Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, announced today that it 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 U.S. Food and Drug Administration (FDA) for oral BDP as a treatment for pediatric Crohn's Disease.
The objective of Study BDP-PCD-01, entitled "A Phase 1 Pharmacokinetic/Pharmacodynamic Study of Oral Beclomethasone 17,21-Dipropionate (BDP) in Healthy Adolescents and Young Adults", 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.
The program has been designed in collaboration with an expert in PK modeling and simulation, Jeffrey S. Barrett , PhD, FCP. Dr. Barrett is Director of both the Laboratory for Applied PK/PD and also the Pediatric Pharmacology Research Unit at The Children's Hospital of Philadelphia. He is also Professor of Pediatrics at the University of Pennsylvania Medical School.
"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," stated Kevin J. Horgan , MD, Senior Vice President & Chief Medical Officer 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 3. The use of PK data in this way reflects the current state of the art in pediatric drug development, leveraging the maximum amount of information from the enrolled subjects."