Tryp Therapeutics has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the initiation of its planned Phase IIa clinical trial of TRP-8802 oral psilocybin combined with psychotherapy to treat irritable bowel syndrome (IBS).

The open-label study will be conducted in partnership with Harvard Medical School/Massachusetts General Hospital.

It will investigate the effects of psilocybin-assisted psychotherapy in patients aged 21 and above with treatment-resistant IBS.

Patients with IBS have chronic abdominal pain along with unbearable gastrointestinal symptoms. They also suffer from anxiety, fatigue, and fibromyalgia.

Improvement in abdominal pain of the patients will be the primary efficacy endpoint of the study.

Changes in brain connectivity will be explored in the study, along with other secondary endpoints.

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Post the psychedelic drug sessions, responses to pain at baseline at four weeks, six months and 12 months will also be examined during the study.

Tryp Therapeutics CEO Jim Gilligan said: “Tryp and our collaborators at Harvard/MGH believe there is tremendous potential for the treatment of debilitating IBS symptoms by utilising 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.

“Submission of IND 163994 is an important step in advancing our programme.”

TRP-8802 is also being evaluated in an ongoing Phase IIa trial for the treatment of Binge Eating Disorder and an upcoming Phase IIa trial for the treatment of fibromyalgia.