Ascelia Pharma has enrolled its first patient in a phase III clinical study to evaluate an oral MR imaging contrast agent called Mangoral for liver disease.
The Safety and Diagnostic Efficacy of Mangoral in Patients with Focal Liver Lesions and Reduced Kidney Function (SPARKLE) trial is a global multicenter study designed to determine the efficacy and safety of Mangoral to detect and visualize lesions in patients with known or suspected liver cancer and who also have severely impaired renal function. In particular, Mangoral would be used for patients who cannot tolerate gadolinium-based contrast agents.
The U.S. Food and Drug Administration has given Mangoral an orphan drug designation, which allows for its use to treat a rare disease or condition. Primary efficacy, in terms of lesion visualization compared with unenhanced MRI, will be evaluated by three independent blinded readers. MRI scans will be performed before and shortly after oral Mangoral administration, with basic safety parameters evaluated for five days following administration.
Ascelia Pharma plans to enroll up to 200 patients for the trial and expects to have a full study report in the first half of 2021.