The FDA completed a review of Tryp Therapeutics’ (CSE:TRYP; OTCQB:TRYPF) investigational new drug application, permitting the company to proceed with a Phase 2a clinical trial at Massachusetts General Hospital (MGH) investigating the effects of psilocybin-assisted psychotherapy in the treatment of patients aged 21 and older suffering from irritable bowel syndrome (IBS).
The primary efficacy endpoint of the study will be improvement in abdominal pain, which will be measured at four weeks post the final therapist-monitored psychedelic drug session, along with numerous other secondary endpoints including, changes in brain connectivity.
“We are eager for our collaborators at MGH to complete the work necessary to initiate enrolling patients in the study in the coming months,” Jim Gilligan, Ph.D., CEO Tryp, said in a statement.
“This novel approach holds great promise for this indication, especially considering the limited existing options for these IBS patients,” he added.
