By Grant Zeng, CFA A copy of the full research report can be downloaded here >> Soligenix Report
Phase I Clinical Study with SGX203 for the Treatment of Pediatric Crohn's Disease has been completed
On June 28, 2013, Soligenix (OTC BB:SNGX) announced that it has enrolled and treated all patients in the Phase I Study BDP-PCD-01; the first clinical study for development of SGX203 (oral beclomethasone 17,21-dipropionate or oral BDP) for the treatment of pediatric Crohn's disease.
SGX203 has received Fast Track and Orphan Drug designations from the US FDA for the treatment of pediatric Crohn's disease.
As a reminder, Soligenix initiated the Phase I clinical study on May 15, 2013. The objective of the Phase I study BDP-PCD-01 is to determine the pharmacokinetic (PK) and pharmacodynamic (PD) profile of SGX203 in healthy young male and female adolescents and adults.
This study enrolled 24 subjects between the ages of 18-22, with all assessments completed in May 2013. Preliminary PK results indicate that the PK profile in this population is consistent with the profile established in previous studies in a broader population and supports a convenient twice a day dosing regimen. SGX203 administration (6 mg BDP twice daily over 7 days) was found to be safe and well-tolerated.
The study in healthy male and female adolescents and young adults provided important complementary data to that previously obtained, to enable the refinement of the PK model that is fundamental to the pediatric Crohn's disease development program. In addition, the study confirmed the safety profile observed in all previous clinical studies with oral BDP.
Phase II/III trial is planned
Soligenix plans to start Phase II/III trial of SGX203 in 2H 2013. Primary endpoint data are expected in 2H 2014.
The PK data generated from the Phase I study will be used to refine the PK model previously established with Dr. Jeffrey S. Barrett, PhD, FCP, from The Children's Hospital of Philadelphia. The refined model will provide the justification for limited PK sampling in the planned Phase II/III pediatric clinical study and will help inform the dose selection for the Phase III component of the study.
There is currently no cure for Crohn's disease, and there is no one treatment that works for everyone. Drug therapies usually include anti-inflammatory drugs, immune system suppressors and antibiotics. There are currently no FDA approved corticosteroid therapies for pediatric Crohn's disease. 80% of patients with Crohn’s disease are treated with steroids off-label as first-line therapy, which may suppress adrenal function and result in growth retardation. Remicade is the only approved product in pediatric Crohn’s disease in the US, which is used in 30% of patients within first year of diagnosis. However, Remicade carries a black box warning for potential malignancy (T cell lymphoma). Two biologics, Cimzia and Tysabri and one corticosteroid Entocort (budesonide) are on the market to treat Crohn’s disease in adult patients, and are currently in trials in pediatric patients.
SGX203 is designed to block inflammation of Crohn’s disease throughout the GI tract and is positioned as a corticosteroid option with less toxicity than the current standard systemic steroid therapy – prednisone.
We believe SGX203 has the potential to meet an important medical need in children with this serious illness.
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A copy of the full research report can be downloaded here >> Soligenix Report