Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Inclusion Criteria: * Male and female patients aged ≥12 years from the date of informed consent * Confirmed diagnosis of CF at screening * Confirmed EPI by historical (within past 12 months) CFA \<70% without use of PERTs or current fecal elastase \<50 µg/g stool at screening * Currently receiving PERT with a commercially available pancreatic enzyme * Currently on stable treatment with proton pump inhibitors or H2 receptor antagonists * Clinically stable condition without evidence of acute respiratory disease or any other acute condition Exclusion Criteria: * History of fibrosing colonopathy * History of significant bowel resection, in the opinion of the investigator, or solid organ transplant * History of being refractory to pancreatic enzyme replacement * Current diagnosis or history of distal intestinal obstruction syndrome * Current diagnosis of small intestinal bacterial overgrowth, ileus or acute abdomen * A body mass index percentile \<10%