Efficacy

In a clinical trial, the right dose of ZENPEP® helped patients absorb nutrients and provided symptom relief1,2

Bar chart showing the mean difference in CFA and CNABar chart showing the mean difference in CFA and CNA
  • Results achieved without the use of PPIs, H2-blockers, or motility agents2
  • Vitamin A and E absorption significantly improved with ZENPEP vs placebo (P<0.001)2
  • The unique formulation of ZENPEP is designed to mimic typical exocrine pancreatic function1

CF=cystic fibrosis; CFA=coefficient of fat absorption; CI=confidence interval (the range in which we are 95% sure our mean value lies); CNA=coefficient of nitrogen absorption; EPI=exocrine pancreatic insufficiency; PPI=proton pump inhibitor.

* A randomized, double-blind, placebo-controlled, 2-treatment, crossover study (ZENPEP Study 1) in patients with EPI due to CF aged 7 to 23 years. Patients were randomized to ZENPEP or placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for 6 to 7 days. All patients consumed ≥100 g of fat per day. The primary efficacy endpoint was the mean difference in CFA between ZENPEP and placebo, which was measured from a 72-hour stool collection during both treatments. The use of enzymes other than ZENPEP and drugs affecting gastric pH or motility was not allowed during the trial.1,2

One patient did not have fecal fat and nitrogen readings while on placebo.2

91% of patients achieved a CFA of 80% or higher with ZENPEP2

  • 50% achieved a near-normal CFA above 90%2‡

Normal CFA is defined as 93% or higher by the ACG.3

ZENPEP provided relief for a range of symptoms2

  • Decreased EPI symptoms can help patients eat with less discomfort4

Significant reduction in EPI-related GI symptoms with ZENPEP vs placebo

ZENPEP symptom reductions ZENPEP symptom reductions

GI=gastrointestinal.

Percentages were derived from actual numbers in referenced data. P values were taken directly from reference.

Statistically significant improvement in mean Total Symptoms Index (TSI) score|| was demonstrated with ZENPEP vs placebo (P=0.015).5

||TSI assesses overall improvement in the clinical symptoms of EPI.

References: 1. ZENPEP. Package insert. Aimmune Therapeutics, Inc. Bridgewater, NJ; October 2023. 2. Wooldridge JL, Heubi JE, Amaro-Galvez R, et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009;8(6):405-417. doi:10.1016/j.jcf.2009.07.006 3. Gardner TB, Adler DG, Forsmark CE, Sauer BG, Taylor JR, Whitcomb DC. ACG Clinical Guideline: chronic pancreatitis. Am J Gastroenterol. 2020;115(3):322-339. doi:10.14309/ajg.0000000000000535 4. Othman MO, Harb D, Barkin JA. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72(2):e13066. doi:10.1111/ijcp.13066 5. Data on file. CSR-1008 Nestlé Health Science.