Repligen said that the FDA and EMA have agreed to the Phase 3 re-read based on the numerous deficiencies with the analysis of the radiographic images by the contract research organization hired to oversee analysis of the Phase 3 data. A successful re-read of the Phase 3 data may support registration of RG1068 for MRI imaging of the pancreas.

The Phase 3 study is designed to evaluate the sensitivity and specificity of RG1068 in combination with MRI to improve the detection of structural abnormalities of the pancreatic ducts relative to MRI alone. Detailed visual assessment of the pancreatic ducts is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis.

The EMA has requested that Repligen had added an additional secondary endpoint to document that RG1068 in combination with MRI imaging reduces the use of endoscopic retrograde cholangiopancreatography (ERCP). ERCP is an invasive procedure used to diagnose and treat diseases of the pancreas and gallbladder.

In December, Repligen has reported the top-line results from Phase 3, multi-center, baseline-controlled, single dose study in which 258 patients with a history of pancreatitis received an MRI of the pancreas with and without RG1068, and independently an ERCP. The MRI images were randomized and independently reviewed by three radiologists for evaluation of pancreatic duct abnormalities, image quality, number of duct segments visualized and confidence in diagnosis.

The FDA has granted RG1068 orphan drug status and fast track designation, a process designed to facilitate the development and expedite the review of drugs that treat serious diseases and fill an unmet medical need based on the need for safer non-invasive tests to diagnose pancreatic disorders. There are more than 300,000 MRI procedures conducted in the US and Europe each year that could directly benefit from the addition of RG1068.

Walter Herlihy, president and chief executive officer of Repligen, said: “We are very pleased with the response of the FDA and EMA to our re-read proposal. Based on the positive feedback we received from both regulatory agencies, we believe that a successful re-read may provide the basis for registration, and we have no plans to initiate additional clinical studies of RG1068 in this indication. Pending finalization of the protocol, we anticipate completing the Phase 3 re-read by the end of the year.”