DP-b99 in the Treatment of Acute High-risk Pancreatitis

Inclusion Criteria: * Male or female subject. * Age 18 years or higher. * First in a lifetime episode of acute pancreatitis. * Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis * History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening). * BISAP score of 3 or higher * Study treatment initiation is possible within 48 h of symptom onset * Ability to provide informed consent Exclusion Criteria: * Drug-induced, viral, hereditary or post-ERCP pancreatitis. * Recurrent episode of pancreatitis. * CT evidence of pancreatic necrosis at study entry. * Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ. * Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis). * High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week. * Class II or greater New York Heart Association heart failure. * Oxygen-dependent chronic obstructive pulmonary disease (COPD). * Cirrhosis of the liver. * Severe anemia (hemoglobin less than 8 g/dL). * Hematocrit below 35 % or above 45 % at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset). * Serum alanine aminotransferase above 250 IU/L at study entry. * Clinical suspicion of ascending cholangitis at study entry. * Active gastrointestinal bleeding. * Current malignancy not in remission (other than basal cell carcinoma of skin). * Altered mental status. * Current breastfeeding or pregnancy. * Female of childbearing potential (less than 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures * Known hypersensitivity to any component of the investigational product. * Dependent relationship with the investigator or the sponsor. * Participation in an investigational drug study during this clinical trial or within 30 days prior to start of this clinical trial