Development of innovative antimicrobials against pathogens resistant to antimicrobials

Expected Outcome: This topic aims at supporting activities that are enabling or contributing to one or several expected impacts of destination “Tackling diseases and reducing disease burden”. To that end, proposals under this topic should aim to deliver results that are directed at, tailored towards and contributing to all the following expected outcomes: The scientific and clinical communities have a better understanding of and access to new and innovative products for the treatment of antimicrobial resistant bacteria and fungi, as well as for further clinical investigation. Candidate therapies are available to treat patients for antimicrobial resistant bacteria and fungi, increasing therapeutic options for clinical deployment in the fight against Antimicrobial Resistance (AMR). Scope: The rapid rise of AMR presents a formidable threat to public health, challenging our ability to treat infections that were once easily managed with standard antimicrobials. As pathogens continually adapt and develop resistance to existing drugs, the efficacy of these treatments diminishes, leading to more severe and prolonged illnesses, increased healthcare costs and productivity losses, and higher mortality rates. This escalating crisis underscores an urgent need for viable therapeutic alternatives required to reduce the burden of diseases caused by antibiotic resistance. Innovative solutions are crucial to maintaining effective disease management and safeguarding public health. Proposals should pursue the development of innovative and effective antibacterial and antifungal agents, including antibody-based therapies, which meet at least one of the four World Health Organization (WHO) innovation criteria [1] , namely: i) new chemical class, ii) new target, iii) new mode of action and iv) no evidence of cross-resistance. This topic contributes to strengthening the Research and Innovation ecosystem within the EU and supports the implementation of the European Medical Countermeasures Strategy [2] and the forthcoming Critical Medicines Act [3] . Proposals under this topic should not pursue the development of phage-therapies. Applicants should explicitly state in their proposal which of the following pathogens is targeted and the proposed work should address only this specific pathogen. The proposed work should pursue the development of existing therapeutic candidates targeting exclusively one of the following pathogens: Carbapenem resistant Acinetobacter baumanii (CRAB) Carbapenem-resistant Enterobacterales (CRE) and third-generation cephalosporin-resistant Enterobacterales (C3GRE) Carbapenem resistant Pseudomonas aeruginosa Methicillin-Resistant Staphylococcus aureus (MRSA) (Drug)-resistant Aspergillus fumigatus (Drug)-resistant Candida spp Identifying a specific pathogen does not preclude the exploration of these candidates' effects on other bacteria or fungi. Proposals should thus aim to accelerate testing of novel candidates in human trials, diversify and accelerate the global prophylactic and therapeutic research and development portfolio for AMR bacterial and fungal infections, and to strengthen the leading role of the EU in prophylactic and therapeutic research and development. Proposals should address all the following areas: If necessary, finalisation of in-vivo tests in at least one animal model or, if available in humanised immune system animal models, to demonstrate the protective function of the therapeutics deemed sufficient for moving to first clinical trials. If requested by regulators as pre-requisite for clinical studies, in-vivo tests in a non-human primate model. Production of batches of the most promising antimicrobials candidates according to the Good Manufacturing Practices (GMP) [4] . In human clinical safety and efficacy studies, demonstrating a clear regulatory pathway for market authorisation. Attention should be paid to critical biological and social factors such as sex, age, ethnicity, disability and vulnerability. Participation of third countries where AMR bacteria and fungi in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged. The participation of start-ups, micro, small and medium-sized enterprises (SMEs) [5] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation. All projects funded under this topic are expected to engage with regulatory bodies in a timely manner to ensure adequacy of the actions from a regulatory point of view. Proposals should advance research by leveraging already existing and emerging state-of-the-art research initiatives such as the co-funded European Partnership on One Health Anti-Microbial Resistance (EUP OHAMR) [6] . Applicants should provide details of their clinical studies [7] in the dedicated annex using the template provided in the submission system. As proposals under this topic are expected to include clinical studies, the use of the template is strongly encouraged. [1] https://www.who.int/publications/i/item/9789240093461 [2] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en [3] https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en [4] https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en [5] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361 [6] https://cordis.europa.eu/project/id/101217154 , https://ohamr.eu [7] Please note that the definition of clinical studies (see introduction to this Work Programme part) is broad and it is recommended that you review it thoroughly before submitting your application.

