Closed

Testing safety and efficacy of phage therapy for the treatment of antibiotic-resistant bacterial infections

HORIZON Research and Innovation Actions

Basic Information

Identifier
HORIZON-HLTH-2025-01-DISEASE-01
Programme
Cluster 1 - Health (Single stage - 2025)
Programme Period
2021 - 2027
Status
Closed (31094503)
Opening Date
May 22, 2025
Deadline
September 16, 2025
Deadline Model
single-stage
Budget
€40,000,000
Min Grant Amount
€6,000,000
Max Grant Amount
€8,000,000
Expected Number of Grants
5
Keywords
HORIZON-HLTH-2025-01-DISEASE-01HORIZON-HLTH-2025-01Clinical development, Phase IIClinical researchClinical trialsPrevention and treatment of infection by pathogens (e.g. vaccination, antibiotics, fungicide)Public health

Description

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, tailored towards and contributing to most of the following expected outcomes:

  • Researchers and developers make the best use of the state-of-the-art knowledge and resources for an effective development of new treatment options for patients suffering from difficult-to-treat infections.
  • Healthcare professionals and people living with difficult-to-treat infections are ultimately provided with the availability of clinically useful phage therapies.
  • Regulators are provided with quantifiable, verifiable and replicable data on safety and efficacy of phage therapy for human use and move faster towards market approval of novel phage-based therapies against antimicrobial resistant infections.
  • Citizens are engaged and informed on innovative phage-based treatments as alternative therapeutic options complementary to antibiotics.
Scope:

Antimicrobial resistance (AMR) has been identified by the United Nations (UN) General Assembly as a health Emergency in 2016. AMR is contributing to morbidity and mortality increasing the burden for society and healthcare costs. This is due to a worrying increase on the number of bacteria resistant to antibiotic treatment, causing chronic and often life-threatening infections such as wound and urinary tract infections. The World Health Organization (WHO) lists AMR among the top 10 threats for global health[1] and recognises that a lack of innovation is set to undermine antibiotic performance and health gains, with a major gap in the discovery of innovative antibacterial treatments[2].

Hence, there is an urgent need for the development of therapies to treat infections.

Bacteriophages (phages) represent a promising alternative or complement to antibiotics for the treatment of infections that do not respond to conventional treatment options. With the increase of AMR bacteria, both healthcare practitioners and innovators are expressing an increasing interest in the use of phages for the treatment of infections. As a result, the clinical use of phage therapy is expanding in the EU and beyond under different regulatory pathways, approaches and different conditions (e.g. magistral personalised phage preparations and fixed phage cocktails applied via compassionate use, named-patients based or expanded access programmes) despite a lack of large data on the efficacy of phage therapy for human use. So far, a few modest-sized randomised-controlled trials have been conducted providing indications for the safety and efficacy of the phage products, in agreement with preclinical animal studies. However, they could not always prove the efficacy of phage preparations.

Therefore, proposals should aim to develop phage-based therapies to treat bacterial infections that do not respond to conventional treatment options. For this, applicants should carry out multicenter, multinational randomised controlled clinical trial (RCT) to generate scientific evidence demonstrating safety and efficacy of phage-based therapy as stand-alone or in combination with standard-of-care (such as antibiotic or other innovative non-antibiotic-based treatment) for the treatment of difficult-to-treat bacterial infections.

Both approaches for phage therapy, personalised phage preparations or ready-to-use phage cocktails, are in scope with the call. Innovative study design, aiming at better capturing and evaluating the full potential of the benefit of personalised phage therapy, e.g. using regularly updated phage preparations, is welcome.

The topic is open to any pathogen causing difficult to treat infections mainly due to AMR or to biofilms, for any clinical indication and applying phage treatment in any route of administration. Applicants are encouraged to address pathogens listed in the WHO Bacterial Priority Pathogens List[3].

Lessons learned from previous clinical trials that failed[4] (e.g. PhagoBurn) should be considered for optimal study design, e.g. inclusions and logistics criteria, to favour success and conclusive results. The proposed trial should be designed with proper patient selection, diagnostic protocols (e.g. phagogram), production protocols (purification, stability, host selection, etc.) and treatment protocols (including dosage, repetition, duration, route of administration).

