Update on company development, project progress and timelines
IC Targets AS strengthens its team
By recruiting three highly skilled experts, Jonny Østensen (Project Leader Manganese-enhanced MRI in Heart Failure), Miriam Balstad, (Senior Regulatory Affairs Manager) and Christina Abrahamsberg (Chief Scientific Officer) the company is well prepared to drive its main projects. The three experts bring extensive expertise and a strong background in research, clinical development, manufacturing and life cycle management of contrast agents to the company.
“The new team members will be vital to IC Targets to reach the next milestones and position the company for future growth”, said Håkon Sæterøy, Chairman of IC Targets AS.
Update on company projects
Cardiac project – preclinical study initiated
For the cardiac indication the development project “Mangafodipir-enhanced MRI for myocardial characterization in Heart Failure” is 70 % funded by the Research Council of Norway (RCN). The main objective of the cardiac project is to validate a MRI procedure which will enable characterization of calcium handling at a cellular level. This is expected to represent a major improvement over conventional contrast enhanced imaging.
As one milestone in this RCN-funded project, the preclinical study was successfully initiated during H1/2022. The study is done in collaboration with the Intervention Center at Oslo University Hospital (OUH) and will be finalized by the end of 2022. Results of this preclinical study will make a basis for the initiation of the cardiac clinical development program.
The clinical trial will focus on Heart Failure with preserved Ejection Fraction (HFpEF) patients. The complex pathophysiology of HFpEF makes it a diagnostic and therapeutic challenge. Only recently, specific drug treatment options for this patient group have become available. Novartis’ Entresto® was FDA approved as the first drug for treatment of HFpEF in February 2021, followed by Jardiance® (Boehringer Ingelheim) in February 2022. Additional drug approvals can be expected, as Farxiga® (AstraZeneca) met the primary endpoint in a Phase III trial showing improved symptom burden and health-related quality of life in patients with mildly reduced or preserved ejection fraction. These FDA approvals open an enormous demand for diagnostic methods translating the better understanding of the pathophysiology in subgroups of HFpEF into clinically applicable strategies.
The novel IC Targets procedure may provide a tool for improved selection of therapy and monitoring of treatment efficacy in patients with heart diseases where calcium handling is altered, such as ischemic heart disease, dilated and hypertrophic cardiomyopathies and heart failure. Our long-term goal is to get approval for mangafodipir-enhanced MRI (MEMRI) in all common heart diseases where calcium handling may be altered.
MRI of lesions of the liver and pancreas
In parallel with the cardiac innovation project, IC Targets aims to relaunch the product on a global basis for the previously marketed indications for the detection of lesions in the liver and pancreas.
Active Pharmaceutical Ingredient (API) synthesis development work and technical batch production were successfully achieved during 2022. Manufacturing of the API GMP batches is currently ongoing and will be finalized by December 2022. These API batches will be used for manufacturing of the Finished Dosage Forms (FDF) of mangafodipir trisodium injection in 2023. The chemical and pharmaceutical development work on the mangafodipir product is carried out for the benefit of both of the two company projects.
In parallel with the development work, the regulatory pre-submission activities for the original indications, including preparation of the dossier, will be carried out during 2023. The objective is to submit for a marketing authorisation in the EU in Q1/2024.
IC Targets sees a significant potential for the product in the previously marketed indications. The commercial strategy will initially focus on the European and North American markets.
Patents – PCT application for cardiac application filed
Our patent portfolio has been strengthened in June 2022 by filing a PCT application for “Mangafodipir-enhanced MRI for myocardial characterization in heart failure”. Upon grant, the new patent will further improve the value proposition of mangafodipir trisodium and extend the patent protection rights until 2041. National patent filings in strategic markets will be carried out until the end of 2023.
Key priorities going forward
Preparatory activities for the clinical Phase 2a trial of the cardiac project, including manufacturing of mangafodipir trisodium, are ongoing. The clinical trial application is planned for Q4/2023, patient recruitment will start in Q1/2024. Initiation of the clinical trial will be a major milestone within the RCN-funded cardiac project. Patients will be recruited within a period of approximately 12 months. Results of the clinical trial are anticipated for Q1/2025 and are then expected to make a basis for industrial partnering and sub-licensing agreements.
ICT is working to establish the supply chain for the product with manufacturing of the FDF as a major milestone during H1/2023. The objective is to submit a European marketing authorisation application for mangafodipir trisodium injection for the detection of focal lesions of the liver and the pancreas during Q1/2024.