Soligenix, a clinical stage biopharmaceutical company focused on developing products to treat inflammatory diseases and biodefense countermeasures where there remains an unmet medical need, has enrolled and treated all patients in the phase I study BDP-PCD-01, a 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 previously has received Fast Track and Orphan Drug designations from the FDA.
The objective of the study was to further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the company's proprietary oral BDP formulation. The study in healthy male and female adolescents and young adults provided complementary data to that previously obtained and confirmed the safety profile observed in all previous clinical studies with oral BDP.
This study enrolled 24 subjects between the ages of 18 to 22, with all assessments completed in May. Preliminary 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 twice-daily dosing regimen. SGX203 administration (6mg BDP twice daily over seven days) was found to be safe and well-tolerated.
“The refined model will provide the justification for limited PK sampling in the subsequent phase II/III pediatric clinical study and will help inform the dose selection for the phase III component of the study,” said Kevin J. Horgan, M.D., senior vice president and chief medical officer of Soligenix.