages of Tryp’s IV-infused psilocin solution also include a significant reduction in the time to onset of the psychedelic state, more precise control of the depth and duration of the psychedelic experience and a reduction in the overall duration of the intervention to a commercially feasible timeframe.
IBS is a large addressable market opportunity for Tryp. It is estimated to affect 20% of Australians, up to 15% of the total US population, and can lead to workplace absenteeism and a significant drop in productivity. The company is confident that this clinical trial and future work may provide a benefit to IBS sufferers in exploring the root cause of the condition, as well as treating its debilitating symptoms.
“We are very excited to have commenced this trial in collaboration with Massachusetts General Hospital and to be involved in the group’s maiden dosing using a psychedelic compound. This development and the high calibre organisations involved reflect the considerable interest in the use of psychedelic compounds to treat unmet medical needs,” CEO, Jason Carroll, said.
“IBS provides a very interesting test case for TRP-8802 and TRP-8803, primarily due to the nature of current treatments available. While the condition has been shown to be a neuro-gastrointestinal disorder, little is known about the root cause. This provides Tryp with the opportunity to delve deeper into the gut and brain relationship. We look forward to continuing our work alongside Mass General over the coming weeks to complete patient dosing.”
