Soligenix announced today that an agreement has been reached with the US Food and Drug Administration (FDA) on the design of a pivotal Phase 3 clinical trial evaluating SGX203 in the treatment of paediatric Crohn’s disease.
SGX203 (oral beclomethasone 17,21-dipropionate or BDP) has previously been granted both orphan drug and fast track designations from the FDA for the treatment of Crohn’s Disease in the paediatric population.
SGX203 is a proprietary formulation of BDP that uses a two-tablet immediate and delayed release system to orally deliver high mucosal concentrations of the topical steroid to both the upper and lower bowel walls. This makes SGX203 particularly well suited for Crohn’s disease in younger patients that are reported to have gastrointestinal inflammation in both areas of the bowel as opposed to adults who have mainly lower (colon) involvement. Oral BDP has a limited systemic absorption into the blood stream, decreasing the potential for the development of adverse side-effects frequently seen with systemic steroid therapies, like prednisone. These side effects include bone demineralisation and interference with normal growth, which are particularly concerning in children.
Primary data from the SGX203 trial anticipated for release in the first half of 2017
The upcoming pivotal Phase 3 study will be a double-blind, randomized, controlled, multi-national trial and will seek to enroll approximately 150 subjects 6-17 years of age with endoscopically proven mild to moderate Crohn’s disease. The trial will compare the rates of improvement of the signs and symptoms of Crohn’s disease after 8 weeks of treatment among subjects randomized to one of three SGX203 dose. Subjects will be followed for an additional 6 months after the completion of treatment. The primary clinical efficacy endpoint of the trial will compare the percentage of subjects in each of the three dose groups having resolved their signs and symptoms after an 8-week course of treatment. The trial is anticipated to begin in the second half of 2015 with primary data available in the first half of 2017.
“We are excited to move forward with this trial in an effort to improve the signs and symptoms of acute attacks of paediatric Crohn’s disease while minimizing the deleterious side-effects often seen with systemic steroids,” stated Richard Straube, MD, Chief Medical Officer of Soligenix. “Currently, most paediatric 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.”
