ABERDEEN, Scotland--(BUSINESS WIRE)--GT Biologics, a company developing Live Biotherapeutics for the treatment of autoimmune diseases, announced today that it has been granted Orphan Drug Designation by the U.S Food and Drug Administration (FDA) Office of Orphan Product Development for Thetanix™, Bacteroides Thetaiotaomicron, the company’s lead candidate. Thetanix™ received Orphan Designation for paediatric Crohn’s disease.
Paediatric 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 Paediatric Crohn’s. Thetanix™ possesses imperative properties for restoring the gut microbiota and is anti-inflammatory, as such Thetanix™ can ameliorate the symptoms associated with Crohn’s.
“Orphan Designation from the FDA allows us to accelerate the development of Thetanix™, providing us with the ability to deliver the drug to the market faster in order to treat this severe unmet medical need,” Mr Thomas Engelen, Chairman of GT Biologics. “Current treatments for Paediatric Crohn’s are immune-suppressive and are accompanied by severe side effects; Thetanix™ proffers an alternative treatment which is naturally derived from the human microbiota”
Paediatric Crohn’s Disease
Crohn’s disease is an inflammatory disease of the intestines that may affect any part of the gastrointestinal tract, causing a wide variety of symptoms. The disease is an autoimmune disease, in which the body's immune system attacks the gastrointestinal tract, causing inflammation. Loss of immunological tolerance to the gut microbiota is an important factor driving this disease.
Paediatric Crohn’s is clinically distinct from adult Crohn’s. Patients are at risk of malnutrition for many reasons, including decreased food intake and malabsorption. In children, this malnutrition can lead to growth stunting and a significant delay in the onset of puberty.