Descrição

HORIZON-HLTH-2027-01-DISEASE-08

Expected Outcomes

This Horizon Europe topic supports activities contributing to the destination “Tackling diseases and reducing disease burden.” Funded proposals are expected to deliver results that achieve both of the following:

• Improve scientific and clinical understanding of, and access to, new and innovative therapies targeting antimicrobial-resistant (AMR) bacteria and fungi.
• Ensure that candidate antimicrobial treatments are available for clinical deployment, expanding therapeutic options in the fight against AMR.

Scope of the Funding

Antimicrobial resistance (AMR) is a rapidly escalating global public health threat. As bacteria and fungi evolve resistance to existing drugs, treatment effectiveness declines, leading to prolonged illness, higher mortality, increased healthcare costs, and economic losses.

This call seeks to accelerate the development of innovative antibacterial and antifungal agents, including antibody-based therapies, that meet at least one of the four World Health Organization (WHO) innovation criteria:

1. New chemical class
2. New target
3. New mode of action
4. No evidence of cross-resistance

Phage therapies are explicitly excluded from this topic.

The initiative also supports implementation of:

• The European Medical Countermeasures Strategy
• The forthcoming Critical Medicines Act
• Strengthening of the EU Research and Innovation ecosystem

Target Pathogens

Applicants must clearly specify one targeted pathogen and focus exclusively on it. Eligible pathogens include:

• Carbapenem-resistant Acinetobacter baumannii (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 species

While proposals must focus on one pathogen, research may explore broader antimicrobial effects across other bacteria or fungi.

Projects are expected to accelerate clinical testing of novel candidates, diversify the global AMR R&D pipeline, and reinforce the EU’s leadership in antimicrobial innovation.

Mandatory Research Activities

Proposals must address all of the following:

• Completion of in vivo efficacy studies in at least one animal model, or humanised immune system models where available, sufficient to progress toward clinical trials.
• Non-human primate studies, if required by regulatory authorities.
• Production of GMP-compliant batches of promising antimicrobial candidates.
• Human clinical safety and efficacy studies demonstrating a clear regulatory pathway toward market authorisation.

Clinical trials must consider key biological and social variables, including sex, age, ethnicity, disability, and vulnerability.

Participation of third countries where the targeted AMR pathogens are endemic or where outbreaks are ongoing is encouraged.

SME and Industry Participation

The call actively encourages the involvement of:

• Start-ups
• Micro, small, and medium-sized enterprises (SMEs)

Their participation is expected to strengthen innovation capacity, enhance technological foundations, and support commercial exploitation pathways.