What It This Study About?
A 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)
Patients who have undergone ileal-pouch anastomosis (IPAA) surgery have reported an 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 an investigational new drug comprised of live bacteria, similar to a probiotic. The study sponsor, ExeGi Pharma, intends to seek FDA approval of this new product