Seven-year project brings together 33 European academic partners and five pharmaceutical companies
European academic partners and pharmaceutical companies have come together in a new project to stimulate antibiotic development in Europe.
Called COMBACTE-MAGNET (Combatting Bacterial Resistance in Europe – Molecules Against Gram-Negative Infections), the €167m, seven-year project will bring innovative studies and activities related to the prevention and treatment of infections caused by multi-drug resistant Gram-negative bacteria.
The collaboration, under the Innovative Medicines Initiative (IMI) antimicrobial resistance research programme New Drugs 4 Bad Bugs (ND4BB), brings together 33 European academic partners and five pharmaceutical firms and will be managed by University Medical Center Utrecht.
It is well-known that antimicrobial resistance (AMR) is a growing problem worldwide, and with few new drugs making it to the market, there is an urgent need for new medicines to manage infections caused by resistant pathogens. In this respect, most troublesome is the rapid emergence and dissemination of multidrug resistant (MDR) bacteria.
COMBACTE-MAGNET is an innovative model for anti-infective development
There is an unmet medical need to prevent respiratory tract infections caused by the Gram-negative bacterium (GNB) Pseudomonas aeruginosa and to develop new antibiotics for infections caused by MDR-GNB including urinary tract and intra-abdominal infections. Efforts to develop novel antibiotics are said to be hampered by a number of scientific and regulatory hurdles that cannot be tackled easily by any individual organisation working alone.
The COMBACTE-MAGNET project will investigate a new approach for preventing respiratory infections in intensive care unit (ICU) patients and new treatment options for patients with life-threatening infections due to MDR-GNB.
The project will deliver multinational Phase I, II and III studies in adult and paediatric ICU patients with MEDI3902, MedImmune’s monoclonal antibody being investigated for the prevention of nosocomial pneumonia caused by P. aeruginosa. In September 2014, the US Food & Drug Administration granted Fast Track designation to MEDI3902.
Hasan Jafri, COMBACTE-MAGNET Coordinator, Senior Director, Clinical Research and Development, Infectious Disease & Vaccines at MedImmune, said: 'As part of MedImmune’s commitment to bringing novel and effective biologic anti-infectives to patients, collaboration with world-renowned academic partners, such as those involved with COMBACTE-MAGNET, makes the most sense. It is an innovative model for anti-infective development.'
The consortium will also carry out Phase I and Phase II studies, including extensive pharmacokinetic/pharmacodynamic studies, with AIC499, a new beta‐lactam antibiotic from AiCuris of Germany.
COMBACTE-MAGNET will collaborate with and further strengthen the clinical and laboratory networks of COMBACTE, the first project within the ND4BB programme that started in January 2013.
In addition, a pan-European collaboration will be created (called EPI-Net) within COMBACTE-MAGNET to map and use available surveillance systems in Europe to describe the epidemiology of antibiotic resistance and healthcare associated infections.