Repligen Corporation (NASDAQ: RGEN) reported today positive top-line results from a Phase 3 study to evaluate the safety and efficacy of RG1068, synthetic human secretin, to improve magnetic resonance imaging (MRI) of the pancreas in patients with pancreatic disease using endoscopy (ERCP) as a diagnostic reference. The study's co-primary endpoints were achievement of a statistically significant improvement in sensitivity of detection of abnormalities with a loss in specificity of less than 7.5% by two of the three central radiologists reading the MRI images. In this study, all three radiologists achieved a clinically and statistically significant improvement in sensitivity (all radiologists p<0.0001) with minimal loss in specificity (all radiologists <7.5%). In addition, the RG1068-MRI images showed highly significant improvements on image quality (all radiologists p<0.0001), and confidence in the diagnostic findings (all radiologists p<0.0001), when compared to MRI alone. There were no serious adverse events (SAEs) or unscheduled days of hospitalization associated with the RG1068-MRI procedures compared to 55 SAEs and 236 days of unscheduled hospitalization associated with the ERCP procedures.
“This study demonstrated that RG1068 improves the identification of patients with pancreatic disease and allows the radiologist to render a more highly confident diagnosis to the gastroenterologist”
"This study demonstrated that RG1068 improves the identification of patients with pancreatic disease and allows the radiologist to render a more highly confident diagnosis to the gastroenterologist," stated Dr. Stuart Sherman, M.D., Professor of Medicine and Radiology at Indiana University School of Medicine and Clinical Director of Gastroenterology and Hepatology and the principal investigator of this study. "RG1068 has the potential to significantly increase a physician's ability to confidently triage their patients, to improve planning for indicated ERCP and pancreatic surgery and will be an important aid in avoiding unnecessary ERCP procedures which are potentially harmful for patients."
"We are pleased with the strongly positive results of this study which support the use of RG1068-MRI as a safe, non-invasive approach to the identification of pancreatic abnormalities," stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. "We intend to request a meeting with the FDA to review these results and to discuss our plan to file a New Drug Application."
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