Development of innovative antimicrobials against pathogens resistant to antimicrobials
Overview
The call opens on February 10, 2027, and the application deadline is April 13, 2027. This is a single-stage application process, requiring the submission of complete proposals electronically. Successful projects should focus on advanced development of therapeutic candidates that have demonstrated preliminary efficacy and are ready for clinical evaluation, addressing six priority pathogens that pose significant global health risks. Proposals must include thorough plans for in-vivo testing, Good Manufacturing Practice (GMP) compliant production of batch samples, and comprehensive human clinical safety and efficacy studies.
The opportunity emphasizes international collaboration by requiring consortia of at least three independent legal entities from different countries, reinforcing the goal of comprehensive expertise in antimicrobial development. Furthermore, engagement with regulatory bodies is critical throughout the project to ensure compliance and facilitate market access. The call highlights the urgency of innovative therapies in combating AMR, directing efforts towards practical solutions in the face of rising resistant infections.
In summary, this funding initiative represents a significant investment in research and innovation aimed at strengthening Europe’s capabilities to develop new drugs against resistant pathogens and aligns with broader European health strategies and global health priorities on AMR.
Detail
The expected outcome of this topic is to enhance the scientific and clinical communities' understanding and access to innovative products for treating antimicrobial-resistant bacteria and fungi, and to provide candidate therapies for clinical deployment against Antimicrobial Resistance (AMR).
The scope of the call addresses the urgent need for alternatives to standard antimicrobials due to the rapid rise of AMR, which leads to more severe illnesses, increased healthcare costs, and higher mortality rates. Proposals should focus on developing innovative antibacterial and antifungal agents, including antibody-based therapies, that meet at least one of the World Health Organization (WHO) innovation criteria: i) new chemical class, ii) new target, iii) new mode of action, and iv) no evidence of cross-resistance. The initiative aims to strengthen the EU's Research and Innovation ecosystem, supporting the European Medical Countermeasures Strategy and the forthcoming Critical Medicines Act. Phage-therapies are excluded.
Applicants must specify which of the following pathogens is targeted:
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
While identifying a specific pathogen, exploration of the candidates' effects on other bacteria or fungi is not precluded. The goal is to accelerate the testing of novel candidates in human trials, diversify the global research and development portfolio for AMR infections, and strengthen the EU's leading role in this field.
Proposals should address the following areas:
Finalization of in-vivo tests in at least one animal model, or humanized immune system animal models, to demonstrate the protective function of the therapeutics.
In-vivo tests in a non-human primate model, if requested by regulators.
Production of batches of promising antimicrobial candidates according to Good Manufacturing Practices (GMP).
Human clinical safety and efficacy studies, demonstrating a clear regulatory pathway for market authorization, with attention to biological and social factors such as sex, age, ethnicity, disability, and vulnerability.
Participation of third countries where AMR bacteria and fungi are endemic or where outbreaks are ongoing is encouraged. The participation of start-ups, micro, small, and medium-sized enterprises (SMEs) is also encouraged. All funded projects are expected to engage with regulatory bodies. Proposals should advance research by leveraging existing initiatives such as the European Partnership on One Health Anti-Microbial Resistance (EUP OHAMR). Applicants should provide details of their clinical studies in the dedicated annex using the template in the submission system.
The general conditions include:
Admissibility conditions described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.
Proposal page limits and layout described in Part B of the Application Form.
Eligible countries described in Annex B of the Work Programme General Annexes.
Specific provisions for funding participants from non-EU/non-Associated Countries.
Eligibility of legal entities established in the United States of America to receive Union funding.
Requirement to use Copernicus and/or Galileo/EGNOS if projects use satellite-based earth observation, positioning, navigation, and/or related timing data and services.
Financial and operational capacity and exclusion criteria described in Annex C of the Work Programme General Annexes.
Award criteria, scoring, and thresholds described in Annex D of the Work Programme General Annexes.
Submission and evaluation processes described in Annex F of the Work Programme General Annexes and the Online Manual.
Indicative timeline for evaluation and grant agreement described in Annex F of the Work Programme General Annexes.
The granting authority may object to a transfer of ownership or exclusive licensing of results up to 4 years after the action's end.
Legal and financial set-up of the grants described in Annex G of the Work Programme General Annexes.
Specific conditions described in the specific topic of the Work Programme.
Application and evaluation forms and additional documents include:
Standard application form (HE RIA, IA) available in the Submission System.
Standard evaluation form (HE RIA, IA).
HE Programme Guide.
Model Grant Agreement (MGA).
Call-specific instructions and information on clinical studies.
