Ascelia Pharma AB announced that the Last Patient Last Visit (LPLV) has now been completed and 85 patients in total have successfully completed the pivotal phase 3 clinical study SPARKLE with the lead candidate drug Orviglance®. Next step will be the evaluation of the magnetic resonance imaging (MRI) images by independent radiologists as required by regulatory standards and in the study protocol. The headline results from the SPARKLE study are expected in mid-2023.

The global multi-center SPARKLE study aims to demonstrate that Orviglance improves the detection and visualization of focal liver lesions, including liver metastases and primary tumors, in patients with severe kidney impairment. It is the last of nine studies in the extensive clinical development program for Orviglance, which will enable Ascelia Pharma to complete a New Drug Application (NDA) submission to the FDA.