All available information about the characteristics of the phages to be used in the clinical trial should be provided (e.g. sequence, stability, targeted bacteria, registration in a phage bank or phage registry, etc.). Moreover, any additional indication of the use of phages for other applications than human use in the clinical trial (e.g. veterinary use, surface cleaning, food preservation) should be detailed in the proposal if available.

The use of computational modelling and/or artificial intelligence (AI) tools is encouraged to speed/optimise trial design, implementation and/or the analysis of large data. In the same way, the use of innovative in silico, in vitro or in vivo models to facilitate pre-clinical selection of phages to use in the clinical trial is welcome.

In their proposal applicants should describe how they take into account scientific advice or protocol assistance from the European Medicines Agency (EMA)[5]. In addition, applicants should provide a sound timeline on the trial protocol in their proposal. Furthermore, in their proposal applicants should also provide a delivery date for approval of the RCT protocol from the regulatory body(ies), which should be within 12 months from the start of the project.

Applicants should propose a clear exploitation pathway through the different necessary steps (research, manufacturing, regulatory approvals and licensing, Intellectual Property management, etc.) in order to accelerate marketing authorisation and uptake by the health systems.

The participation of start-ups, micro, small and medium-sized enterprises (SMEs)[6] is encouraged with the aim of strengthening their scientific and technological foundations, enhancing their innovation potential, and exploring possibilities for commercial exploitation.

Proposals should adhere to the FAIR[7] data principles, adopt wherever relevant, data standards and data sharing/access good practices, and apply good practices for GDPR[8] compliant personal data protection.

Sex and gender-related differences should be addressed, where relevant. To ensure that the needs of patients living with chronic infections are adequately addressed and that there is public acceptability and confidence on innovative phage-based therapies, the involvement of patient and/or civil society representatives in all phases of the research and development process is strongly encouraged. For this, the topic requires the effective contribution of social sciences and humanities (SSH) disciplines and the involvement of SSH experts, institutions as well as the inclusion of relevant SSH expertise, in order to produce meaningful and significant effects enhancing the societal impact of the related research activities.

Applicants should provide details of their clinical studies[9] 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/news-room/fact-sheets/detail/antimicrobial-resistance

[2] https://www.who.int/news/item/22-06-2022-22-06-2022-lack-of-innovation-set-to-undermine-antibiotic-performance-and-health-gains

[3] https://iris.who.int/bitstream/handle/10665/376776/9789240093461-eng.pdf?sequence=1

[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9598614

[5] https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance

[6] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32003H0361

[7] See definition of FAIR data in the introduction to this work programme part.

[8] General Data Protection Regulation: https://commission.europa.eu/law/law-topic/data-protection_en

[9] 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.

Destination & Scope

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.

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 cause the greatest amounts of premature death and disabilities and pose a major health, societal and economic threat and burden in the EU and worldwide. Many people are still suffering from these diseases and too often dying prematurely. Although many of these diseases are preventable to a large extend, only around 6% of the healthcare budgets are currently spent on preventive measures[1]. Therefore, there is the 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, taking into account sex/gender-related issues. In this regard, Research and Innovation will require international cooperation to pool the best expertise and know-how available worldwide, to access world-class research infrastructures and to leverage critical scales of investments on priority needs through a better alignment 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, to address brain health, to respond to public health needs, including 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 priorities such as the fight against non-communicable and communicable diseases, mental health and better treatment of mental, behavioural and neurodevelopmental diseases, preparedness and response to and surveillance of health threats and epidemics, reduction and treatment of the number of antimicrobial-resistant infections. In particular, the topics under this destination will support activities aiming at: i) new effective treatment options for patients suffering from antimicrobial resistant (AMR) infections; ii) innovative therapeutic interventions and complementary approaches for patients suffering from mental, behavioural and neurodevelopmental disorders; iii) new prevention and treatment options for infectious diseases with epidemic potential; iv) Artificial Intelligence (AI) based tools and technologies for pandemic preparedness and response; v) implementation research on strengthening health systems in the context of non-communicable diseases; vi) supporting the Global Research Collaboration for Infectious Disease Preparedness; vii) setting up the European Partnership for Brain Health; and viii) supporting efforts of the European Partnership fostering a European Research Area for health research (ERA4Health)[2] in particular in funding large-scale multi-country Investigator-Initiated Clinical Studies (IICS) on various health interventions addressing important public health needs.

