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

The main goal of this opportunity is to develop new treatment options for patients with difficult-to-treat infections and to advance phage therapies for antibiotic-resistant bacterial diseases. It aims to provide healthcare professionals and patients with clinically useful phage therapy options, while generating reliable data on their safety and effectiveness. The opportunity encourages the use of cutting-edge scientific knowledge, the involvement of social sciences and humanities to boost societal impact, and the participation of small and medium-sized enterprises (SMEs) to strengthen innovation and commercialization. Thematic focus areas include research, innovation, and clinical studies related to phage therapy. This grant is open to applicants in the United States and eligible countries as described in the Horizon Europe Work Programme.

• Conduct a multicenter, multinational randomized controlled clinical trial (RCT) on phage-based therapies for difficult-to-treat bacterial infections.
• Target pathogens mainly linked to AMR or biofilms, with any clinical indication and route of administration.
• Use either personalised phage preparations or ready-to-use phage cocktails with strong study design.
• Include full documentation on phage characteristics and comply with EMA guidance and regulatory timelines.
• Propose a clear exploitation plan including regulatory pathway, IP, and health system integration.
• Ensure patient/citizen engagement and SSH contribution, and follow FAIR and GDPR standards for data.
• A clear plan for research, manufacturing, regulatory approval, licensing, and intellectual property is required.
• Projects must follow FAIR data standards and comply with data protection rules.
• The participation of start-ups and SMEs is encouraged.

Examples:

• A project that tests a new phage therapy for antibiotic-resistant lung infections, involving both clinical trials and patient advocacy groups.
• A collaboration between an SME and a university to develop manufacturing methods for phage-based medicines, including a clear commercialization plan.
• A study that collects and analyzes patient data on phage therapy outcomes, ensuring data is managed according to FAIR principles and GDPR.

• Personnel costs for researchers, clinicians, and support staff
• Costs for clinical trial management and patient recruitment
• Laboratory supplies and consumables
• Purchase or rental of research equipment
• Data management and analysis expenses
• Travel and accommodation for project meetings or fieldwork
• Costs for involving patient and civil society representatives
• Subcontracting specific project tasks
• Dissemination, communication, and exploitation activities
• Expenses related to regulatory submissions and scientific advice

Restrictions: All expenses must fit within the lump sum funding model and comply with the Horizon Europe Programme rules.

• Budget for this Call: 45,000,000€
• Number of Grants attributed: 3
• Budget per grant:15,000,000€

• Applicants must be legal entities established in eligible countries, including the United States.
• Entities must not be classified as high-risk suppliers of mobile network communication equipment for restricted topics.
• Applicants must demonstrate financial and operational capacity to carry out the proposed activities.
• Proposals must include, where relevant, social sciences and humanities expertise.
• Projects should involve patient and civil society representatives as appropriate.
• Applicants must follow data protection and FAIR data principles.
• Start-ups, micro, small, and medium-sized enterprises are encouraged to participate.
• Eligibility is subject to the conditions outlined in the program's annexes and guides.