Topics under this destination are directed towards the Key Strategic Orientation 3 “ A more resilient, competitive, inclusive, and democratic Europe ” of Horizon Europe’s strategic plan 2025-2027 [1] . Research and Innovation supported under this destination should contribute to the following expected impact, set out in the strategic plan impact summary for the Health Cluster: “ healthcare providers improve their ability to tackle and manage diseases (infectious diseases, including poverty-related and neglected diseases, non-communicable and rare diseases) thereby reducing the disease burden on patients and enabling healthcare systems to perform more effectively. It can be achieved through better understanding, prevention, diagnostics, treatment, management, and cure of diseases and their co- and multi-morbidities, more effective and innovative health technologies and medical countermeasures, better ability and preparedness to manage pandemic and/or epidemic outbreaks, and improved patient safety ” . Communicable and non-communicable diseases pose a significant health, societal, and economic threat worldwide, causing premature deaths and disabilities. Despite being largely preventable, only 6% of healthcare budgets are spent on prevention [2] . To address this, there is an urgent need to develop new public health interventions, preventive, diagnostic, and therapeutic approaches, alternatives to antimicrobials, as well as to improve existing preparedness and response strategies to create tangible impacts, considering sex/gender-related issues. To address these challenges, Research and Innovation will require international cooperation to leverage global expertise, access world-class research infrastructures and invest in priority needs, aligning with other funders of international cooperation in health Research and Innovation. The continuation of international partnerships and cooperation with international organisations is particularly needed to combat infectious diseases and respond to public health needs, including rare diseases and the global burden of non-communicable diseases. In this Work Programme part, Destination “ Tackling diseases and reducing disease burden ” will focus on major societal challenges linked to the Commission's Political Guidelines for 2024-2029 [3] , such as the fight against non-communicable and communicable diseases, mental health, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment, of Antimicrobial-Resistant (AMR) infections, coherent also with wider EU initiatives such as the European Medical Countermeasures Strategy [4] and the forthcoming Critical Medicines Act [5] . In particular, the topics under this destination will support activities aiming at: i) new treatment and disease management options to reduce burden on non-communicable diseases and long-term conditions after post-bacterial and post-viral infections; ii) improve and protect mental health of children and young adults; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) innovative therapies for AMR critical pathogens; and v) support to second phases of the co-funded European Partnership on Rare Diseases [6] and the co-funded European Partnership for Pandemic Preparedness [7] . To increase the impact of EU investments under Horizon Europe, the Commission encourages cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities, such as participating in joint workshops, exchanging knowledge, developing and adopting best practices, or undertaking joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic, as well as between projects funded under different topics, Clusters, or Pillars of Horizon Europe. For example, synergies could be sought with projects funded under the European health research infrastructures (Pillar I of Horizon Europe), the EIC [8] strategic challenges on health (Pillar III of Horizon Europe), or with projects on themes that cut across the Clusters under Pillar II of Horizon Europe, such as health security/emergencies under Cluster “Civil Security for Society”, Artificial Intelligence (AI)-based tools and technologies under Cluster “Digital, Industry and Space”, or antimicrobial resistance under Cluster “Food, Bioeconomy, Natural Resources, Agriculture and Environment”. The Commission aims to foster synergies between Horizon Europe and other EU programmes. To this end, applicants are encouraged to explore the funding opportunities available through the EU4Health Programme (2021-2027) [9] , the EU's public health programme, as a means of capitalising on potential collaborations and maximising impact. Expected impacts : Proposals for topics under this destination should set out a credible pathway to contributing to tackling diseases and reducing disease burden, and more specifically to several of the following impacts: Disease burden in the EU and worldwide is reduced through effective disease management, including through the development and integration of innovative preventive, diagnostic and therapeutic approaches, digital and other people-centred solutions for healthcare. Premature mortality from non-communicable diseases is reduced by one third (by 2030), mental health and wellbeing are promoted, and the targets of the World Health Organization (WHO) Global Action Plan for the Prevention and Control of non-communicable