UPDATE 1-Repligen pancreatic imaging agent does not meet goal
* Trial did not achieve pre-specified statistical outcome
* Company to discuss development plans for RG1068 with FDA
Dec 9 (Reuters) - Repligen Corp (RGEN.O) said a late-stage trial of its pancreatic imaging agent RG1068 to improve magnetic resonance imaging (MRI) of the pancreas in patients with a history of pancreatitis did not meet its main goal.
Although the study did not achieve the pre-specified statistical outcome for the primary goal, the company said, it provides further evidence of the benefits of RG1068 in MRI imaging of the pancreas.
The study's co-primary goals were improvements in sensitivity of detection of structural abnormalities of the pancreatic ducts using RG1068 in combination with MRI compared to MRI alone with minimal loss in specificity.
Repligen said it would decide on further development plans for RG1068 after it discussed the results with the U.S. Food and Drug Administration next quarter.
RG1068, which has orphan drug status and fast track designation from the FDA, is a synthetic version of human secretin, a natural gastrointestinal hormone involved in the process of digestion.
Shares of Repligen closed at $4.67 Tuesday on Nasdaq. (Reporting by Jennifer Robin Raj in Bangalore; Editing by Mike Miller)
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