- Innovative Medicines Initiative (IMI) New Drugs 4 Bad Bugs programme represents an unprecedented partnership between industry and academia to combat antibiotic resistance in Europe.
- Antibiotic-resistant bacteria cause approximately 25 000 deaths in the EU, with two thirds of these deaths due to Gram-Negative bacteria and costing the European economy an estimated €1.5 billion per year.
- €167 million COMBACTE-MAGNET project aims - during the 7-year project time - to create new approaches in clinical research and to develop two innovative antibacterial molecules to address antibacterial resistance against the most problematic of drug-resistant pathogens, the Gram-negative bacteria.
Utrecht (the Netherlands), February 3, 2015 – Today 33 European academic partners and 5 pharmaceutical companies are launching a new project, COMBACTE-MAGNET, under the IMI antimicrobial resistance research programme New Drugs 4 Bad Bugs (ND4BB). ND4BB has been launched to stimulate antibiotic development in Europe. COMBACTE-MAGNET (Combatting 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 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, we risk 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.
Professor Marc Bonten, University Medical Center Utrecht: “COMBACTE MAGNET is a new, highly innovative research programme in which academic and industrial partners are collaborating to combat the threat of antibiotic resistance for patients worldwide.” 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 1, 2 and 3 studies in adult and paediatric ICU patients with MEDI3902, MedImmune’s monoclonal antibody being investigated for the prevention of nosocomial pneumonia caused by a highly drug resistant bacterium, Pseudomonas 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: “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.” In addition, the consortium will perform phase 1 and phase 2 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 MDRGNB, 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 programme 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.
IMI Acting Executive Director Irene Norstedt: “COMBACTE-MAGNET is an important addition to the IMI's antimicrobial resistance research programme ‘New Drugs 4 Bad Bugs’. By supporting these projects, which together addresses the scientific, regulatory and economic challenges of antibiotic development, IMI hopes to be able to advance the development of new, life-saving antibiotics.”
The COMBACTE-MAGNET consortium brings together 5 pharmaceutical industry partners and 33 academic partners, and is a true nexus of world class researchers from 7 European countries with expertise in the field of antibiotic resistance. The two European Federation of Pharmaceutical Industries and Associations (EFPIA) project sponsors, AstraZeneca, and its global biologics research and development arm MedImmune, along with AiCuris, will provide their novel, investigational infectious disease molecules MEDI3902 and AIC499 in addition to their study‐related expertise.
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About University Medical Center Utrecht
University Medical Center Utrecht (UMC Utrecht) belongs to the largest public healthcare institutions in the Netherlands. It was created in 2000 through the merger of Utrecht Academic Hospital, Wilhelmina Children’s Hospital and the Medical Faculty of Utrecht University. UMC Utrecht has the ambition to be a leading international healthcare provider, medical school and research institute that is exciting for its people, attractive to talent and embodies a culture of teamwork, innovation, sustainability and high performance. As a patient-centered organization, its 11,000 employees are dedicated to prevent disease, improve healthcare, develop new treatment methods and refine existing ones, with patient safety and quality as cornerstones. Strategic research programs are Brain, Child Health, Circulatory Health, Infection & Immunity, Personalized Cancer Care and Regenerative Medicine & Stem Cells. UMC Utrecht is embedded in a vibrant and entrepreneurial science community where knowledge about health, disease and healthcare is generated, validated, shared and applied. For more information, visit www.umcutrecht.nl or follow us on Twitter @UMCU_INTL.
About IMI ND4BB programma
Antibiotic-resistant bacteria kill 25 000 people in the EU every year, and cost the economy €1.5 billion. Innovative Medicines Initiative (IMI) New Drugs 4 Bad Bugs (ND4BB) programme 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. For more information on COMBACTE MAGNET, visit www.combacte.com. For more information on IMI, visit www.imi.europa.com.
* Participants COMBACTE-MAGNET
Universities, research organizations, public bodies, non-profit groups:
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 Centre, The Netherlands; Servicio Andaluz de Salud, Spain; Universitaetsklinikum Freiburg, Germany; University of Oxford, UK; Universität Ulm, Germany; University of Zurich, Switzerland; Institut de Cardiométabolisme et Nutrition, France; Consorci Institut d'Investigacions Biomèdiques August Pi i Sunyer, Spain; Centre Hospitalier Universitaire Vaudois, Switzerland; Servicio Madrileño de Salud, Spain; University College London, UK; Paediatric European Network for the Treatment of AIDS and Infectious Diseases, UK; European Forum for Good Clinical Practice, Belgium; Academic Medical Center, The Netherlands; Hospital Universitario Son Espases, Spain; Centre Hospitalier Universitaire de Limoges, France; Institut National de la Santé Et de la Recherche Médicinale, France; North Bristol NHS Trust, UK; Erasmus MC, The Netherlands;University of Liverpool, UK; TranScrip Partners LLP, UK; University of Bristol, UK; 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, UK; University of the West of England, UK; Cliniques Universitaires Saint Luc, Belgium
AstraZeneca / MedImmune, UK; AiCuris GmbH & Co., Germany; GlaxoSmithKline Research and Development Ltd, UK; Basilea Pharmaceutica International, Switzerland; Sanofi, France