Soligenix, a clinical stage biopharmaceutical company focused on inflammatory diseases and biodefense countermeasures, has initiated the first clinical study for development of SGX203 (oral beclomethasone 17, 21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease. The program has previously received Fast Track and Orphan Drug designations from the FDA for oral BDP as a treatment for pediatric Crohn's disease.
The objective of study BDP-PCD-01 is to determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile of oral BDP in healthy young male and female adolescents and adults. This study will enroll 24 subjects, with assessments to be completed in June 2013.
SGX203 contains BDP, a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the U.S. and worldwide since the early 1970s as the active pharmaceutical ingredient in inhalation products for the treatment of patients with allergic rhinitis and asthma. SGX203 is a two tablet delivery system of BDP specifically designed for oral use that allows for administration of immediate and delayed release BDP throughout the small bowel and the colon.
"There are currently no FDA approved corticosteroid therapies for pediatric Crohn's disease and we believe that SGX203 has the potential to meet an important medical need in children with this serious illness," said Kevin J. Horgan, MD, senior vice president and CMO of Soligenix. "Data from this study will be used to refine the PK model we have established with Dr. Barrett. The PK model provides the justification for limited PK sampling in a subsequent clinical study in the pediatric population which is planned to commence later this year. The resultant PK data will play an important role in dose selection for phase III.”