Despite the need for new drugs to combat infections, the reality is that only two antibiotics have come onto the market in the past three decades. The urgency to create more has given rise to Combacte, a project to promote the creation of antibiotics in Europe. Combacte is part of the New Drugs 4 Bad Bugs (ND4BB) Programme of the European Innovative Medicines Initiative (IMI), and its aim is to improve and accelerate the development of new drugs able to attack microorganisms that are not stopped by conventional treatments.
Public-private cooperation
The project consortium is made up of five pharmaceutical companies and some thirty research centres, all with experience in the field of bacterial resistance. The project is headed by the University Medical Centre of Utrecht and the clinical trials are being led by the University Hospital of Limoges. Three Catalan institutes are also taking part in the project: IDIBAPS, ISGlobal and IDIBELL. Dr Miquel Pujol, from the research group on the epidemiology of bacterial infections at IDIBELL, leads work package number 5 on complicated urinary infections. “This is a relatively common type of infection in hospitals and in the community. It used to be the most common, but it has fallen to second place with prevention measures and now respiratory infection has taken its place.” With the aim of improving patient care, the group will conduct a study on how this type of infection is managed.
«Southern Europe has very high rates of antibiotic resistance»
Unlike northern Europe, Dr Pujol notes, southern Europe has very high rates of antibiotic resistance. “This is definitely related to the consumption of antibiotics: in the north, people are sensitized to the fact that antibiotics should only be used in the appropriate circumstances. Portugal, Spain, Italy, Greece, the Balkan countries and Israel, though not in the EU, are the countries with the highest rates of antibiotic resistance to widespread bacteria such as Escherichia coli, one of the most common pathogens, or Klebsiella pneumoniae and Pseudomonas aeruginosa. Some of these microorganisms are really untreatable. They have become resistant to every antibiotic. That is why it is a priority to develop new drugs that can properly address these infections.”
A European network has been set up to achieve this aim, bringing together organizations committed to doing clinical trials to find agents that can combat resistant infections. Their efforts will adhere to the Good Clinical Practices Directive and, because the clinical process is long and cumbersome, they will use data from earlier studies in order to reduce the time and cost of clinical development. The Combacte Project also aims to design and validate tests to improve patient diagnosis, determine appropriate treatments and monitor patient response to these treatments. The backbone of the project, however, is the development of clinical trials for anti-infection medicines.
«The alarm raised by the WHO is no exaggeration: the problem is serious»
The project has a budget of 250 million euros, making it one of the most well funded public-private initiatives in history. Dr Pujol notes that the threat is so serious that the European Union and the United States have approved extraordinary appropriations to fight it. “President Obama tripled the budget for research on new antibiotics, and budgets in Europe are also being increased because, among other reasons, these are relatively common infections, especially in hospitals. The alarm raised by the WHO is no exaggeration: the problem is serious.”