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.

Results from a preclinical animal study, using manganese-enhanced MRI (MEMRI) to assess the rate of manganese uptake in cardiomyocytes in vivo, are presented at the bi-annual Contrast Media Research (CMR) Symposium in Oslo, Norway.

The study evaluated a new, clinically improved MRI protocol and kinetic model for manganese-enhanced MRI (MEMRI) to assess the rate of manganese uptake in cardiomyocytes in vivo. The study results are presented by Jonny Østensen, IC Targets Project Leader, Cardiac.
Calcium cycling is an essential mediator of cardiac contractile function, and remodeling calcium handling is thought to be one of the major factors contributing to the dysfunction observed in heart failure.
Mangafodipir is an intracellular contrast agent in cardiac magnetic resonance imaging that provides information about the calcium channel activity of viable cardiac cells.
“Mangafodipir-enhanced MRI has potential as a noninvasive method to measure calcium channel activity and to detect T-tubule remodeling in heart failure, ischemic heart disease and cardiomyopathies. The procedure developed by IC Targets is relevant for the examination of patients with heart disease”, said Jonny Østensen.
Recently, IC Targets received approval in Norway to initiate its Phase 2A clinical trial with mangafodipir in patients with heart failure. “We are very excited to start enrollment of the first participants in our Proof-of-Concept (PoC) trial soon”, commented Christina Abrahamsberg, Chief Scientific Officer. “Our long-term goal is to get approval for mangafodipir-enhanced MRI (MEMRI) in all common heart diseases where calcium handling may be altered.”

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.