Ascelia Pharma has announced that the first patient has been enrolled in the company’s global Phase III clinical study SPARKLE with Mangoral in patients with severely reduced renal function and with known or suspected liver lesions.
“It is an important event for patients seeking a safe agent to detect liver lesions that this pivotal Phase III study is now enrolling study subjects. We see the interest from premier hospitals and expert doctors to participate as a testimony to the unique potential offered by Mangoral and the large unmet medical need for these patients. The addressable market for Mangoral is $350-500 million annually, and Mangoral, if approved, will be the only product on the market for this patient segment. We are excited to now be one step closer to launch Mangoral to the market, which we expect to happen in 2022,” said Magnus Corfitzen, CEO of Ascelia Pharma.
The first oral imaging drug being developed for liver MRI
Mangoral is the first oral imaging drug being developed for liver MRI, states the company in its press release. In addition, Mangoral is covered by an Orphan Drug Designation in the US, targeting the unmet need in patients who cannot tolerate currently marketed contrast agents due to impaired kidney function.
”Liver metastases and primary liver malignancies are very serious manifestations of cancer. It is therefore essential to early and accurately detect and diagnose liver lesions to be able to offer patients the best treatment options. This can have significant impact on patient survival,” said Carl Bjartmar, Chief Medical Officer of Ascelia Pharma. “Mangoral has the potential to fill this specific unmet medical need for patients that today are restricted from using currently available contrast agents for liver imaging. The management of these patients today is an MRI of the liver without any contrast agent. Mangoral offers the potential for improved liver images in this patient group and may consequently enable better treatment options which ultimately can improve their chances of survival.”
Full study report in first half of 2021
SPARKLE is a global multicenter, registration-enabling study of Mangoral in up to 200 patients with severely reduced renal function and with known or suspected liver lesions. Ascelia Pharma expects full study report in first half of 2021.
The study aims to demonstrate the efficacy and safety of Mangoral in terms of improved lesion visualization as compared to unenhanced MRI, with each patient being their own control subject. Primary efficacy, in terms of lesion visualization compared to unenhanced MRI, will be evaluated by three independent blinded readers.
MRI will be performed before and shortly after oral Mangoral administration, and basic safety parameters will be evaluated for five days following administration.