Clinical-stage biopharmaceutical company Soligenix has initiated a Phase I study of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) to treat paediatric Crohn's disease.
SGX203 is a two-tablet delivery system of BDP designed for oral use that allows for administration of immediate and delayed-release BDP throughout the small bowel and the colon.
The FDA previously granted orphan drug designation to SGX203 for the treatment of paediatric Crohn's disease in addition to fast-track designation.
Soligenix senior vice president and chief medical officer Dr Kevin Horgan said; "There are currently no FDA-approved corticosteroid therapies for paediatric Crohn's disease and we believe that SGX203 has the potential to meet an important medical need in children with this serious illness."
The study is designed to determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile of oral BDP in healthy young male and female adolescents.
A total of 24 subjects will be enrolled in the study, which is expected to be completed in June 2013.