Soligenix, a development stage biopharmaceutical company based in Princeton, N.J., announced that its drug SGX203, for the treatment of mild-to-moderate pediatric Crohn's disease, has received Fast Track designation from the FDA.
SGX203 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. SGX203 is a two tablet delivery system (immediate and delayed release) of BDP specifically designed for oral use that allows for delivery of BDP throughout the small bowel and the colon. The FDA previously awarded SGX203 Orphan Drug designation for the treatment of pediatric Crohn's disease.
"There are no FDA approved corticosteroid therapies for the induction treatment of Crohn's disease in the pediatric population," said Christopher J. Schaber, PhD, president and CEO, Soligenix. "The FDA's action in granting Fast Track designation is an indication of SGX203's potential to address this debilitating, unmet medical need. We look forward to working closely with the FDA to potentially expedite the development and NDA review process."