Development of a novel manganese based contrast agent - a new paradigm within MRI

Offentlig prosjektsammendrag

GE HealthCare (GEHC) is one of the global leaders within medical imaging and has commitment to further innovation in this field. Magnetic Resonance Imaging (MRI) is a fast-growing imaging modality and GEHC is building a portfolio to address radiologists’ needs for their patients. Typically, MRI contrast agents (CAs) are based on the rare earth metal gadolinium (Gd). A few years back GEHC AS (Norway) started investigating the use of manganese (Mn), an element naturally occurring in, and efficiently eliminated from, the human body as the MRI active moiety in a novel class of CAs, broadening GE HealthCare’s portfolio of MRI contrast agents and providing a potential alternative in light of perceived concerns relating to Gd retention. The discovery project identified a lead product candidate that fulfilled the criteria for entering into a full development program. In March 2023 GEHC announced the successful completion of Phase 1 clinical trial, based at the clinical research unit at the Oslo University Hospital, investigating the safety profile and how the agent is eliminated from the body in healthy volunteers. The project goal is to continue development of the project towards market launch. The Active Pharmaceutical Ingredient is a new molecule, and the multiple step chemical process will have to be further developed to arrive at a technically viable commercial manufacture, that is also environmentally sustainable. Pharmaceutical development on Drug Product formulation and manufacture will be carried out to arrive at an injectable product that is safe and meets the quality requirements. A crucial part is development of the corresponding analytical methods and documentation. Further clinical trials will include patients with with various pathology, to assess the MRI contrast enhancement provided by the product, including comparison with standard care Gd agents, as well as continued monitoring of safety and how the product is distributed in and excreted from the body