The Innovative Medicines Initiative (IMI), the world’s largest public-private partnership in health care, has launched the first two projects under its antimicrobial resistance research program, New Drugs for Bad Bugs (ND4BB). The new projects, COMBACTE (Combating Bacterial Resistance in Europe) and TRANSLOCATION (Molecular basis of the bacterial cell wall permeability), are set to revitalize antibiotic development by promoting greater collaboration within the entire antibiotic development community, and by tackling key challenges to the development of new medicines.
“Antimicrobial resistance represents a major threat to public health worldwide. Developing new antibiotics is challenging, but by bringing together experts from pharmaceutical industry, academia and hospitals, these new projects will give a fresh impetus to the search for new weapons to fight the drug-resistant pathogens that have already killed so many in Europe and elsewhere,” said Michel Goldman, executive director, IMI.
The COMBACTE project is pioneering a new collaborative model which will hopefully result in a new model for the clinical R&D of antibiotics. This model will see academic investigators working hand in hand with industry scientists to combine knowledge and expertise, thereby increasing the probability of developing effective new medicines and addressing the public health threat of antimicrobial resistance.
A key outcome of the project will be a pan-European clinical trial network capable of recruiting patients and of conducting efficiently high quality multinational trials at all stages of development. Alongside this, the project will also establish a pan-European laboratory network to deliver epidemiological information and data from microbial surveillance work to guide the selection of clinical trial sites.
The COMBACTE team aims to generate innovative trial designs to facilitate the registration of novel antibacterial agents. It will also design and validate tests to support the diagnosis of patients, identify the most appropriate treatments, and monitor the patient’s response. COMBACTE will test its novel clinical trial designs on drugs under development in the pharmaceutical companies involved in the project, starting with a novel antibiotic that appears to be effective in respiratory and skin infections caused by multi-drug resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA).
TRANSLOCATION will focus its efforts on identifying new ways of getting antibiotics into bacteria and preventing bacteria from expelling the drugs before they can take effect. It will work primarily on Gram-negative pathogens such as Escherichia coli and Klebsiella pneumoniae.