The SIMPLICITY study is evaluating the safety and efficacy of Sollpura powder for oral solution, supplied in sachets. This study is designed in 2 parts based on age.
The purpose of Part A of the SIMPLICITY study, which was completed in Q4 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 proceeding with Part B, we will first verify the higher dosing strategy in older children and adults with topline data from the RESULT study. We plan to then 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.