FDA Grants Orphan Drug Status to Seres for Pediatric Ulcerative Colitis Therapy

FDA Grants Orphan Drug Status to Seres for Pediatric Ulcerative Colitis Therapy
Seres Therapeutics has secured an orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for SER-287, its therapy to treat ulcerative colitis in children. ODD offers companies incentives to develop therapies designed to treat diseases affecting fewer than 200,000 Americans. SER-287 is a new kind of drug made up of bacterial spores, or dormant bacteria that act as seeds, only multiplying when conditions are right. The spores in SER-287 produce bacteria that help the intestines, where they multiply and replace bacteria that contribute to UC. SER-287 won its ODD status on the basis of a recent placebo-controlled Phase 1b trial (
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