diseases [10] , [11] are attained, with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs) [12] . Healthcare systems benefit from strengthened Research and Innovation expertise, human capacities and know-how for combatting communicable and non-communicable diseases, including through international cooperation. Citizens benefit from reduced (cross-border) health threat of epidemics and AMR pathogens, in the EU and worldwide [13] , [14] , [15] . Patients and citizens are knowledgeable of disease threats, involved and empowered to make and shape decisions for their health, and better adhere to knowledge-based disease management strategies and policies (especially for controlling outbreaks and emergencies). Legal entities established in China are not eligible to participate in both Research and Innovation Actions (RIAs) and Innovation Actions (IAs) falling under this destination. For additional information please see “Restrictions on the participation of legal entities established in China” found in the Annex B of the General Annexes of this Work Programme. The protection of European communication networks has been identified as an important security interest of the Union and its Member States. Entities that are assessed as high-risk suppliers [16] of mobile network communication equipment (and any entities they own or control) are not eligible to participate as beneficiaries, affiliated entities and associated partners to topics identified as “subject to restrictions for the protection of European communication networks”. Please refer to the Annex B of the General Annexes of this Work Programme for further details. [1] https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe/strategic-plan_en [2] Preventive healthcare expenditure as a share of the current expenditure on healthcare: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=File:Preventive_healthcare_expenditure_as_a_share_of_current_expenditure_on_healthcare,_2021_(%25)_HCE2024.png [3] https://commission.europa.eu/about/commission-2024-2029_en [4] https://health.ec.europa.eu/health-emergency-preparedness-and-response-hera/preparedness/medical-countermeasures-strategy_en [5] https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en [6] https://cordis.europa.eu/project/id/101156595 , https://erdera.org [7] https://cordis.europa.eu/project/id/101226682 , https://beready4pandemics.eu [8] https://eic.ec.europa.eu [9] https://commission.europa.eu/funding-tenders/find-funding/eu-funding-programmes/eu4health_en [10] https://www.who.int/publications/i/item/9789241506236 [11] https://www.who.int/publications/m/item/implementation-roadmap-2023-2030-for-the-who-global-action-plan-for-the-prevention-and-control-of-ncds-2023-2030 [12] Disability-adjusted life year (DALY) is a quantitative indicator of overall disease burden, expressed as the number of years lost due to ill-health, disability or early death. [13] WHO global action plan on antimicrobial resistance, 2015 [14] EU One Health Action Plan against AMR, 2017 [15] https://www.ema.europa.eu/en/news/one-health-joint-framework-action-published-five-eu-agencies [16] Entities assessed as “high-risk suppliers”, are currently set out in the second report on Member States’ progress in implementing the EU toolbox on 5G cybersecurity of 2023 (NIS Cooperation Group, Second report on Member States’ progress in implementing the EU Toolbox on 5G Cybersecurity, June 2023) and the related Communication on the implementation of the 5G cybersecurity toolbox of 2023 (Communication from the Commission: Implementation of the 5G cybersecurity Toolbox, Brussels, 15.6.2023 C(2023) 4049 final).

Online Manual is your guide on the procedures from proposal submission to managing your grant. Horizon Europe Programme Guide contains the detailed guidance to the structure, budget and political priorities of Horizon Europe. Funding & Tenders Portal FAQ – find the answers to most frequently asked questions on submission of proposals, evaluation and grant management. Research Enquiry Service – ask questions about any aspect of European research in general and the EU Research Framework Programmes in particular. National Contact Points (NCPs) – get guidance, practical information and assistance on participation in Horizon Europe. There are also NCPs in many non-EU and non-associated countries (‘third-countries’). Enterprise Europe Network – contact your EEN national contact for advice to businesses with special focus on SMEs. The support includes guidance on the EU research funding. IT Helpdesk – contact the Funding & Tenders Portal IT helpdesk for questions such as forgotten passwords, access rights and roles, technical aspects of submission of proposals, etc. European IPR Helpdesk assists you on intellectual property issues. CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk – the European Standards Organisations advise you how to tackle standardisation in your project proposal. The European Charter for Researchers and the Code of Conduct for their recruitment – consult the general principles and requirements specifying the roles, responsibilities and entitlements of researchers, employers and funders of researchers. Partner Search help you find a partner organisation for your proposal.

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