The Food and Drug Administration (FDA) has granted Orphan Drug designation to EXE-346 (ExeGi Pharma) for the prevention of disease relapse in pouchitis.

Pouchitis is an inflammation in the lining of a pouch that occurs after a surgical procedure, called an ileal pouch-anal anastomosis, to remove the colon. The surgery creates an intestinal “J-Pouch” with a portion of the lower intestine. The etiology of pouchitis is unknown, but studies suggest that it is caused by an abnormal immune response to the bacterial microflora of the pouch. 

EXE-346 is an orally administered, live biotherapeutic that contains a fixed-proportion of 8 strains of live probiotic bacteria. The product is intended to decrease the inflammation of the pouch and prevent active disease flare-ups.

“The J-Pouch surgery is a great option for many people that have long suffered from ulcerative colitis and other rare conditions, but pouchitis can occur in a significant portion of these patients,” commented Dr Paolo Gionchetti of the University of Bologna in Italy. “I am pleased to see that the US FDA has granted this product Orphan status because these patients need new treatment options to help maintain a normal quality of life.” 

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The FDA’s Orphan Drug designation is granted to medicines intended to treat or prevent rare diseases or disorders that affect fewer than 200,000 individuals. 

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ExeGi Pharma announces FDA Orphan Drug designation for EXE-346 live biotherapeutic. [press release]. Rockville, MD: ExeGi Pharma LLC; November 13, 2020.