WALTHAM, Mass.--(BUSINESS WIRE)--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.
