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

This EU grant opportunity, titled HORIZON HLTH 2025 01 DISEASE 01, focuses on evaluating the safety and efficacy of phage therapy for treating antibiotic-resistant bacterial infections. It is part of the Horizon Europe initiative, specifically within the Health Cluster. The grant operates under a single-stage open call for proposals with applications accepted until September 16, 2025. This opportunity utilizes a lump sum funding model and is classified as a HORIZON RIA (Research and Innovation Action).

Eligible applicants include research institutions, universities, small and medium-sized enterprises (SMEs), startups, and industrial developers from EU member states or associated countries. The involvement of social sciences and humanities experts, along with patient and civil society representatives, is encouraged. Legal entities from the United States are also eligible for funding.

The geographic scope covers EU member states and associated countries, with the potential for participation from non-EU/non-associated countries under specific provisions. The target sector for this grant is health, particularly focused on addressing antimicrobial resistance (AMR) and difficult-to-treat infections, highlighting biotech and medtech innovations, as well as the pharmaceutical sector. The scope specifically encourages multicenter, randomized controlled clinical trials (RCTs) to generate substantial evidence of phage therapy's effectiveness.

Projects aiming for funding should generate results demonstrating the optimal use of resources for new treatment options, clinical applicability of phage therapies, and provide regulatory authorities with the necessary data for market approvals. Innovative study designs are highly encouraged, with the aim of producing both personalized phage preparations and ready-to-use phage cocktails.

The funding amount allotted per project is approximately €15 million, with a total budget of €45 million set to support three projects. Application processes involve a single stage and a clear exploitation pathway for research results is required to facilitate market authorization and broader healthcare system uptake.

The specifics of eligibility criteria, evaluation metrics, and detailed application instructions are outlined in various annexes of the Horizon Europe Work Programme. Although success rates are not explicitly indicated, Horizon Europe typically sees average success rates between 10% and 39% for related health topics. The overall vision of the funding opportunity is to combat the pressing public health challenge posed by AMR through innovative phage therapies, involving collaborative multinational efforts in clinical research.

This EU grant opportunity, HORIZON HLTH 2025 01 DISEASE 01, focuses on "Testing safety and efficacy of phage therapy for the treatment of antibiotic-resistant bacterial infections." It falls under the Horizon Europe (HORIZON) program, specifically the Cluster 1 Health call, and is a single stage call for proposals. The type of action is a HORIZON RIA (Research and Innovation Action) with a HORIZON Lump Sum Grant (HORIZON AG LS) model grant agreement. The call opened for submission on May 22, 2025, and the deadline for submission is September 16, 2025, at 17:00:00 Brussels time.

The primary goal of this topic is to support activities that contribute to "Tackling diseases and reducing disease burden." Proposals should aim to deliver results that lead to:

1. Optimal use of knowledge and resources by researchers and developers for new treatment options for difficult to treat infections.
2. Availability of clinically useful phage therapies for healthcare professionals and patients.
3. Provision of quantifiable data on phage therapy safety and efficacy to regulators, accelerating market approval.
4. Engagement and education of citizens regarding phage-based treatments as antibiotic alternatives.

The scope of the grant addresses the urgent need for new therapies due to the rise of antimicrobial resistance (AMR), which the UN General Assembly declared a health emergency in 2016. AMR increases morbidity, mortality, and healthcare costs due to bacteria resistant to antibiotics. Bacteriophages (phages) are presented as a promising alternative or complement to antibiotics.

Funded projects must conduct multicenter, multinational randomized controlled clinical trials (RCTs) to demonstrate the safety and efficacy of phage-based therapies, either alone or combined with standard treatments, for difficult to treat bacterial infections. Both personalized phage preparations and ready to use phage cocktails are considered. Innovative study designs that evaluate the benefits of personalized phage therapy are encouraged.

The grant is open to any pathogen causing difficult to treat infections due to AMR or biofilms, for any clinical indication, and any route of phage administration. Applicants are encouraged to target pathogens on the WHO Bacterial Priority Pathogens List.

Proposals should consider lessons from failed clinical trials like PhagoBurn to optimize study design, including patient selection, diagnostic protocols (e.g., phagogram), production protocols (purification, stability, host selection), and treatment protocols (dosage, repetition, duration, route of administration).

Applicants must provide all available information on the phages used in the clinical trial, such as sequence, stability, targeted bacteria, and registration in phage banks. Any additional uses of the phages (e.g., veterinary, surface cleaning, food preservation) should also be detailed.

The use of computational modeling, artificial intelligence (AI), in silico, in vitro, and in vivo models is encouraged to optimize trial design, implementation, data analysis, and phage selection.

Applicants should describe how they have considered scientific advice or protocol assistance from the European Medicines Agency (EMA) and provide a timeline for the trial protocol. A delivery date for RCT protocol approval from regulatory bodies within 12 months of project start is required.

A clear exploitation pathway for research, manufacturing, regulatory approvals, licensing, and Intellectual Property management is expected to accelerate marketing authorization and health system uptake.

Participation of start ups, micro, small, and medium sized enterprises (SMEs) is encouraged to strengthen their scientific and technological foundations and commercial potential.

