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%