'New Drugs for Bad Bugs' program launched

Singapore: The Innovative Medicines Initiative (IMI) is launching the first two projects under New Drugs for Bad Bugs, its antimicrobial resistance research program. The new projects, Combacte (Combatting 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 is a growing problem worldwide, and with few new drugs making it to the market, there is an urgent need for new medicines to treat resistant infections. Efforts to develop novel antibiotics are hampered by a number of scientific and regulatory hurdles that cannot be tackled by any individual organization working alone.

Mr Michel Goldman, IMI's executive director, said, "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."

IMI is the world's largest public-private partnership in healthcare. It is working to improve the environment for pharmaceutical innovation in Europe by engaging and supporting networks of industrial and academic experts in collaborative research projects.

The Combacte project is pioneering a new collaborative model that could turn out to be a new model for the clinical research and development 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.

Crucially, the Combacte team will aim 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).

For its part, 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. Drug
resistant Gram-negative bacteria are responsible for two thirds of the 25,000 deaths resulting from antimicrobial resistance reported in Europe annually.