Thirty-three European academic partners and five pharmaceutical companies are launching a new project, COMBACTE-MAGNET, under the Innovative Medicines Initiative (IMI) antimicrobial resistance research program New Drugs 4 Bad Bugs (ND4BB).
ND4BB has been launched to stimulate antibiotic development in Europe. COMBACTE-MAGNET (Combating Bacterial Resistance in Europe—Molecules Against Gram-Negative Infections) will bring highly innovative studies and activities related to prevention and treatment of infections caused by multi-drug resistant Gram-negative bacteria. University Medical Center Utrecht (the Netherlands) is the project’s managing entity.
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. There is an unmet medical need to prevent respiratory tract infections caused by the Gram-negative bacterium (GNB) Pseudomonas aeruginosa in critically ill patients and to develop new antibiotics for infections caused by MDR-GNB including, but not limited to urinary tract and intra-abdominal infections. Efforts to develop novel antibiotics are hampered by a number of scientific and regulatory hurdles that cannot be easily tackled by any individual organization working alone.
If no action is taken to address these issues, there is risk of leaving society in a situation where doctors will have few, if any, options to treat bacterial infections. To avoid a public health emergency, the entire antibiotic research community must work together to reinvigorate research into new antibiotics.
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 groundbreaking multinational phase I-III studies in adult and pediatric ICU patients with MEDI3902, MedImmune’s monoclonal antibody being investigated for the prevention of nosocomial pneumonia caused by a highly drug resistant bacterium, P. aeruginosa. In September 2014, the FDA granted Fast Track designation to MEDI3902.
In addition, the consortium will perform phase I and phase II studies, including extensive pharmacokinetic/pharmacodynamic studies, with AIC499, a new beta‐lactam antibiotic from AiCuris with enhanced beta‐lactamase stability and efficacy against a broad range of MDR-GNB, including P. aeruginosa and Acinetobacter species. Alone, or in combination with a beta‐lactamase inhibitor, AIC499 is active against MDR isolates producing a wide range of beta‐lactamases, and therefore, offers the real prospect of a new treatment option for patients with life-threatening infections due to MDR-GNBs.
COMBACTE-MAGNET will closely collaborate with and further strengthen the clinical and laboratory networks of COMBACTE, the first project within the ND4BB program that started in January 2013. Furthermore, a pan-European collaboration will be created (called EPI-Net) within COMBACTE-MAGNET to map and utilize available surveillance systems in Europe in order to optimally describe the epidemiology of antibiotic resistance and healthcare associated infections.
The COMBACTE-MAGNET consortium brings together five pharmaceutical industry partners and 33 academic partners, and is a true nexus of world class researchers from seven European countries with experience in the field of antibiotic resistance. The two European Federation of Pharmaceutical Industries and Associations (EFPIA) project sponsors, AstraZeneca, and its global biologics R&D arm MedImmune, along with AiCuris, will provide their novel, investigational infectious disease molecules MEDI3902 and AIC499 in addition to their study‐related experience.
Universities, research organizations, public bodies and nonprofit group participants include: University Medical Center Utrecht, Netherlands; University of Antwerp, Belgium; Université de Genève, Switzerland; Eberhard Karls Universität Tuebingen, Germany; Stichting Katholieke Universiteit/Radboud University Nijmegen Medical Center, the Netherlands; Servicio Andaluz de Salud, Spain; Universitaetsklinikum Freiburg, Germany; University of Oxford; Universität Ulm, Germany; University of Zurich, Switzerland; Institut de Cardiométabolisme et Nutrition, France; Consorci Institut d'Investigacions Biomèdiques August Pi i Sunyer, Spain; Center Hospitalier Universitaire Vaudois, Switzerland; Servicio Madrileño de Salud, Spain; University College London, U.K.; Pediatric European Network for the Treatment of AIDS and Infectious Diseases, U.K.; European Forum for Good Clinical Practice, Belgium; Academic Medical Center, the Netherlands; Hospital Universitario Son Espases, Spain; Center Hospitalier Universitaire de Limoges, France; Institut National de la Santé Et de la Recherche Médicinale, France; North Bristol NHS Trust; Erasmus MC, the Netherlands; University of Liverpool; TranScrip Partners, U.K.; University of Bristol; Ursula Theuretzbacher; Center for Anti-Infective Agents, Austria; Institut Català de la Salut—Hospital Universitari de Bellvitge, Catalonia, Spain; Medical University of Vienna, Austria; Assistance Publique-Hôpitaux de Paris, France; Royal Liverpool & Broadgreen University Hospitals NHS Trust; University of the West of England; Cliniques Universitaires Saint Luc, Belgium.