Brussels, Belgium, 18 November 2015 - Antibiotic-resistant bacteria kill 25 000 people in the EU every year, and cost the economy €1.5 billion. The Innovative Medicines Initiative (IMI) programme New Drugs 4 Bad Bugs (ND4BB) represents an unprecedented partnership between industry, academia and biotech organisations to combat antibiotic resistance in Europe by tackling the scientific, regulatory, and business challenges that are hampering the development of new antibiotics. The programme currently comprises seven projects that are now starting to deliver on their promise of re-invigorating antibiotic research and development. Published to coincide with European Antibiotic Awareness Day 2015, this article and the associated factsheet offer an overview of the programme and a summary of the projects' successes so far.
The first projects kicked off in early 2013, and the programme now encompasses seven projects that are starting to deliver exciting results in diverse aspects of antibiotic development. Many projects focus on a group of bacteria called Gram-negative bacteria, which are notoriously tough to treat and are responsible for two thirds of the 25 000 deaths resulting from antimicrobial resistance reported in Europe annually. The total budget of the programme now stands at around €700 million.
The successes of the projects are summarised below. More details can be found in this factsheet
TRANSLOCATION – getting drugs into bugs (and keeping them there)
- Development of new techniques to analyse the uptake of antibiotics by bacteria.
- Worked out the structure of 20 proteins found in the membranes of bacteria that cause many infections. These proteins play a vital role transporting substances (including, potentially, antibiotics) into and out of bacterial cells.
- Greater understanding of the workings of efflux pumps (which bacteria use to expel antibiotics).
- Creation of a database to gather data from both new antibiotic research projects and abandoned ones.
ENABLE - Building a drug discovery platform for antibiotics
- Since the project started in February 2014, 50 anti-infective programmes have applied to join the project to benefit from the platform.
- So far, 10 programmes (7 from small biotechs) have been selected to join the project. Of these, 5 remain active, having been identified as having the highest likelihood of succeeding in the clinic.
- There are more programmes in the pipeline. The project has a rolling open Call for proposals and the ENABLE team is continually reviewing submissions.
- The project has attracted the interest of SMEs working on antibiotic development both in Europe and beyond
The COMBACTE project family - Establishing a pan-European network of clinical sites
- The CLIN-Net hospital network includes 549 hospitals in 344 cities in 38 countries in Europe. The project is now cataloguing these and, where necessary providing training to ensure all are qualified to run high quality clinical studies.
- The LAB-Net network counts 3-400 laboratories in around 38 countries.
- The network is actively involved in setting up and carrying out the SAATELLITE study, which is investigating a drug called MEDI4893. MEDI4893 targets a toxin produced by Staphylococcus aureus, a bacteria often associated with hospital‐associated infections and linked to resistance issues. So far the SAATELLITE study covers 51 sites in 8 countries. Some 39 patients have been enrolled so far.
- Another study that draws on the network is ASPIRE. ASPIRE aims to add to our understanding of the incidence and causes of health-care associated infections (HAIs) caused by two bugs: S. aureus and Pseudomonas aeruginosa. Patient recruitment started in June this year at a site in the Netherlands, and the project team is now busy adding further sites to the study.
- Plans for further clinical studies are being finalised.
DRIVE-AB - New economic models for antibiotic development
- DRIVE-AB scientists discovered that a 30% drop in the efficacy of antibiotics could result in 120 000 additional infections and 6 300 deaths per year in the US alone among people who undergo common surgeries and chemotherapy treatments. The findings were published in the Lancet Infectious Diseases.
- The project is well represented in a new series of papers entitled ‘Antimicrobials: sustainable access and effectiveness’ that will be published by The Lancet on 18 November 2015.