Canadian company Tryp Therapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration for its planned phase 2a clinical trial studying the effects of psilocybin-assisted psychotherapy in the treatment of irritable bowel syndrome. The trial, which will be conducted in collaboration with Harvard Medical School/Massachusetts General Hospital, will evaluate patients with treatment-resistant IBS who experience chronic abdominal pain and other debilitating gastrointestinal symptoms. Tryp and Harvard/MGH will investigate whether psilocybin-assisted psychotherapy can alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety to improve IBS symptoms.
Why it matters: IBS is a debilitating condition suffered by millions globally, for which there is no cure. A successful trial could lead to the development of new treatments for those living with the condition.
What they are saying: “Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilizing the combined administration of psilocybin and psychotherapy. The clinical study will examine how psilocybin-assisted psychotherapy may alter brain networks involved in chronic abdominal pain and gastrointestinal-specific anxiety in patients with IBS to improve their symptoms,” said Jim Gilligan, CEO of Tryp Therapeutics.
The big picture: Tryp is focusing on unique areas for its clinical trials in which it believes it will have a first-mover advantage over its rivals. It has an ongoing phase 2a clinical trial for the treatment of binge eating disorder at the University of Florida and has planned a phase 2a trial for the treatment of fibromyalgia and irritable bowel syndrome at Mass General Hospital.
What to watch: Whether the trial of psilocybin-assisted psychotherapy for the treatment of IBS results in a cure for the condition, and whether the treatment is scalable to reach millions of people globally.
My take: The announcement marks a potentially significant advance in the treatment of IBS, an intolerable condition for sufferers and one that should be a focus for research. Given the impact of the condition, I welcome any development that can alleviate life-altering symptoms for those who suffer from it.
