Positive DSMB review of Phase III SOLUTION clinical trial
The DSMB voted that the study could continue without changes.
The study is evaluating the effectiveness of Sollpura (liprotamase) effectiveness versus existing porcine-derived, enterically-coated pancreatic enzyme replacement therapy (PERT) in patients who have exocrine pancreatic insufficiency (EPI) due to cystic fibrosis.
Sollpura consists of a mixture of lipase, protease and amylase digestive enzymes. It does not contain any pig (porcine) ingredients. It is manufactured as a powder and inserted into capsules. It is stable in the digestive system and does not require an enteric coating.
The study is comparing Sollpura to the porcine-based PERT by evaluating the changes in the coefficient of fat absorption (CFA). During the first two weeks of the study and in the extension period, the individualized doses of Sollpura and the porcine-based PERT may be adjusted if the patient shows clinical signs of malabsorption.
SOLUTION is still recruiting participants at https://clinicaltrials.gov/ct2/show/NCT02279498. Participants must be age seven or older with a diagnosis of cystic fibrosis and a minimum CFA while on PERT therapy. The study includes an estimated 126 participants at 54 locations in the U.S., Canada, Czech Republic, Hungary, Israel, Poland and Spain.