FDA clears IND application to treat excessive stool frequency in patients with J-pouches
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The FDA cleared the investigational new drug application for ExeGi Pharma LLC’s, EXE-346, a live biotherapeutic biologic drug intended for patients with ileal pouch-anal anastomosis who experience excessive stool frequency.
Patients who undergo ileal pouch-anal anastomosis – or J-pouch procedure – may later experience excessive stool frequency of six or more times daily, with nighttime stool frequency also reported as a common problem. With no currently approved therapies to manage this condition, the FDA clearance will allow ExeGi Pharma to start enrollment for a clinical trial to evaluate EXE-346 for patients with J-pouches.
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“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,” Hans Herfarth, MD, PhD, from the University of North Carolina Inflammatory Bowel Disease Center, said in the release. “We believe that the live biotherapeutic approach has the potential to revolutionize the way we manage this condition.”
The company noted that it intends to initiate the study at various centers around the U.S. beginning in the summer of 2023.
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