ExeGi Pharma Announces FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic

ExeGi Pharma LLC, a company focused on developing live biotherapeutic (“LBP”) drugs and probiotics, announced today that its biologic drug candidate, EXE-346, has received an orphan drug designation from the U.S. Food and Drug Administration (FDA) for the prevention of disease relapse in pouchitis. This designation grants certain benefits to drugs and biological products intended to treat diseases which affect less than 200,000 patients in the U.S. EXE-346 is an LBP which contains a fixed-proportion of 8 strains of live probiotic bacteria which are intended for oral administration.

Pouchitis is a condition which impacts patients whom have had a surgical procedure to remove their colon. The surgery, called a pouch anastomosis, creates an intestinal “J-Pouch” with a portion of the lower intestine. While this procedure enables patients to pass stool normally, one challenge is pouchitis, a condition in which the reservoir becomes inflamed. While it’s not clear what causes pouchitis, studies suggest that an abnormal immune response to the bacterial microflora of the pouch may play a role in its development. The most common pouchitis symptoms are an increased number of bowel movements, abdominal pain, joint pain, cramps, and fever. There is currently no approved treatment for managing the symptoms associated with pouchitis or for helping patients reach remission. EXE-346 is intended to decrease this inflammation of the pouch and prevent active disease flare-ups. Antibiotics such as Ciprofloxacin are commonly used to treat the active form of the disease, suggesting a clear connection to a dysregulated pouch microbiome.

“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 U.S. 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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