ExeGi Pharma, a leader in the development of live biotherapeutic drugs and probiotics, announced that the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346. This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or "J-Pouch") who experience excessive stool frequency.

“Excessive stool frequency is a significant challenge for many patients with a J-Pouch, and we are pleased to have the opportunity to investigate the potential benefits of EXE-346," commented Dr. Hans Herfarth, MD, Ph.D., of the University of North Carolina Inflammatory Bowel Disease Center. And "We believe that the live biotherapeutic approach has the potential to revolutionize the way we manage this condition."

EXE-346 is a unique live biotherapeutic biologic drug that contains strains of live probiotic bacteria in extremely high potency. There are currently no approved treatments for managing excessive stool frequency in patients with a J-Pouch. ExeGi anticipates initiating the study at multiple centers throughout the U.S. in the summer of 2023.