IMI2 – Call 21: Development of therapeutics and diagnostics combatting coronavirus infections
The Innovative Medicines Initiative is a jointly funded partnership between the European Union, represented by the European Commission, and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
Proposals submitted under this topic are expected to advance our knowledge of SARS-CoV-2 specifically and the wider coronavirus family in general with the aim of contributing to an efficient patient management and/or public health preparedness and response to current and future outbreaks of coronavirus infection. Considering that this is a newly-identified virus, the scope of this topic remains broad and must address at least one of the following objectives:
- Development of antivirals as well as other types of therapeutics to address a rapid response to the current COVID-19 outbreak
- Relevant “clinical ready”-assets include approved therapies or compounds in development, which could be repurposed for use in treating patients with the coronavirus. For example, this could include (but is not limited to), angiotensin-converting-enzyme (ACE) inhibitors, protease inhibitors or immunotherapies (for example antibodies/antibody-like molecules) that could be relevant in the context of CoV. If repurposing is proposed, this should be supported by a preliminary rationale of the compound’s potential efficacy against COVID-19. Where relevant, evidence of regulatory and ethics approvals for the investigational products included in the study(ies) must be presented.
- Development of therapeutics to address the current and/or future coronavirus outbreaks
- Identification of new potential assets and approaches that could be utilised including preventive strategies and combination approaches, and that could also address potential resistance. This may also include the optimisation of promising treatments used in rapid response (e.g. reformulation).
- Development of diagnostics, ensuring rapid evaluation of candidates based on existing technologies.
- Diagnostic tests will be essential for clinical trials of new or repurposed drugs, to help stratify patients and assess treatment efficiency (surrogate endpoint such as viral clearance).
- Development of fast and reliable tools that go beyond the state of the art for detection of COVID-19 carriers and symptomatic individuals suspected of COVID-19 infection
- These are essential and of utmost importance to manage the outbreak, isolate patients at risk and treat people accordingly. It is crucial to differentiate and identify respiratory pathogens with similar clinical symptoms (e.g. flu, respiratory syncytial virus, other viruses or bacteria) and/or detect emerging pathogens such as SARSCoV-2. This can be achieved through point-of-care (POC) testing or centralised testing.
Preventive vaccines are specifically excluded from the scope of the Call.
For increased impact, proposals should build on promising avenues from previous or ongoing research, taking into account the recommendations from the WHO and ensuring complementarity and ideally synergy with the work carried out under the auspices of Coalition for Epidemic Preparedness Innovations (CEPI), Wellcome, Biomedical Advanced Research and Development Authority (BARDA), the Bill and Melinda Gates Foundation, Global Research Collaboration for Infectious Disease Preparedness (GloPID-R) and H2020 Call SC1-PHECORONAVIRUS-2020. The European Medicines Agency (EMA) has activated its plan for emerging health threats, which includes the possibility for fast-tracked Scientific Advice . Proposals covering investigation of a therapeutic should engage with the EMA to ensure adequacy from a regulatory point of view.
Each proposal must include at least one of the following key deliverables:
- antivirals as well as other types of therapeutics to be used in the current outbreak, including preventive and symptomatic treatments;
- novel therapeutics including combination treatments to ensure appropriate treatment for current and/or future outbreaks and/or to prevent resistance;
For more details, see the full call text here.