Soligenix, Inc. (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 enrolled and treated all patients in the Phase 1 Study BDP-PCD-01; 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 SGX203 development program has previously received Fast Track and Orphan Drug designations from the US 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", was to further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the Company's unique proprietary oral BDP formulation. The study in healthy male and female adolescents and young adults provided important complementary data to that previously obtained, to enable the refinement of the PK model that is fundamental to the pediatric Crohn's disease development program. In addition, the study confirmed the safety profile observed in all previous clinical studies with oral BDP.
This study enrolled 24 subjects between the ages of 18-22, with all assessments completed in May 2013. Preliminary PK results indicate that the PK profile in this population is consistent with the profile established in previous studies in a broader population and supports a convenient twice a day dosing regimen. SGX203 administration (6 mg BDP twice daily over 7 days) was found to be safe and well-tolerated.
"We have designed this program in collaboration with an expert in PK modeling and simulation, Jeffrey S. Barrett, PhD, FCP, from The Children's Hospital of Philadelphia," stated Kevin J. Horgan, MD, Senior Vice President & Chief Medical Officer of Soligenix. "The PK data generated from this study will be used to refine the PK model we have established with Dr. Barrett. The refined model will provide the justification for limited PK sampling in the subsequent Phase 2/3 pediatric clinical study and will help inform the dose selection for the Phase 3 component of the study. 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."