Soligenix reports successful clinical trial of pediatric Crohn's disease drug
The SGX203 program has gained Fast Track and Orphan Drug connections from the U.S. Food and Drug Administration for oral BDP against pediatric Crohn's disease. The clinical trial, called "A Phase 1 Pharmacokinetic/and Young Adults," was conducted to study the pharmacokinetic and pharmacodynamic components of the drug.
In the study, 24 healthy males and females between the ages of 18 and 22 were assessed to refine the PK model and to observe the drug's safety profile. The drug was found to be safe and its PK profile is consistent with previous studies, which support a twice-a-day regimen.
"We have designed this program in collaboration with an expert in PK modeling and simulation, Jeffrey S. Barrett, PhD, FCP, from The Children's Hospital of Philadelphia," Senior Vice President & Chief Medical Officer of Soligenix Kevin J. Horgan said. "The PK data generated from this study will be used to refine the PK model we have established with Dr. Barrett. The refined model will provide the justification for limited PK sampling in the subsequent Phase 2/3 pediatric clinical study and will help inform the dose selection for the Phase 3 component of the study. 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."
Soligenix is a biopharmaceutical company that focuses on treating inflammatory diseases and countermeasures for biological threats.