Pandemic preparedness and response: Broad spectrum anti-viral therapeutics for infectious diseases with epidemic potential

Topic description

ExpectedOutcome:

This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination 3 “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim for delivering results that are directed, tailored towards and contributing to all of the following expected outcomes:

• The scientific and clinical communities have an increased knowledge on viruses with epidemic potential and in particular a better understanding of different potential mechanisms of action for the development of broad-spectrum anti-viral therapeutics for these viruses.
• The scientific and clinical communities have access to novel approaches for the development of anti-viral therapies for emerging and re-emerging infections in the context of epidemic and pandemic preparedness.
• The scientific and clinical communities have access to experimental broad-spectrum anti-viral candidates against emerging or re-emerging viral infections for further clinical investigation.
• A diverse and robust pipeline of broad-spectrum anti-viral drug candidates is available for emerging and re-emerging viral infections, increasing therapeutic options for clinical deployment in case of an epidemic or pandemic.

As shown by the COVID-19 pandemic, infectious diseases remain a major threat to health and health security in the EU and globally. Viral disease emergence is expected to accelerate due to among other, climate change, and thus a proactive approach to the development of anti-viral therapeutics in preparedness for future infectious disease outbreaks is needed. The availability of broad-spectrum anti-viral therapies would provide a critical preparedness measure against future health threats, due to infectious disease epidemics or pandemics.

Proposals should develop and advance broad-spectrum anti-viral compounds and develop novel approaches to the development of such compounds, which target viruses with high epidemic or pandemic potential for the EU, such as those included in the list of priority diseases of the World Health Organization (WHO)^[1], with particular attention to those meeting the criteria identified by the Health Emergency Preparedness and Response Authority (HERA)^[2].

Proposals should cover viruses for which there are no currently available effective therapeutics or for which the therapeutics available are sub-optimal, and are expected to incorporate state-of-the-art screening technology and innovative approaches to identify new targets for antiviral compound development. Emphasis should be put on the research and development of broad-spectrum antivirals, which may include repurposing of previously approved or in-pipeline drugs. Proposals could also include elucidation of mode-of-action for candidate anti-viral therapeutics.

Proposals should aim to diversify and accelerate the global therapeutic research and development pipeline for emerging and re-emerging viral infections, and to strengthen the current leading role of the EU in therapeutic research and development.

Proposals should address all of the following areas:

• Preclinical work and proof-of-concept/first-in-human studies and early safety and efficacy trials for testing new or improved anti-viral therapeutics, with a clear regulatory and clinical pathway. Phase IIb/III phase trials will not be supported.
• Innovative delivery systems and suitable safety profiles for broad use should be considered when possible. Attention should be paid to critical social factors such as sex, gender, age, socio-economic factors, ethnicity/migration, and disability.
• Application of novel approaches and widely applicable workflows (e.g. artificial intelligence) for rapid and reliable identification of broad-spectrum anti-viral therapeutics.

Applicants are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view.

Applicants envisaging to include clinical studies should provide details of their clinical studies in the dedicated annex using the template provided in the submission system. See definition of clinical studies in the introduction to this work programme part.

[1] https://www.who.int/activities/prioritizing-diseases-for-research-and-development-in-emergency-contexts

[2]https://health.ec.europa.eu/system/files/2022-07/hera_factsheet_health-threat_mcm.pdf