PRINCETON, N.J., Soligenix, Inc. (OTCQB: SNGX) (Soligenix or the Company), a development stage biopharmaceutical company, announced today that the Food and Drug Administration (FDA) has completed its review and cleared the Investigational New Drug (IND) application for SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the induction treatment of pediatric Crohn's disease. Soligenix has previously received Orphan Drug Designation for oral BDP as a treatment for pediatric Crohn's Disease.
Clearance of the IND allows Soligenix to initiate a Phase 1/2 pharmacokinetic (PK)/pharmacodynamic (PD) study of SGX203 in healthy adolescents and young adults. The PK/PD data from this study will help inform dose selection for subsequent Phase 2/3 clinical studies. The trial is expected to be initiated in 2012.
"We are very excited to begin the clinical development of SGX203 which we believe may prove to have significant advantages relative to systemic steroids such as prednisone, which are currently administered to the vast majority of newly diagnosed pediatric Crohn's disease patients," stated Kevin Horgan, MD, Senior Vice President & Chief Medical Officer of Soligenix. "Our proprietary two-tablet system with immediate and delayed release capabilities allows for comprehensive treatment of a patient's disease regardless of its location in the gastrointestinal tract."
PR Newswire