Repligen Corporation announced that the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have approved the company’s proposal to re-analyze the images from phase-3 study to establish the utility of RG1068, synthetic human secretin, in improving magnetic resonance imaging (MRI) of the pancreas (phase-3 re-read). The US 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 goal of the phase-3 study is 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.

“We are very pleased with the response of the US FDA and EMA to our re-read proposal,” stated Walter C Herlihy, president and chief executive officer of Repligen. “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.”

Based on our discussions, we do not anticipate any changes in the primary endpoints or significant modifications to the statistical analysis plan for the study. The EMA has requested that we add 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. ERCP is associated with significant morbidity which has generated interest in the development of safer non-invasive tests to diagnose gastrointestinal disorders. It is believed that there is sufficient evidence to document that the use of RG1068 in combination with a noninvasive procedure such as MRI leads to the avoidance of unnecessary ERCP procedures.

The US 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.

Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for neurological disorders.