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%