SGX203 is specifically formulated for oral administration as a single product consisting of two tablets. One tablet releases BDP in the upper gastrointestinal (GI) tract and the other tablet releases BDP in the lower GI tract.
We have initiated the SGX203 development program for pediatric Crohn’s disease. The objective of developing SGX203 for pediatric Crohn’s is to make available a corticosteroid option with less toxicity than the current standard therapy prednisone.
SGX203 in pediatric Crohn’s disease has been awarded Orphan Drug and Fast Track Designations by the FDA.
About Pediatric Crohn’s Disease
Crohn’s disease is a chronic disorder that can cause inflammation of any part of the gastrointestinal tract. It most commonly affects the lower part of the small intestine called the ileum. The inflammation associated with the disease extends deep into the lining of the intestine and is typically associated with pain and diarrhea.
Though Crohn’s disease can appear at any age, it is most often diagnosed in young adults in their 20s and 30s. Approximately 30% of people with Crohn’s disease develop symptoms before 20 years of age. Pediatric Crohn’s disease affects approximately 80,000 patients in the United States. Crohn’s disease tends to be both severe and extensive in the pediatric population with a relatively high proportion (~40-50%) of pediatric Crohn’s patients having involvement of their upper GI tract, proximal to the ileum. Crohn’s disease presents special challenges for children and teens as the disease can stunt growth, delay puberty, and weaken bones.
Current therapy for pediatric Crohn’s disease consists of off-label use of systemic corticosteroids such as prednisone, immunosuppressive drugs such as 6-mercaptopurine and methotrexate and biologics such as Remicade®. Of these, only Remicade® is approved with an indication for treatment of children with moderately to severely active disease who have had an inadequate response to conventional therapy.