In view of increasing the impact of EU investments under Horizon Europe, the European Commission welcomes and supports cooperation between EU-funded projects to enable cross-fertilisation and other synergies. This could range from networking to joint activities such as the participation in joint workshops, the exchange of knowledge, the development and adoption of best practices, or joint communication activities. Opportunities for potential synergies exist between projects funded under the same topic but also between other projects funded under another topic, Cluster or pillar of Horizon Europe (but also with ongoing projects funded under Horizon 2020). In particular, this could involve projects related to European health research infrastructures (under pillar I of Horizon Europe), the EIC strategic challenges on health and EIT-KIC Health (under pillar III of Horizon Europe), or in areas cutting across the health and other Clusters (under pillar II of Horizon Europe). For instance, with Cluster 3 “Civil security for society” such as on health security/emergencies (preparedness and response, medical countermeasures, epidemic outbreaks/pandemics, natural disasters and technological incidents, bioterrorism); with Cluster 4 “Digital, Industry and Space” such as on AI-based tools and technologies (e.g. detection, management and monitoring of an epidemic at population levels, and the diagnosis, treatment, and prevention at the level of individuals); or with Cluster 6 “Food, bioeconomy, natural resources, agriculture and environment” such as on antimicrobial resistance - AMR (e.g. new effective treatment options, alternatives to antibiotics).

Some Research and Innovation actions under this destination should support the mission of the European Health Emergency and Response Authority (HERA) to strengthen Europe’s ability to prevent, detect, and rapidly respond to cross-border health emergencies by ensuring the availability and access to key medical countermeasures. Furthermore, synergies will be sought between this destination and the implementation of the EU4Health Programme (2021-2027)[3]. These synergies and complementarities could be achieved, notably through mechanisms based on feedback loops, enabling on the one hand to identify policy needs that should be prioritised in Research and Innovation actions and facilitating on the other hand the implementation of research results into policy actions and clinical practice, thereby providing an integrated response across sectors and policy fields.

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 voluntary targets of the WHO Global Action Plan for the Prevention and Control of NCDs[4] 2013-2020 are attained (by 2025), with an immediate impact on the related disease burden (Disability-Adjusted Life Years - DALYs)[5],[6],[7].
  • 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[8],[9].
  • 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).

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[10] 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] 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

[2] https://era4health.eu

[3] https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en

[4] Non-communicable diseases

[5] https://www.who.int/publications/i/item/9789241506236

[6] Including for instance the following voluntary targets (against the 2010 baseline): A 25% relative reduction in the overall mortality from cardiovascular diseases, cancer, diabetes, or chronic respiratory diseases; Halt the rise in diabetes and obesity; An 80% availability of the affordable basic technologies and essential medicines, including generics, required to treat major non-communicable diseases in both public and private facilities.

[7] 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.

[8] WHO global action plan on antimicrobial resistance, 2015

[9] EU One Health Action Plan against AMR, 2017

[10] 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).

Eligibility & Conditions

General conditions

1. Admissibility Conditions, Proposal page limit and layout

Admissibility Conditions are described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes.

Proposal page limits and layout are described in Part B of the Application Form available in the Submission System.



2. Eligible Countries

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. See the information in the Horizon Europe Programme Guide.



3. Other Eligible Conditions

In recognition of the opening of the US National Institutes of Health’s programmes to European researchers, any legal entity established in the United States of America is eligible to receive Union funding.

If projects use satellite-based earth observation, positioning, navigation and/or related timing data and services, beneficiaries must make use of Copernicus and/or Galileo/EGNOS (other data and services may additionally be used).

The following exceptions apply: subject to restrictions for the protection of European communication networks.

