Tryp Therapeutics and MGH will fund and conduct a Phase 2a clinical trial investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients suffering from Irritable Bowel Syndrome (IBS).
IBS is a common, chronic, and often debilitating condition with an estimated prevalence in the general population ranging from 4 to 5%. Research has demonstrated that a large percentage of IBS patients and gastroenterologists are dissatisfied by current treatments.
Tryp and MGH’s planned study will be evaluating the effect of psilocybin-assisted psychotherapy in patients over the age of 21 with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. Many of these patients also suffer from fibromyalgia, anxiety and fatigue.
The primary efficacy endpoint of the study will be improvement in abdominal pain. The study will also explore changes in brain connectivity and responses to pain at baseline, at four weeks, six months and twelve months, post-the psychedelic session, along with numerous other secondary endpoints.
Dr Erin Mauney, the paediatric gastroenterology fellow at Massachusetts General Hospital leading the proposed study, stated: “We are delighted to be partnering with Tryp Therapeutics, a recognised leader in the development of psilocybin-assisted therapies.
“There is tremendous potential for the treatment of debilitating IBS and other disorders of gut-brain interaction by utilising the combined administration of psilocybin and psychotherapy. Our clinical study will examine how psilocybin-assisted psychotherapy may alter important brain networks involved in chronic pain and gastrointestinal-specific anxiety in IBS to bolster the neural flexibility in these patients and thereby reduce visceral hypersensitivity.”
Jim Gilligan, PhD, Chief Executive Officer of Tryp Therapeutics, added: “MGH is an ideal partner for Tryp to expand on its strategy of utilising TRP-8802 (oral psilocybin) to explore the clinical potential of psilocybin-assisted psychotherapy in new indications.
“With positive results in this study, Tryp would look to continue clinical development in IBS with TRP-8803, our proprietary formulation of IV-infused psilocin, that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe.
“Our ultimate goal is providing even more favourable outcomes and relief to the millions of patients currently suffering from IBS and its associated disorders. With this agreement in place, we will be in a position to submit the relevant IND.”
