Soligenix Inc (OTCBB:SNGX) announced that agreement has been finalized with the U.S. FDA on the design of a Phase 3 clinical study assessing its product, SGX203 in the cure of pediatric Crohn’s disease. It has previously been given both fast track and orphan drug designations from the FDA. The designations were approved for the treatment of pediatric Crohn’s Disease.

The candidate

Soligenix’s SGX203 is a formulation of BDP that utilizes a two-tablet delayed and immediate release system. It orally provides high mucosal concentrations of the “topical steroid” to both the lower and upper bowel walls. It is the reason behind its suitability for cure of Crohn’s disease in younger patients with gastrointestinal inflammation in the bowel areas as compared to adults who mainly have problem in lower area. Soligenix stated the treatment has lower adverse side effects that are frequently noticed with systemic steroid therapies.

The study

Soligenix disclosed that the upcoming pivotal Phase 3 study will be a double-blind, controlled, randomized, multi-national trial that intends to enroll about 150 subjects in 6-17 years of age group suffering with endoscopically stated mild to moderate Crohn’s disease. The study is expected to begin in 2H2015 with preliminary data available in 1H2017.

The expert view

Richard Straube, MD, the Chief Medical Officer of Soligenix, said that the team is excited to move forward with the pivotal study as an effort to improve the symptoms and signs of acute attacks of severe pediatric Crohn’s disease while reducing the harmful side-effects often noticed with systemic steroids. As of now, most of the patients suffering from mild to moderate form of Crohn’s disease are given off-label prednisone. There are many side-effects of treatment like bone demineralization and hindrance in normal growth. The management believes that candidate SGX203 can be prove to be a safer and effective treatment to control disease symptoms.

In last trading session, the stock price of Soligenix surged 2.23% to close the trading session at $1.83.