Proposals must adhere to FAIR data principles, relevant data standards, data sharing practices, and GDPR compliant personal data protection. Sex and gender related differences should be addressed. The involvement of patient and civil society representatives, social sciences, and humanities (SSH) experts is strongly encouraged.

Applicants must provide details of their clinical studies in a dedicated annex using the provided template.

The 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. Eligible countries are described in Annex B of the Work Programme General Annexes. Legal entities established in the United States of America are eligible to receive Union funding. Projects using satellite data must use Copernicus and/or Galileo/EGNOS. Other eligible conditions are described in Annex B, and financial and operational capacity and exclusion criteria are in Annex C of the Work Programme General Annexes.

Evaluation and award criteria, scoring, and thresholds are in Annex D of the Work Programme General Annexes. The thresholds for each criterion are 4 (Excellence), 4 (Impact), and 4 (Implementation), with a cumulative threshold of 12. Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual. The indicative timeline for evaluation and grant agreement is also in Annex F.

Eligible costs will be in the form of a lump sum, as defined in the Decision of 7 July 2021. The legal and financial setup of the grants are described in Annex G of the Work Programme General Annexes. Specific conditions are described in the specific topic of the Work Programme.

Application and evaluation form templates, guidance documents, model grant agreements, and call specific instructions are available in the Submission System and the Funding & Tenders Portal.

The total budget for this topic is 45,000,000 EUR, and the indicative number of grants to be awarded is 3, with contributions of around 15,000,000 EUR per grant.

This grant opportunity seeks to combat the growing threat of antimicrobial resistance by funding the development and clinical testing of phage-based therapies. It encourages researchers, healthcare professionals, and SMEs to collaborate on multinational clinical trials, adhering to rigorous data standards and regulatory guidelines, to bring innovative phage therapies to market and improve patient outcomes. The emphasis on involving patients, considering gender differences, and utilizing advanced technologies like AI underscores the comprehensive approach required to address this global health challenge. The lump sum funding model and the encouragement of SME participation aim to streamline the process and foster innovation in this critical area of healthcare.

Eligible Applicant Types: The eligible applicant types for this opportunity include start-ups, micro enterprises, small and medium-sized enterprises (SMEs), research institutions, healthcare practitioners, innovators, and patient or civil society representatives. The participation of social sciences and humanities (SSH) experts and institutions is also encouraged. Any legal entity established in the United States of America is also eligible to receive Union funding.

Funding Type: The funding type for this opportunity is a grant, specifically a HORIZON Research and Innovation Action (HORIZON-RIA) or a HORIZON Innovation Action (HORIZON-IA) using a lump sum grant agreement. There are also Coordination and Support Actions (CSA).

Consortium Requirement: This opportunity requires a consortium of multiple applicants, as it involves multicenter, multinational randomised controlled clinical trials (RCTs).

Beneficiary Scope (Geographic Eligibility): The geographic eligibility includes EU member states, associated countries, and potentially non-EU/non-associated countries with specific provisions. Legal entities established in the United States of America are also eligible.

Target Sector: The target sector is health, specifically focusing on tackling diseases and reducing disease burden, with an emphasis on antimicrobial resistance (AMR) and difficult-to-treat bacterial infections. The program targets the biotech/medtech, pharma/healthcare, artificial intelligence, and innovation sectors.

Mentioned Countries: United States of America is explicitly mentioned as eligible. The opportunity is broadly aimed at EU member states and associated countries.

Project Stage: The project stage is primarily at the clinical trial stage, specifically focusing on multicenter, multinational randomised controlled clinical trials (RCTs). The projects should aim to generate scientific evidence demonstrating the safety and efficacy of phage-based therapy.

Funding Amount: The funding amounts vary depending on the specific topic within the call, ranging from €2,000,000 for Coordination and Support Actions (CSA) to €80,000,000 for Research and Innovation Actions (RIA). Individual contributions range from around €2,000,000 to between €15,000,000 and €20,000,000 for some Research and Innovation Actions.

Application Type: The application type is an open call with a single-stage submission process.

Nature of Support: Beneficiaries will receive money in the form of a lump sum grant.

Application Stages: The application process involves a single stage.

Success Rates: The indicative number of grants varies depending on the specific topic, ranging from 1 to 10 grants per topic. This suggests varying success rates depending on the level of competition within each topic.

Co-funding Requirement: The information provided does not explicitly state a co-funding requirement. However, Horizon Europe projects often encourage or require some level of co-funding, which should be verified in the specific call documents.

Summary: This Horizon Europe funding opportunity aims to combat antimicrobial resistance (AMR) by supporting the development and clinical testing of phage-based therapies for difficult-to-treat bacterial infections. The call encourages multinational consortia, including SMEs, start-ups, and research institutions, to conduct multicenter, randomised controlled clinical trials (RCTs) to generate robust evidence on the safety and efficacy of phage therapies. The scope covers both personalised phage preparations and ready-to-use phage cocktails, welcoming innovative study designs and the use of AI and computational modelling. The ultimate goal is to provide healthcare professionals and patients with clinically useful phage therapies, to provide regulators with the data needed for market approval, and to engage citizens in understanding these innovative treatments. The funding is provided as a lump sum, and applicants must propose a clear exploitation pathway for their research results. The call is structured around several topics, each with a specific budget and indicative number of grants, ranging from coordination and support actions to large-scale research and innovation actions.