FDA Authorizes Soligenix’s Pivotal Phase 3 Clinical Trial for Pediatric Crohn’s Disease Therapy

FDA Authorizes Soligenix’s Pivotal Phase 3 Clinical Trial for Pediatric Crohn’s Disease Therapy

shutterstock_257882090Biopharmaceutical company Soligenix, Inc. recently announced in a news release that the U.S. Food and Drug Administration (FDA) has authorized a pivotal Phase 3 clinical trial to assess the efficacy of its drug SGX203 as a therapy for pediatric Crohn’s disease.

Pediatric Crohn’s disease is a chronic inflammatory bowel disease characterized by inflammation across the lining of the gastrointestinal (GI) tract. The major symptoms include abdominal pain, GI bleeding, diarrhea, malabsorption, and weight loss. Children often also experience bone demineralization, a decrease in growth rate and a delay in puberty. Pediatric Crohn’s disease is estimated to affect around 80,000 children in both United States and Europe.

SGX203 is an oral formulation of the highly potent corticosteroid beclomethasone 17,21-dipropionate (BDP), and it was designed in a two-tablet system to deliver high steroid concentrations in both the inflamed upper and lower bowel walls in Crohn’s disease patients. BDP has a local effect in the inflamed tissue and a limited absorption from the mucosal surfaces into the bloodstream. SGX203 has been previously granted by the FDA the orphan drug and fast track designations for the treatment of pediatric Crohn’s disease and has so far been proven safe in humans.

The new pivotal Phase 3 clinical trial will be a multi-national randomized, double-blind, controlled study that will enroll around 150 participants aged 6 to 17 years old with a proven diagnosis of mild to moderate Crohn’s disease. SGX203 will be tested in three different doses and drug efficacy will be evaluated after 8 weeks of treatment and 6 months later. The primary clinical efficacy endpoint is the improvement or resolution of disease symptoms. The trial is expected to start in the second half of 2015 and the initial results should be available in the first half of 2017.

“We are pleased to have FDA agreement on this Phase 3 protocol after having worked closely with the FDA on its design,” said the President and Chief Executive Officer of Soligenix Dr. Christopher Schaber.

“We are excited to move forward with this trial in an effort to improve the signs and symptoms of acute attacks of pediatric Crohn’s disease while minimizing the deleterious side-effects often seen with systemic steroids,” concluded the Chief Medical Officer of Soligenix Dr. Richard Straube. “Currently, most pediatric patients with mild to moderate active disease are treated with off-label prednisone. The side effects of prednisone, such as bone demineralization and interference in normal growth, are particularly concerning in children. We believe that SGX203 has the potential to deliver adequate doses of BDP to the GI tract with markedly reduced systemic toxicity. This, in turn, may offer physicians and patients an effective, and safer, therapy to control disease symptoms.”

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