Repligen reports Phase 3 RG1068 data: Improved MRI imaging of pancreatic and biliary disease expected to reduced ERCP procedures

According to a recent report, Medical Imaging Markets: MRI and Ultrasound the market for MRI continues to grow despite the recession. This is due to improvements in MRI cameras and also imaging agents.

One advance which likely to further drive the use of MRI, specifically in the area of pancreobiliary imaging is Repligen's RG1068. Yesterday, the company announced Phase 3 data supporting the use of RG1068 in combination with MRI for the diagnosis of pancreatic and biliary disease.

Diagnosis of pancreatic and biliary disease can be achieved through MRI or ERCP.

ERCP (endoscopic retrograde cholangiopancreatography) is a procedure used to image the pancreas and bile duct. The procedure involves the local introduction of water soluble iodine-based contrast media directly through the biliary and pancreatic ducts under endoscopic guidance. This then allows imaging using X-ray.

ERCP is considered a good test for diagnosis of ampullary cancers, chronic pancreatitis and duct stones. The procedure also has the advantage of being able biopsy and/or treat at the same time as diagnose. Balanced against this advantage however is the risk of adverse events such as hypersensitivity. In addition the procedure is invasive requiring patient sedation and requires considerable clinical experience. Ideally, ERCP should be reserved for those at greatest need.

MRCP offers an alternative to ERCP. Use of MRCP was first reported in 1991. This procedure replaces endoscopic intervention with an MRI and so is less invasive. One disadvantage however is that image quality may not be as good as with ERCP. RG1068 offers the potential to address this situation.

RG1068 is a synthetic version of human secretin, which stimulates the secretion of pancreatic fluid into the pancreatic ducts, thereby filling the ducts with water, which improves the ability to visualize pancreatic abnormalities. The FDA has granted RG1068 Orphan Drug status and Fast Track Designation, and Repligen estimates that there are approximately 300,000 MRI procedures conducted in the U.S. and Europe each year that could directly benefit from the addition of RG1068.

The Phase 3 data evaluated the ability of RG1068 to improve: sensitivity of detection of
abnormalities without a meaningful lose of specificity; and image quality. Both measures were improved. This contrast with an earlier analysis of the data based on which the study failed to meet its end-points. This was due to "flawed analysis due to deficiencies in performance by the contract research organization overseeing the original analysis". The FDA approved the re-read.

If, based on these data, RG1068 is approved the numbers of ERCP procedures conducted are likely to fall as patients in which the procedure is not required are triaged to alternative therapeutic regimens. Although absolute numbers of ERCP procedures may fall, improvements in endoscopy technology means that success in those procedures that are conducted may increase.

According to The World Market for Gastrointestinal Endoscopy Equipment, the GI endoscopy market is expanding due to improved technologies such as robotics. This expansion covers all types of GI diseases and is primarily being driven by the increase in GI cancers. We expect that ERCP will benefit from such advances but will increasingly be used after initial MRI diagnosis.