SGX203 contains an active corticosteroid, beclomethasone 17,21-dipropionate (BDP), that targets local inflamed tissue.
The oral two tablet delivery system used for immediate and delayed release is designed for the BDP delivery all through the small bowel and the colon.
Soligenix president and chief executive officer Christopher Schaber said no FDA approved corticosteroid therapies are available for induction treatment of Crohn’s disease in the pediatric population.
"The FDA’s action in granting fast track designation is an indication of SGX203’s potential to address this debilitating, unmet medical need," Schaber added.
"We look forward to working closely with the FDA to potentially expedite the development and NDA review process."
The drug product earlier received FDA orphan drug designation as pediatric Crohn’s disease medication.