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.
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