Ascelia Pharma AB (publ) reported the need for a re-evaluation of the collected images in the pivotal Phase 3 study SPARKLE with the liver imaging candidate drug Orviglance®. As per FDA guidance, a pre-defined number of patients were evaluated twice. This showed a high level of variability in the evaluation of images by some readers, which necessitates a re-evaluation of all images by a new group of independent radiology readers.

Ascelia Pharma completed the global multi-center SPARKLE study in early March 2023 with MRI data from 85 completed patients. Since then, the MRI images have been read and evaluated by three independent radiologists as required by regulatory standards. During the evaluation of headline data, the company identified a high level of inconsistency in the image scoring by some individual readers, i.e., intra-reader variability.

Intra-reader variability occurs when a reader reports different scores for the same image when seen at a different time point. This finding means that data from SPARKLE cannot be reported based on the performed reading. The patient recruitment and collection and transfer of MR images to the central database has been correctly performed and the company does not see a need for a new clinical study.

Common adverse events in the SPARKLE study were in line with previous studies with Orviglance, such as mild to moderate nausea. No drug related serious adverse reactions were reported.