Soligenix, a clinical stage biopharmaceutical company developing products to treat serious gastrointestinal diseases, has enrolled and treated all 24 patients in the phase 1 Study BDP-PCD-01, the first clinical study for development of SGX203 (oral BDP) for the treatment of pediatric Crohn’s disease.
The objective of Study BDP-PCD-01 was to further characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profile of the company’s proprietary oral BDP formulation. Soligenix reports that the data was complementary to results previously obtained and confirms the safety profile observed in all previous clinical studies with oral BDP.
This study enrolled subjects between the ages of 18-22. The company said preliminary PK results indicate that the PK profile in this population matches the profile established in previous studies in a broader population and supports a twice-a-day dosing regimen. SGX203 was found to be safe and well-tolerated.
“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,” Kevin J. Horgan, MD, senior vice president and chief medical officer of Soligenix stated in the press release. “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 will use the PK data generated from the study to refine the PK model the company has established with Dr. Barrett, and is expected to justify limited PK sampling in the phase 2/3 pediatric clinical study and help determine the dose selection for the phase 3 study.
The SGX203 development program previously received Fast Track and Orphan Drug designations from the U.S. FDA for oral BDP as a treatment for pediatric Crohn’s disease.
For more information, visit www.soligenix.com
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