Soligenix wins FDA clearance for SGX203 IND
Soligenix has received FDA clearance for SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) investigational new drug (IND) application for the induction treatment of pediatric Crohn's disease.
With the IND clearance, Soligenix is expected to commence a Phase 1/2 pharmacokinetic (PK)/pharmacodynamic (PD) study of SGX203 in healthy adolescents and young adults.
Soligenix senior vice president and chief medical officer Kevin Horgan said the SGX203 may prove to have significant advantages relative to systemic steroids such as prednisone.
"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," Horgan added.
The PK/PD study data is anticipated to help inform dose selection for subsequent Phase 2/3 clinical studies.
Latest News
Related News
Regulatory Affairs
Related Dates
2012> September
Related Industries
Pharmaceuticals and Healthcare
Related Insight
Suppliers Directory
Drug Research Drug Delivery Drug Discovery & Development
Contract Research & Services Clinical Trials Contract Research Contract Services
Automation IT & Software Laboratory Instrumentation
Inward Investment Packaging Regulatory Affairs
Regulatory Affairs Intelligence
API research into pharmaceutical companies and corporations Buy online from $200

Comments may be moderated for spam, obscenities or defamation.