FDA Orphan Drug Designation for EXE-346 Live Biotherapeutic standard
November 12, 2020 (Rockville, Maryland): 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 who have had a surgical procedure to remove their colon. The surgery, called a pouch anastomosis, creates an intestinal “J-Pouch” ...
Continue Reading