Repligen Corp. reported that its imaging agent RG1068, a synthetic human secretin, showed statistically significant improvements in detecting pancreatic disease via magnetic resonance imaging, and the Waltham, Mass.-based firm plans to meet with the FDA to discuss a new drug application filing.

The positive data brought some good news for Repligen, which was hit hard earlier this month after RG2417, its oral formulation of uridine, disappointed in a Phase IIb bipolar depression trial.

But the impact of the pancreatic imaging agent is expected to be limited, and Repligen's shares (NASDAQ:RGEN) lost only 1 cent to close Monday at $3.64.

According to the company, there are about 300,000 MRI procedures conducted annually in the U.S. and Europe that could benefit from the addition of RG1068. The product, which has both orphan and fast-track status in the U.S., is designed to work by stimulating the secretion of pancreatic fluid into the pancreatic ducts, improving the ability to visualize pancreatic abnormalities that might be linked to diseases such as pancreatitis.

The 258-patient Phase III study compared RG1068 in combination with MRI vs. MRI alone and was designed to determine improvements in sensitivity of detection of structural abnormalities of the pancreatic ducts as co-primary endpoints. The original analysis of the study, completed last year, was determined to be flawed by regulators, so Repligen conducted a re-read of the data, bringing on board a new contract research organization and three new radiologists.

Data showed that all three radiologists achieved a clinically and statistically significant improvement in sensitivity, all with a "p" value of less than 0.0001, with minimal loss of specificity – less than 7.5 percent specificity was required. Images from RG1068 scans also showed highly significant improvements on image quality and diagnostic confidence when compared to MRI alone. The study used endoscopy as a diagnostic reference.

Beyond RG1068, Repligen is working on a pipeline of therapeutics, though the most advanced, RG2417, failed to mirror earlier data in bipolar depression. A subset of study participants enrolled through academic centers did show meaningful improvement. Further analysis is ongoing to determine a path forward for that drug. (See BioWorld Today, March 8, 2011.)

Earlier in development, the firm has RG3039, an inhibitor of an RNA processing enzyme that recently won a $1.4 million research grant from the Muscular Dystrophy Association, and RG2833, an HDAC-3 inhibitor for neurodegenerative diseases such as Friedreich's ataxia.

Repligen, which also brings in revenue through its bioprocessing division, reported net income of $376,000, or 1 cent per share, and had about $60 million in cash as of Dec. 31.