RG1068: Phase III data
Top-line data from 228 evaluable patients in a U.S. and Canadian Phase III trial showed that RG1068 in combination with MRI missed the trial's predetermined criteria for success of meeting the co-primary endpoints with 2 out of 3 blinded radiologists. The co-primary endpoints were improved sensitivity of detecting pancreatic ducts' structural abnormalities compared to MRI alone with minimal loss in specificity (<7.5%).
Specifically, only 1 radiologist achieved a significant improvement in sensitivity with RG1068 (p<0.001) with a specificity loss of 4.3%. The other two radiologists did not achieve significant improvements in sensitivity but did achieve minimal loss of specificity. Pooled data from all 3 radiologists showed RG1068 significantly improved sensitivity (p=0.005) with 1% loss in specificity, although this was not a prespecified endpoint. ...