Ascelia Pharma said it reached a milestone with enrollment now complete in its phase III study for Orviglance, a new MRI contrast agent for patients with kidney impairment.
The SPARKLE study reached its enrollment target of 80 patients, with topline results from the study expected in mid-2023, the company said. Standard MRI contrast agents contain gadolinium, a heavy metal that may increase the risk of serious and potentially fatal reactions in patients with impaired kidney function. Orviglance is the first manganese-based MRI contrast agent in development for use in these patients, Ascelia said.
The SPARKLE study is the last of nine studies in the clinical development program for Orviglance and is expected to enable Ascelia to complete a New Drug Application submission to the U.S. Food and Drug Administration, company officials said.
