Ascelia Pharma AB (publ) announced that by January 27, 2023, 71 patients have completed the pivotal Phase 3 clinical SPARKLE study with the lead candidate drug Orviglance. On December 29, 2022, Ascelia Pharma announced that 65 patients had completed the SPARKLE study, which will include 80 patients in total. Since that announcement, 6 more patients have completed the study. The company expects to complete patient enrollment by February/March 2023 with topline results by mid-2023. The SPARKLE study is the third and last of three clinical studies that form the Phase 3 program
for Orviglance, the company's orphan liver imaging agent. Orviglance (manganese chloride tetrahydrate) is a novel oral contrast agent for MR-imaging
developed to improve the detection and visualization of focal liver lesions (including liver metastases and primary tumors) in patients with reduced kidney function. These patients are at risk of serious side effects from the currently available class of gadolinium-based contrast agents. Orviglance, which has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA), is currently in Phase 3 development, including the global multi-center SPARKLE study. Oncoral is a novel irinotecan chemotherapy tablet developed initially for the treatment of gastric cancer. Irinotecan chemotherapy has an established potent anti-tumor effect. Oncoral is a daily tablet with the potential to offer better patient outcomes with improved safety following the daily dosing at home compared to intravenous high-dose infusions at the hospital. Following successful Phase 1 results, Oncoral is now prepared for Phase 2 clinical development.