FDA Authorizes Phase 3 Clinical Trial for Pediatric Crohn's Disease Therapy

Soligenix, Inc., a late-stage biopharmaceutical company, recently announced that the US Food and Drug Administration (FDA) authorized a pivotal Phase 3 clinical trial to assess the efficacy of novel drug SGX203, a pediatric Crohn's disease (CD) therapy.

Soligenix, Inc., a late-stage biopharmaceutical company, recently announced that the US Food and Drug Administration (FDA) authorized a pivotal Phase 3 clinical trial to assess the efficacy of novel drug SGX203, a pediatric Crohn’s disease (CD) therapy.

An oral formulation of the highly potent corticosteroid beclomethasone 1721-dipropionate (BDP), SGX203was designed in a 2-tablet system to distribute high steroid concentrations in both the inflamed upper and lower bowel walls of patients with CD.

SGX203, which had been previously been granted the orphan drug and fast track designations by the FDA for pediatric CD, has been shown to be safe in humans thus far.

The new pivotal Phase 3 clinical trial will enroll approximately 150 participants aged 6 to 17 years with existing diagnoses of mild to moderate CD.

Three separate doses and drug efficacy of SGX203 will be evaluated after 8 weeks of treatment and 6 months later, with the primary clinical endpoint focused on the improvement of disease symptoms.

The trial is slated to begin in the latter half of 2015, so the initial results would theoretically be available by the beginning of 2017.

Richard Straube, Chief Medical Officer of Soligenix, said, “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.”