Sollpura: Ph III SOLUTION data
Top-line data from the open-label, international Phase III SOLUTION trial in 129 patients showed that oral Sollpura missed the primary endpoint of non-inferiority to oral porcine-derived pancreatic enzyme replacement therapy (PERT) in the change from baseline in CFA following 7 weeks of therapy (95% CI: -16%, -8%). The non-inferiority margin was 15%. Sollpura did meet the non-inferiority criterion for CFA in the per protocol (PP) and modified intent-to-treat (ITT)-baseline observation carried forward populations. Sollpura also met the secondary endpoint of non-inferiority to PERT in the change from baseline in coefficient of nitrogen absorption. Sollpura was generally well tolerated, but led to a higher frequency of symptoms related to malabsorption vs. PERT. The starting dose of Sollpura or PERT in the trial was individually chosen based on the number of lipase units in the patient’s pre-study PERT regimen. Patients were then allowed to increase their dose by up to 25% at the end of each week during the first 2 weeks based on clinical signs of malabsorption up to a maximum daily dose of 10,000 lipase units/kg. The trial includes a 12-week, open-label extension...