Testing safety and efficacy of phage therapy for the treatment of antibiotic-resistant bacterial infections
Horizon Europe 2025 Health Cluster – Tackling diseases and reducing disease burden
Funding Amount
Amount not specified
Deadline
16/09/2025
Eligible Organization Types
Non-profit, Private Business, Research Institution, Public Institution
Trusted by
What is the Testing safety and efficacy of phage therapy for the treatment of antibiotic-resistant bacterial infections Call?
Grant Description
This call supports multicenter, multinational randomised controlled clinical trials to generate robust safety and efficacy evidence for phage-based therapies treating difficult-to-treat bacterial infections driven by antimicrobial resistance. It aims to accelerate regulatory approval and uptake of novel phage treatments—both personalised and fixed cocktails—by involving patients, social science experts and stakeholders, and ensuring data conform to FAIR and GDPR principles.
Required Results for Successful Funding
Expected Outcomes
Proposals should deliver results contributing to the following outcomes:
• Researchers and developers leverage state-of-the-art knowledge, resources and infrastructure to advance the development of innovative phage-based treatment options for patients with difficult-to-treat infections.
• Healthcare professionals and patients benefit from the availability of clinically validated phage therapies, improving treatment options for AMR and biofilm-associated infections.
• Regulatory authorities receive robust, quantifiable, verifiable and replicable data on phage therapy safety and efficacy, facilitating accelerated market approval of novel phage-based antimicrobials.
• Citizens are informed, engaged and empowered regarding phage-based treatments as complementary or alternative options to antibiotics, enhancing public awareness and acceptability of innovative antimicrobial strategies.
• Researchers and developers leverage state-of-the-art knowledge, resources and infrastructure to advance the development of innovative phage-based treatment options for patients with difficult-to-treat infections.
• Healthcare professionals and patients benefit from the availability of clinically validated phage therapies, improving treatment options for AMR and biofilm-associated infections.
• Regulatory authorities receive robust, quantifiable, verifiable and replicable data on phage therapy safety and efficacy, facilitating accelerated market approval of novel phage-based antimicrobials.
• Citizens are informed, engaged and empowered regarding phage-based treatments as complementary or alternative options to antibiotics, enhancing public awareness and acceptability of innovative antimicrobial strategies.
Funded areas
Scope Requirements
Proposals must strictly adhere to the following scope criteria:
• Focus on bacterial infections that are difficult to treat due to antimicrobial resistance (AMR) or biofilm formation, for any clinical indication and via any administration route.
• Target pathogens listed in the WHO Bacterial Priority Pathogens List, while remaining open to other high-priority or emerging AMR organisms.
• Conduct a multicentre, multinational RCT testing either personalised phage preparations or ready-to-use phage cocktails, alone or combined with standard-of-care.
• Incorporate lessons learned from previous failed trials (e.g. PhagoBurn) to optimise inclusion/exclusion criteria, logistics, endpoint selection and trial feasibility.
• Implement rigorous patient selection processes, standardised diagnostic assays (phagograms), and harmonised production and treatment protocols.
• Provide full characterisation of phage candidates (genomic sequences, stability data, host range, repository registration) and report any ancillary phage applications if available.
• Leverage computational modelling and AI for trial design, patient stratification and data analytics, and/or develop innovative pre-clinical in silico, in vitro or in vivo models for phage screening.
• Describe how EMA scientific advice or protocol assistance has been sought and include a detailed timeline for protocol development and regulatory submission, ensuring approval within 12 months of project initiation.
• Present a robust exploitation plan detailing the pathway from research findings to manufacturing, regulatory approval, market authorisation and health-system integration, including IP management.
• Demonstrate active involvement of SMEs, start-ups and micro-enterprises to bolster innovation capacity and commercial exploitation.
• Commit to FAIR data management, relevant data standards and GDPR-compliant handling of personal data.
• Address sex and gender differences in study design and analysis where applicable.
• Integrate social sciences and humanities research and involve patient and civil society representatives to ensure acceptability and maximise societal impact.
• Use the provided clinical studies template to supply comprehensive study details in the submission annex.
