ExeGi Pharma LLC, which develops live biotherapeutic drugs and probiotics, says the FDA has cleared its Investigational New Drug (IND) application for its biologic drug candidate, EXE-346.
The 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,” said Hans Herfarth, of the University of North Carolina Inflammatory Bowel Disease Center.
“We believe that the live biotherapeutic approach has the potential to revolutionize the way we manage this condition.”
An ileal pouch-anal anastomosis is a surgical procedure typically performed because of unresolved inflammatory bowel disease (IBD). The surgery creates an intestinal J-Pouch with a portion of the lower intestine, allowing patients to avoid an ostomy bag and pass stools normally.
However, many patients with a J-Pouch experience excessive daily stool frequency of six or more times per day. Nighttime stool frequency is also a common complication. The clinical study will seek to evaluate the safety of ExeGi Pharma’s EXE-346 and its initial efficacy in the potential reduction of stool frequency.
EXE-346 is a 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 Pharma anticipates initiating the study at multiple centers throughout the U.S. in the summer of 2023.