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GT Biologics has been granted orphan drug designation by FDA Office of Orphan Product Development for Thetanix,
GT Biologics, a company developing live biotherapeutics for the treatment of autoimmune diseases, has been granted orphan drug designation by FDA’s Office of Orphan Product Development for Thetanix (bacteroides thetaiotaomicron). Thetanix received orphan designation for pediatric Crohn’s disease.
Pediatric Crohn’s disease is a severe condition with additional consequences and health impacts such as impaired development and growth retardation. The bacterial component in Thetanix is depleted in Pediatric Crohn’s. Thetanix possesses properties for restoring the gut microbiota and is anti-inflammatory, which allows Thetanix to improve the symptoms associated with Crohn’s.
Source: GT Biologics