FRIDAY, SEPTEMBER 30, 2016

Soligenix starts clinical study for Crohn's disease treatment

Soligenix, Inc., announced on Wednesday that it will start phase 1 clinical studies for SGX203, a treatment for pediatric Crohn's disease.

Crohn's disease is a disorder that affects the gastrointestinal tract, which could be anywhere from the mouth to the anus, with most cases being in the lower part of the small intestine. The disease causes swelling in the infected areas, which causes pain and can make the intestines empty frequently.

"There are currently no FDA approved corticosteroid therapies for pediatric Crohn's disease and we believe that SGX203 has the potential to meet an important medical need in children with this serious illness," Kevin J. Horgan, senior vice president & chief medical officer of Soligenix, said.

The clinical study will look to determine pharmacokinetic and pharmacodynamics profile levels in young adults. The study will have 24 subjects and assessments of the study will be complete in June.

"Data from this study will be used to refine the (pharmacokinetic) model we have established with Dr. Barrett," Horgan said. "The PK model provides the justification for limited PK sampling in a subsequent clinical study in the pediatric population which is planned to commence later this year. The resultant PK data will play an important role in dose selection for Phase 3. The use of PK data in this way reflects the current state of the art in pediatric drug development, leveraging the maximum amount of information from the enrolled subjects."