Other Eligible Conditions are described in Annex B of the Work Programme General Annexes.



4. Financial and operational capacity and exclusion

Financial and operational capacity and exclusion are described in Annex C of the Work Programme General Annexes.



5a. Evaluation and award: Award criteria, scoring and thresholds

Evaluation and award: Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes.

5b. Evaluation and award: Submission and evaluation processes

The thresholds for each criterion will be 4 (Excellence), 4 (Impact) and 4 (Implementation). The cumulative threshold will be 12.

Evaluation and award: Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual.

5c. Evaluation and award: Indicative timeline for evaluation and grant agreement

Evaluation and award: Indicative timeline for evaluation and grant agreement are described in Annex F of the Work Programme General Annexes.



6. Legal and financial set-up of the grants

Eligible costs will take the form of a lump sum as defined in the Decision of 7 July 2021 authorising the use of lump sum contributions under the Horizon Europe Programme – the Framework Programme for Research and Innovation (2021-2027) – and in actions under the Research and Training Programme of the European Atomic Energy Community (2021-2025) [[This decision is available on the Funding and Tenders Portal, in the reference documents section for Horizon Europe, under ‘Simplified costs decisions’ or through this link: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/horizon/guidance/ls-decision_he_en.pdf]].

Legal and financial set-up of the grants are described in Annex G of the Work Programme General Annexes.



Specific conditions

Specific conditions are described in the specific topic of the Work Programme.



Support & Resources

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Latest Updates

Last Changed: September 26, 2025

Call HORIZON-HLTH-2025-01 closed on 16 September 2025. 749 proposals were submitted. The breakdown per topic is:

  • HORIZON-HLTH-2025-01-DISEASE-01: 30 proposals
  • HORIZON-HLTH-2025-01-DISEASE-03: 15 proposals
  • HORIZON-HLTH-2025-01-DISEASE-04: 76 proposals
  • HORIZON-HLTH-2025-01-DISEASE-05: 7 proposals
  • HORIZON-HLTH-2025-01-DISEASE-06: 158 proposals
  • HORIZON-HLTH-2025-01-DISEASE-07: 83 proposals
  • HORIZON-HLTH-2025-01-CARE-01: 118 proposals
  • HORIZON-HLTH-2025-01-TOOL-01: 57 proposals
  • HORIZON-HLTH-2025-01-TOOL-02: 35 proposals
  • HORIZON-HLTH-2025-01-TOOL-03: 82 proposals
  • HORIZON-HLTH-2025-01-TOOL-05: 25 proposals
  • HORIZON-HLTH-2025-01-IND-01: 58 proposals
  • HORIZON-HLTH-2025-01-IND-02: 5 proposals

Evaluation results are expected to be communicated on Wednesday 21 January 2026 at the earliest.

Last Changed: June 10, 2025

Please note that due to a technical issue, during the first days of publication of this call, the topic page did not display the description of the corresponding destination. This problem is now solved. In addition to the information published in the topic page, you can always find a full description of the relevant destination in the Work Programme 2025 part for "Health". Please select from the work programme the destination relevant to your topic and take into account the description and expected impacts of that destination for the preparation of your proposal.

Last Changed: May 22, 2025
The submission session is now available for: HORIZON-HLTH-2025-01-DISEASE-05, HORIZON-HLTH-2025-01-DISEASE-03, HORIZON-HLTH-2025-01-TOOL-05, HORIZON-HLTH-2025-01-DISEASE-07, HORIZON-HLTH-2025-01-TOOL-03, HORIZON-HLTH-2025-01-IND-02, HORIZON-HLTH-2025-01-DISEASE-01, HORIZON-HLTH-2025-01-DISEASE-04, HORIZON-HLTH-2025-01-CARE-01, HORIZON-HLTH-2025-01-TOOL-02, HORIZON-HLTH-2025-01-TOOL-01, HORIZON-HLTH-2025-01-IND-01, HORIZON-HLTH-2025-01-DISEASE-06
Testing safety and efficacy of phage therapy for the treatment of antibiotic-resistant bacterial infections | Grantalist