The SIMPLICITY study will evaluate the safety and efficacy of Sollpura powder for oral solution, supplied in sachets. This study will be conducted in 2 parts based on age.
The purpose of Part A of the SIMPLICITY study, which was completed in the fourth quarter of 2016, was to evaluate the safety of Sollpura powder for oral solution in subjects ≥ 7 years of age with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). On December 9, 2016, an independent Data Monitoring Committee evaluated the data from Part A and approved progression to Part B.
The purpose of Part B is to evaluate the safety and efficacy of Sollpura powder for oral solution in pediatric subjects 28 days up to 7 years of age with EPI due to CF based on observed coefficient of fat absorption. Before we proceed with Part B, we plan to amend the SIMPLICITY study to follow a similar dosing approach as the RESULT study and initiate enrollment in Part B after we report topline from the RESULT study.
Learn more about Sollpura.