The Phase 3 SOLUTION study was designed to evaluate the non-inferiority of Sollpura when compared to approved, porcine-derived, enteric-coated pancreatic enzyme replacement therapy (PERT) in patients with exocrine pancreatic insufficiency due to cystic fibrosis. The study enrolled 128 patients who were well controlled on stable PERT at screening, as demonstrated by a coefficient of fat absorption (CFA) of at least 80%. The topline data announced in December 2016 showed that the study narrowly missed the CFA non-inferiority margin of the primary modified Intent to Treat population (mITT) analysis by 1%; however, by additional pre-specified analyses of CFA (mITT-Baseline Observation Carried Forward and Per Protocol), Sollpura met the non-inferiority criterion. The study also confirmed that the ratio of the three enzymes in Sollpura provided an appropriate response in the Coefficient of Nitrogen Absorption (CNA), a key indicator of protein absorption.
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