Zentase met all primary and secondary endpoints in two phase III trials. The studies were designed to determine whether the product candidate could alleviate serious malabsorption associated with EPI in both a pediatric and an older patient population.
Study results showed a clinically and statistically significant increase in the coefficient of fat absorption (CFA) in patients treated with Zentase. The mean percentage of CFA in patients receiving Zentase was 88.3% versus 62.8% in patients receiving placebo. Treatment guidelines suggest that the CFA should be at least 85% in cystic fibrosis patients.
The FDA has granted fast track status for Zentase for the treatment of EPI. The company intends to file for FDA approval during the second quarter of 2007.
According to the FDA, many of the current enzyme products contain overfill to compensate for product instability during shelf life, which can lead to variability in dosing. Zentase does not require overfill. Currently, there are no FDA approved PEPs for the treatment of EPI on the market in the US.