ExeGi Pharma gets FDA orphan drug status for EXE-346 in pouchitis

ExeGi Pharma said that EXE-346 has been granted an orphan drug designation from the US Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis.

EXE-346 is a live biotherapeutic (LBP) that contains a fixed-proportion of eight strains of live probiotic bacteria which are intended to be administered orally.

Pouchitis is a condition which affects patients who had a surgical procedure to remove their colon.

The pouch anastomosis surgery, which removes the colon, creates an intestinal “J-Pouch” with a part of the lower intestine. Although the surgical procedure enables patients to have normal stools, one challenge is pouchitis in which the reservoir becomes inflamed.

ExeGi Pharma gets FDA orphan drug status for EXE-346 in pouchitis. Photo courtesy of ExeGi Pharma.

Presently, there are no approved treatments for managing the symptoms resulting from pouchitis or for helping patients in reaching remission.

EXE-346 has been designed to decrease the inflammation of the pouch and stop active disease flare-ups, said ExeGi Pharma, a  biotechnology company based in Rockville, Maryland.

Dr Paolo Gionchetti of the University of Bologna in Italy said: “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.

“I am pleased to see that the U.S. FDA has granted this product Orphan status because these patients need new treatment options to help maintain a normal quality of life.”