Additional documents such as the HE Main Work Programme 2026-2027, HE Framework Programme 2021/695, EU Financial Regulation 2024/2509, and guidelines for legal entity validation and financial capacity assessment.
The budget overview lists several topics, including:
HORIZON HLTH 2027 01 CARE 02 with a budget of EUR 38,000,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 8,000,000 to EUR 10,000,000 and an indicative number of 4 grants.
HORIZON HLTH 2027 01 DISEASE 05 with a budget of EUR 44,200,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 9,000,000 to EUR 11,000,000 and an indicative number of 5 grants.
HORIZON HLTH 2027 01 DISEASE 06 with a budget of EUR 37,300,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 9,000,000 to EUR 10,000,000 and an indicative number of 4 grants.
HORIZON HLTH 2027 01 DISEASE 07 with a budget of EUR 37,300,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 9,000,000 to EUR 10,000,000 and an indicative number of 4 grants.
HORIZON HLTH 2027 01 DISEASE 08 with a budget of EUR 44,200,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 8,000,000 to EUR 10,000,000 and an indicative number of 5 grants.
HORIZON HLTH 2027 01 DISEASE 10 with a budget of EUR 11,800,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 3,000,000 to EUR 4,000,000 and an indicative number of 3 grants.
HORIZON HLTH 2027 01 ENVHLTH 02 with a budget of EUR 45,000,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 10,000,000 to EUR 11,000,000 and an indicative number of 4 grants.
HORIZON HLTH 2027 01 ENVHLTH MISSCLIMA 03 with a budget of EUR 20,000,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 4,000,000 to EUR 5,000,000 and an indicative number of 4 grants.
HORIZON HLTH 2027 01 IND 01 with a budget of EUR 24,500,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 6,000,000 to EUR 8,000,000 and an indicative number of 4 grants.
HORIZON HLTH 2027 01 STAYHLTH 01 with a budget of EUR 39,300,000, opening on February 10, 2027, and a deadline on April 13, 2027, with contributions ranging from EUR 6,000,000 to EUR 8,000,000 and an indicative number of 5 grants.
Partner search announcements are available for collaboration on this topic, and LEARs, Account Administrators, or self-registrants can publish partner requests. The submission system is planned to open on the date stated on the topic header.
This Horizon Europe call aims to combat the growing threat of antimicrobial resistance by funding research and innovation actions focused on developing new antibacterial and antifungal agents. It seeks to foster collaboration, particularly with SMEs and third countries, to accelerate the development and deployment of effective therapies, ultimately reducing the global burden of infectious diseases. The call encourages a comprehensive approach, from preclinical studies to clinical trials, ensuring that successful projects contribute to a stronger, more resilient healthcare system capable of addressing the challenges posed by AMR.
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Breakdown
Funding Type: Grant, specifically HORIZON-RIA (HORIZON Research and Innovation Actions) and HORIZON-PCP (HORIZON Pre-commercial Procurement).
Consortium Requirement: Not explicitly stated, but the encouragement of SME and third-country participation suggests that consortia are welcome and possibly preferred.
Beneficiary Scope (Geographic Eligibility): Eligible countries are described in Annex B of the Work Programme General Annexes. A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. Any legal entity established in the United States of America is eligible to receive Union funding. Participation of third countries where AMR bacteria and fungi in the proposal are endemic or where outbreaks have occurred or are ongoing is encouraged.
Target Sector: Health, specifically targeting antimicrobial resistance (AMR), antibacterial and antifungal agents, biotech/medtech, and pharma/healthcare.
Mentioned Countries: United States of America, third countries where AMR bacteria and fungi in the proposal are endemic or where outbreaks have occurred or are ongoing.
Project Stage: Development, validation, and clinical studies. The call specifies finalization of in-vivo tests, production of batches according to Good Manufacturing Practices (GMP), and human clinical safety and efficacy studies.
Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from €3,000,000 to €11,000,000.
HORIZON-HLTH-2027-01-CARE-02: €8,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-05: €9,000,000 to €11,000,000
HORIZON-HLTH-2027-01-DISEASE-06: €9,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-07: €9,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-08: €8,000,000 to €10,000,000
HORIZON-HLTH-2027-01-DISEASE-10: €3,000,000 to €4,000,000
HORIZON-HLTH-2027-01-ENVHLTH-02: €10,000,000 to €11,000,000
HORIZON-HLTH-2027-01-ENVHLTH-MISSCLIMA-03: €4,000,000 to €5,000,000
HORIZON-HLTH-2027-01-IND-01: €6,000,000 to €8,000,000
HORIZON-HLTH-2027-01-STAYHLTH-01: €6,000,000 to €8,000,000
Application Type: Open call, single-stage.
