PRINCETON, N.J., Sept. 6, 2012 /PRNewswire/ -- 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."
About Pediatric Crohn's Disease Crohn's disease is an ongoing disorder that causes inflammation of the gastrointestinal (GI) tract. Crohn's disease can affect any area of the GI tract, from the mouth to the anus, but it most commonly affects the lower part of the small intestine, called the ileum. The swelling caused by the disease extends deep into the lining of the affected organ. The swelling can induce pain and can make the intestines empty frequently, resulting in diarrhea. Because the symptoms of Crohn's disease are similar to other intestinal disorders, such as irritable bowel syndrome and ulcerative colitis, it can be difficult to diagnose. People of Ashkenazy Jewish heritage have an increased risk of developing Crohn's disease.Crohn's disease can appear at any age, but it is most often diagnosed in adults in their 20s and 30s. However, approximately 30% of people with Crohn's disease develop symptoms before 20 years of age. Pediatric Crohn's disease is a subpopulation of approximately 80,000 patients 0-19 years of age in the United States. Crohn's disease tends to be both severe and extensive in the pediatric population and a relatively high proportion (25-40%) of pediatric Crohn's patients have involvement of their upper gastrointestinal tract.