12-Month Safety Data of ZENPEP^® and Growth Parameter Data in Infants With CF¹*

AE=adverse event.

A 12-month, open-label, follow-on study to gather data on the long-term safety of ZENPEP and to track growth parameters in infants 1 to 12 months of age with CF (N=15). The primary endpoints were the frequency, duration, and severity of treatment-emergent adverse events during long-term treatment with ZENPEP. The secondary endpoints were the effects of the long-term treatment with ZENPEP on growth parameters, including weight, length, weight-for-age percentile, length-for-age percentile, weight-for-length percentile, and z scores. The dose of ZENPEP was adjusted during the study to accommodate weight gain; ZENPEP capsules were opened, and the contents were mixed with a small amount of apple juice or applesauce and administered orally. Infants up to 12 months of age received 2,000 to 4,000 lipase U/120 mL of formula or per breast-feeding.¹

The table presents the number of distinct patients with possible or probable AEs. The study also captured unrelated AEs (not shown).