• Focus on bacterial infections that are difficult to treat due to antimicrobial resistance (AMR) or biofilm formation, for any clinical indication and via any administration route.
• Target pathogens listed in the WHO Bacterial Priority Pathogens List, while remaining open to other high-priority or emerging AMR organisms.
• Conduct a multicentre, multinational RCT testing either personalised phage preparations or ready-to-use phage cocktails, alone or combined with standard-of-care.
• Incorporate lessons learned from previous failed trials (e.g. PhagoBurn) to optimise inclusion/exclusion criteria, logistics, endpoint selection and trial feasibility.
• Implement rigorous patient selection processes, standardised diagnostic assays (phagograms), and harmonised production and treatment protocols.
• Provide full characterisation of phage candidates (genomic sequences, stability data, host range, repository registration) and report any ancillary phage applications if available.
• Leverage computational modelling and AI for trial design, patient stratification and data analytics, and/or develop innovative pre-clinical in silico, in vitro or in vivo models for phage screening.
• Describe how EMA scientific advice or protocol assistance has been sought and include a detailed timeline for protocol development and regulatory submission, ensuring approval within 12 months of project initiation.
• Present a robust exploitation plan detailing the pathway from research findings to manufacturing, regulatory approval, market authorisation and health-system integration, including IP management.
• Demonstrate active involvement of SMEs, start-ups and micro-enterprises to bolster innovation capacity and commercial exploitation.
• Commit to FAIR data management, relevant data standards and GDPR-compliant handling of personal data.
• Address sex and gender differences in study design and analysis where applicable.
• Integrate social sciences and humanities research and involve patient and civil society representatives to ensure acceptability and maximise societal impact.
• Use the provided clinical studies template to supply comprehensive study details in the submission annex.
Additional Conditions for Applicants
Special Conditions
- Type of action: Horizon Europe Research and Innovation Action (RIA) under the lump-sum grant model (HORIZON-AG-LS).
• Single-stage submission by 16 September 2025, 17:00 Brussels time; opening date 22 May 2025.
• Eligible costs covered as lump sum in accordance with the 7 July 2021 Decision on lump sums under Horizon Europe.
• Proposals must include the dedicated clinical studies annex using the template provided; use of the template is mandatory.
• Applicants must deliver a regulatory-approved RCT protocol (from relevant bodies, e.g. national agencies or EMA) within 12 months of project start.
• Entities assessed as “high-risk suppliers” of mobile network communication equipment are not eligible for participation.
• Any legal entity established in the United States of America is eligible for Union funding.
• Projects using satellite-based earth observation or positioning data must use Copernicus and/or Galileo/EGNOS services.
• Proposals must comply with Horizon Europe Work Programme General Annexes A–H (admissibility, eligibility, financial and operational capacity, exclusion, evaluation, MGA conditions).
• Data management must fulfil FAIR principles and GDPR requirements.
• Sex and gender analysis, SSH involvement and patient/civil society engagement are strongly encouraged and expected where relevant.
• Single-stage submission by 16 September 2025, 17:00 Brussels time; opening date 22 May 2025.
• Eligible costs covered as lump sum in accordance with the 7 July 2021 Decision on lump sums under Horizon Europe.
• Proposals must include the dedicated clinical studies annex using the template provided; use of the template is mandatory.
• Applicants must deliver a regulatory-approved RCT protocol (from relevant bodies, e.g. national agencies or EMA) within 12 months of project start.
• Entities assessed as “high-risk suppliers” of mobile network communication equipment are not eligible for participation.
• Any legal entity established in the United States of America is eligible for Union funding.
• Projects using satellite-based earth observation or positioning data must use Copernicus and/or Galileo/EGNOS services.
• Proposals must comply with Horizon Europe Work Programme General Annexes A–H (admissibility, eligibility, financial and operational capacity, exclusion, evaluation, MGA conditions).
• Data management must fulfil FAIR principles and GDPR requirements.
• Sex and gender analysis, SSH involvement and patient/civil society engagement are strongly encouraged and expected where relevant.
Important dates
Open from: 22/05/2025
Deadline:16/09/2025
Application period has ended
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