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SecreFlo(TM): Better Patient Care through Improved Imaging of the Pancreas

Repligen is evaluating the use of SecreFlo(TM), synthetic human secretin, to improve visualization of pancreatic duct abnormalities when used in combination with magnetic resonance imaging (MRI). Detailed assessment of the pancreatic ducts is important in the diagnosis and treatment of diseases such as acute and chronic pancreatitis.

RG1068 is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion. Secretin signals the release of fluids into the ducts of the pancreas which results in increased delineation of the pancreatic ducts and improved MRI imaging.

Repligen's Phase 3 Development Program

Repligen has completed a positive Phase 3 study to evaluate the safety and efficacy of SecreFlo(TM) to improve MRI imaging 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 of 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 SecreFlo(TM)-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.

About Diagnosing Pancreatic Disease

Endoscopy has been used for many years by gastroenterologists to diagnose and treat diseases of the pancreas. There are risks associated with the use of endoscopy, which have generated interest in the development of safer non-invasive tests to diagnose pancreatic disorders. The use of SecreFlo(TM) in combination with a non-invasive procedure such as MRI can improve the detection of abnormalities and increase the diagnostic quality of the MRI image of the pancreas, leading to increased diagnostic confidence. The FDA has granted RG1068 Orphan Drug status and Fast Track Designation, a process designed to facilitate development and expedite the review of drugs that treat serious diseases and fill unmet medical needs. There are more than 300,000 MRI procedures conducted in the U.S. and Europe each year that could directly benefit by the addition of SecreFlo(TM)