Deadline: 5-Sep-24
The European Commission (EC) is offering grants to support the development of novel antivirals under the EU4 Health Programme (EU4H).
Objectives
- This action supports the policy priority to be better prepared to respond to serious cross-border health threats. It contributes to the achievement of the EU4Health Programme’s general objective of protecting people in the Union from serious cross-border threats to health and strengthening the responsiveness of health systems and coordination among the Member States to cope with serious cross-border threats to health (Article 3, point (b), of Regulation (EU) 2021/522) through the specific objectives defined in Article 4, points (b) and (c), of Regulation (EU) 2021/522.
Strand (scope)
- Crisis preparedness
Funding Information
- The estimated available call budget is EUR 149 000 000.
- Topic budget: EUR 10.000.000
- Indicative project budget: EUR 10.000.000
- Expected number of grant agreements to be signed: 1
- Duration: 24 months
Expected Impact
- HERA’s threat assessment of 2022 included a vulnerability analysis with regard to the availability or absence of medical countermeasures, in particular the availability of vaccines and treatment options. Given that the large majority of identified virus families lack effective vaccines and/or effective therapeutics at EU and global level, HERA’s longterm aim is to, inter alia, support the creation of a diverse portfolio of BSAs and BCCs that can be further developed in clinical by identifying most promising candidates and supporting their characterisation and assessment, including through clinical trials. Actions funded under this topic are therefore expected to either bring innovative, emerging, and cutting-edge elements with significant economic potential to the internal market or to reduce or prevent strategic dependencies of the Union, including by contributing to the Union technological leadership in the innovation and development of BSA and enhancing the access to these products in the EU.
Activities that can be funded
- This action aims to diversify and advance the pipeline of BSA candidates. More specifically, it will support the development and further characterisation of broadspectrum antivirals targeting identified HERA priority viral families, which largely can be divided among respiratory RNA viral families, such as Paramyxo-, Orthomyxo and Coronaviridae, as well as those targeting viral families known for causing viral haemorrhagic fever (VHF), such as Arena-, Bunya-, Flavi-, Filoviridae. The action aims to identify a potent BSA candidate, in order to advance its clinical development. A robust pipeline should contain multiple BSA candidates for each viral family that are developed in parallel. When selecting the BSA candidate, attention will be paid to the complementarity with existing Horizon Europe projects. Synergies with projects funded under the topic HORIZON-HLTH-2023-DISEASE-03-04 should be sought.
- The proposal would need to cover early safety and efficacy trials for testing new or improved anti-viral therapeutics, with a clear regulatory and clinical pathway, including first in humans.
- Innovative delivery systems and suitable safety profiles for broad use should be considered when possible as well as application of novel approaches and widely applicable workflows (e.g. artificial intelligence) for rapid and reliable identification of broad-spectrum anti-viral therapeutics.
Specific mandatory Deliverables and/or Milestones
- Applicants should provide details of the studies and tests supported (including efficacy testing in animal and/or human challenge models) as well as:
- Ethical approvals for testing and/or clinical protocols.
- When applicable, patient enrolment plan and implementation, ensuring that those trials are preferably carried out in the EU.
- Testing and trial results including those towards the establishment of maximum tolerated dose, dose ranging, adverse effects, pharmacokinetics and pharmacodynamics.
- Documentation resulting from engagement with regulatory bodies: applicants are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view.
Eligibility Criteria
- In order to be eligible, the applicants (beneficiaries and affiliated entities) must:
- be legal entities (public or private bodies)
- be established in one of the eligible countries, i.e.:
- EU Member States (including overseas countries and territories (OCTs))
- eligible non-EU countries:
- listed EEA countries and countries associated to the EU4Health Programme
For more information, visit EC.