Ascelia Pharma

The scientific review article, titled Oral manganese chloride tetrahydrate, a novel magnetic resonance liver imaging agent for patients with renal impairment: efficacy, safety and clinical implication, reviews and discusses liver imaging in patients with severely impaired kidney function as well as the development of Orviglance and its potential role in clinical practice. The review article will be published in Investigative Radiology in a special issue “A new era in MR contrast media”, which will be available online in the first quarter of 2024.

“It’s a pleasure to have this publication accepted in one of the leading journals in radiology, which shows that the scientific community sees a need for novel contrast agents without gadolinium. This strengthens our confidence in the unmet need for patients and clinicians as we approach headline data from our Phase 3 study and progress Orviglance towards regulatory approval.” said Andreas Norlin, CSO of Ascelia Pharma.

Ascelia Pharma is thankful to the authors including Torkel B Brismar, MD PhD, Professor (Karolinska Institutet, Stockholm), Dominik Geisel, MD, Professor (Charité Universitätsmedizin Berlin), Nikolaos Kartalis PhD, Associate Professor (Karolinska University, Stockholm), and Beatrice L. Madrazo (University of Miami/Miller School of Medicine, Miami, Florida).

Orviglance has been granted an Orphan Drug Designation by the US Food and Drug Administration (FDA) for liver imaging in patients with severely impaired kidney function. With Orviglance, these patients can gain access to effective liver imaging without gadolinium-related safety risks. The unmet need for these patients represents an addressable market potential of USD 800 million globally; almost half of which is in the US.

Headline results from the Phase 3 clinical study, SPARKLE, with Orviglance are expected by May 2024.