EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency  Jamie L. Wooldridge, James E. Heubi, Rodolfo Amaro-Galvez, Steven R. Boas, Kathryn V. Blake, Samya Z. Nasr, Barbara Chatfield, Susanna A. McColley, Marlyn S. Woo, Karen A. Hardy, Richard M. Kravitz, Cristina Straforini, Marco Anelli, Candace Lee  Journal of Cystic Fibrosis  Volume 8, Issue 6, Pages 405-417 (December 2009) DOI: 10.1016/j.jcf.2009.07.006 Copyright © 2009 European Cystic Fibrosis Society Terms and Conditions

Fig. 1 Flow of the randomized study comparing EUR-1008 to placebo in patients age ≥7years. The study included a washout period prior to open-label dose titration/stabilization, followed by randomized treatment, an open-label normalization period, crossover treatment, and a second open-label normalization period prior to study end. Journal of Cystic Fibrosis 2009 8, 405-417DOI: (10.1016/j.jcf.2009.07.006) Copyright © 2009 European Cystic Fibrosis Society Terms and Conditions

Fig. 2 Flow of the open-label, supplemental study in children age <7years. During a screening period of up to 14days, patients continued taking their previous pancreatic enzyme product (PEP), which they discontinued, along with any medications altering gastric pH or motility, upon entering the study. The study period consisted of a 7-day dose stabilization period using EUR-1008, followed by a 7-day treatment period with the study drug. PEP: pancreatic enzyme product. Journal of Cystic Fibrosis 2009 8, 405-417DOI: (10.1016/j.jcf.2009.07.006) Copyright © 2009 European Cystic Fibrosis Society Terms and Conditions

Fig. 3 Plots of the individual patient values of CFA during placebo and EUR-1008. Bars on the far left and right of figure indicate the least-squares (LS) means and the standard error (SEM) of CFA during placebo (62.8±2.6%) vs. CFA during EUR-1008 treatment (88.3±2.6%). All patients had fecal elastase (monoclonal assay) of <100µg/g stool at screening. CFA (coefficient of fat absorption); SEM (standard error of the mean). Journal of Cystic Fibrosis 2009 8, 405-417DOI: (10.1016/j.jcf.2009.07.006) Copyright © 2009 European Cystic Fibrosis Society Terms and Conditions