Successful Phase 1 clinical trial for paediatric Crohn's disease treatment announced

The success of Soligenix Inc's Phase 1 Study BDP-PCD-01 clinical trial has been announced by the company. The trial is the first to test the new drug, SGX203, for the treatment of paediatric Crohn's disease.

The development programme for SGX203 has been 'Fast Tracked' by the US Food and Drug Administration (FDA), allowing the 'Phase 1 Pharmacokinetic/Pharmacodynamic Study of Oral Beclomethasone 17,21-Dipropionate (BDP) in healthy Adolescents and Young Adults' to take place faster than other trials and for the results to be collated quicker.

The study has taken place to assess the pharmacodynamic (PD) and pharmacokinetic (PK) components of SGX203. The results of the trial will help to further the refinement of the PK aspects of the drug, which is one of the most important factors in the treatment of paediatric Crohn's disease.

The Phase 1 study also confirmed the most effective drug regimen - twice a day - as found in previous studies. The study also confirmed the safety aspects of oral BDP that were found in clinical trials that have been performed in the past.

Kevin J Horgan, senior vice president and chief medical officer of Soligenix Inc, said: "We have designed this program in collaboration with an expert in PK modelling and simulation, Jeffrey S. Barrett, PhD, FCP, from The Children’s Hospital of Philadelphia. 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 paediatric 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 paediatric drug development, leveraging the maximum amount of information from the enrolled subjects.”

The Phase 1 clinical trial involved 24 participants, both male and female, between the ages of 18 and 22.