Nature of Support: Money, to cover research, development, clinical studies, and production costs.
Application Stages: 1, single-stage.
Success Rates: Not explicitly stated, but the indicative number of grants is provided for each topic:
HORIZON-HLTH-2027-01-CARE-02: 4 grants
HORIZON-HLTH-2027-01-DISEASE-05: 5 grants
HORIZON-HLTH-2027-01-DISEASE-06: 4 grants
HORIZON-HLTH-2027-01-DISEASE-07: 4 grants
HORIZON-HLTH-2027-01-DISEASE-08: 5 grants
HORIZON-HLTH-2027-01-DISEASE-10: 3 grants
HORIZON-HLTH-2027-01-ENVHLTH-02: 4 grants
HORIZON-HLTH-2027-01-ENVHLTH-MISSCLIMA-03: 4 grants
HORIZON-HLTH-2027-01-IND-01: 4 grants
HORIZON-HLTH-2027-01-STAYHLTH-01: 5 grants
Co-funding Requirement: Not explicitly stated, but Horizon Europe grants typically fund a significant portion of the project costs, implying that co-funding may not be mandatory but could strengthen a proposal.
Summary: This Horizon Europe call, HORIZON-HLTH-2027-01, focuses on tackling diseases and reducing disease burden, specifically targeting the development of innovative antimicrobials against pathogens resistant to antimicrobials. The call aims to support research and innovation actions (RIA) and pre-commercial procurement (PCP) projects that contribute to a better understanding of and access to new therapies for antimicrobial-resistant bacteria and fungi. The scope includes developing antibacterial and antifungal agents, including antibody-based therapies, that meet WHO innovation criteria. Projects should address in-vivo testing, GMP production, and human clinical studies, with a clear regulatory pathway for market authorization. The call encourages the participation of SMEs and third countries where AMR is endemic. The funding ranges from 3 million to 11 million euros depending on the specific topic, and the call is a single-stage application process with a deadline in April 2027. This initiative is designed to strengthen the EU's research and innovation ecosystem, support the European Medical Countermeasures Strategy, and the forthcoming Critical Medicines Act, ultimately aiming to diversify and accelerate the global research and development portfolio for AMR infections and to solidify the EU's leading role in this critical area.
Short Summary
Impact The funding aims to enhance understanding and access to innovative products for treating antimicrobial-resistant bacteria and fungi, providing candidate therapies for clinical deployment against Antimicrobial Resistance (AMR). | Impact | The funding aims to enhance understanding and access to innovative products for treating antimicrobial-resistant bacteria and fungi, providing candidate therapies for clinical deployment against Antimicrobial Resistance (AMR). |
Applicant Applicants should possess expertise in antimicrobial drug development, clinical research, and regulatory pathways, with a focus on collaboration among diverse entities including SMEs, research institutions, and healthcare organizations. | Applicant | Applicants should possess expertise in antimicrobial drug development, clinical research, and regulatory pathways, with a focus on collaboration among diverse entities including SMEs, research institutions, and healthcare organizations. |
Developments The funding will support the development of innovative antibacterial and antifungal agents, including antibody-based therapies, that meet WHO innovation criteria and address specific priority pathogens resistant to antimicrobials. | Developments | The funding will support the development of innovative antibacterial and antifungal agents, including antibody-based therapies, that meet WHO innovation criteria and address specific priority pathogens resistant to antimicrobials. |
Applicant Type This funding is designed for research institutions, universities, large enterprises, SMEs, start-ups, and healthcare organizations capable of conducting clinical studies. | Applicant Type | This funding is designed for research institutions, universities, large enterprises, SMEs, start-ups, and healthcare organizations capable of conducting clinical studies. |
Consortium The funding requires a consortium of multiple applicants, typically a minimum of three independent legal entities from different countries. | Consortium | The funding requires a consortium of multiple applicants, typically a minimum of three independent legal entities from different countries. |
Funding Amount The total budget is €44.2 million, with expected grants ranging from €8 million to €10 million per project. | Funding Amount | The total budget is €44.2 million, with expected grants ranging from €8 million to €10 million per project. |
Countries The funding is relevant for EU Member States, Associated Countries, and third countries where antimicrobial-resistant bacteria and fungi are endemic or where outbreaks have occurred, including the United States. | Countries | The funding is relevant for EU Member States, Associated Countries, and third countries where antimicrobial-resistant bacteria and fungi are endemic or where outbreaks have occurred, including the United States. |
Industry This funding targets the health and biomedical research sector, specifically focusing on antimicrobial resistance and the development of medical countermeasures. | Industry | This funding targets the health and biomedical research sector, specifically focusing on antimicrobial resistance and the development of medical countermeasures. |
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