What It This Study About?
This is first -in-human (FIH) Phase 1b/2 study to demonstrate the safety and efficacy of EXE-346 live biotherapeutic to reduce high bowel frequency in subjects with an ileal-pouch anal anastomosis (IPAA).
The Phase 1b part will be an open-label, multicenter, single-arm study to assess the safety of EXE-346. Phase 2 part will be a randomized, double-blind, multicenter, placebo-controlled study to assess both the safety and efficacy of EXE-346
Patients who have undergone ileal-pouch anastomosis (IPAA) surgery have reported an increase in daily bowel movement frequency and urgency which interferes with daily activity. This study is intended to investigate the safety and efficacy of a new drug in development called EXE-346.
About EXE-346 Live Biotherapeutic
EXE-346 is a high-dose, “biologic cGMP grade” version of a commercially available food-grade probiotic formulation containing an 8-strain bacterial blend of live, lyophilized, gram-positive, lactic acid bacteria.
The food-grade formulation is used for the dietary management of dysbiosis associated with IBS, UC, antibiotic-associated diarrhea (AAD), pouchitis, and hepatic encephalopathy. It is similar to a probiotic to manage excessive stool frequency, urgency, loose stools, and nighttime stool frequency in patients who have undergone an IPAA.
The study sponsor, ExeGi Pharma, intends to seek FDA approval of this new product.