Phase 2A clinical trial in Heart Failure patients: First participants dosed with mangafodipir

IC Targets AS announced dosing of first participants with mangafodipir in a Phase 2A trial assessing myocardial calcium channel activity with mangafodipir-enhanced Magnetic Resonance Imaging (MRI).

The overall objective of this Phase 2A Proof-of-Concept trial is to assess the efficacy and safety of mangafodipir-enhanced MRI for assessing myocardial calcium channel activity in patients suffering from Heart Failure with preserved Ejection Fraction (HFpEF), caused by hypertrophic cardiomyopathy or cardiac amyloidosis.
The open-label trial will be performed in 42 healthy and HFpEF participants at Oslo University Hospital (OUS), Norway, led by Prof. Thor Edvardsen MD, PhD. It is estimated to be completed during 2025.

Mangafodipir-enhanced MRI is a breakthrough imaging process developed to redefine cardiac diagnostics and treatment monitoring by enabling unparalleled insights into myocardial function and dynamics. Our solution is particularly impactful in diagnosing and managing HFpEF, a condition that affects millions of people globally and poses significant diagnostic challenges due to its complex pathophysiology.

The currently available contrast agents in MRI primarily detect cell loss caused by replacement fibrosis, and measurements of the extracellular volume provide clues about the status of interstitial fibrosis. However, the Phase 2A trial aims to utilise mangafodipir to measure cellular function independent of the impact of fibrosis. This information could be vital for accurate diagnosis, selection and monitoring of therapy“, said Jonny Østensen, Chief Scientific Officer.

We are happy to have started enrollment in the first cardiac mangafodipir trial. The initiation of the Phase 2A trial is an important step in advancing the mangafodipir cardiac development program”, said Christina Abrahamsberg, Chief Operating Officer.

This R&D project “Manganese-enhanced MRI in Heart Failure” has received funding from the Research Council of Norway within the category “Innovation Project for the Industrial Sector” under grant agreement # 327815.