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UTRECHT, Netherlands, April 11, 2019 / PRNewswire / – COMBACT-NET funded by the Innovative Medicines Initiative (IMI) (Combat bacterial resistance in Europe ) the consortium completed the SAATELLITE study, a phase II trial of suvratoxumab, a novel monoclonal antibody (mAb) targeting staphylococcus aureus. The trial, sponsored by AstraZeneca and part of the Innovative Medicines Initiative (IMI) program, badessed the ability of the new monoclonal antibody to prevent Staphylococcus aureus Acute ventilator (PVA) pneumonia in mechanically ventilated patients.
The trial is part of IMI's New Drugs 4 Bad Bugs (ND4BB) program, which aims to address the challenges of increasing antimicrobial resistance Europe . SAATELLITE is the first clinical trial to test an innovative anti-infective drug outside of antibiotics under the ND4BB and its completion is an important step for the program.
As part of the ND4BB program, the COMBACTE-NET consortium represents the first European public-private partnership set up to promote the clinical development of new medicines in the fight against AMR. The group of experts consisting of members of the consortium specializes in microbiology, critical care, epidemiology, biomarkers or clinical trial management of research organizations, universities, from hospitals and pharmaceutical companies. It is a unique opportunity to improve and accelerate the development of anti-infectives.
COMBACTE-NET aimed to support the clinical development of suvratoxumab (MEDI4893), a human mAb developed by AstraZeneca targeting a toxin produced by Staphylococcus aureus, which is one of the main bacteria often badociated with nosocomial infections and AMR.
The phase 2 study, SAATELLITE, was directed by Bruno François of the University Hospital of Limoges (la France) as co-ordinating principal investigator, and Hasan Jafri AstraZeneca as scientific leader of the sector. This is the first interventional trial designed and implemented within COMBACT-NET. It also represents a potential paradigm shift in the field of infectious diseases, by studying a preventive approach using mAb to prevent VAP and nosocomial pneumonia due to: Staphylococcus aureus in critically ill patients in intensive care. Patients were eligible if they were colonized in the lower respiratory tract with Staphylococcus aureus; determined using a real-time polymerase chain reaction (PCR) test, another innovative approach to the test.
Hasan Jafri, Senior Director of Clinical Research and Development, AstraZeneca, and coordinator of COMBACTE-NET, said: "The SAATELLITE study is an example of extremely successful public-private collaboration, necessary for the development of new medicines to meet the challenges posed by the growth of antimicrobial drug resistance in Europe . As the first and largest preventive trial within the consortium, the new trial design required the development of new endpoints, which distinguishes SAATELLITE from traditional non-inferiority trials. "
Bruno Francois, the coordinating principal investigator at Limoges University Hospital, said: "The SAATELLITE trial clearly demonstrates the extraordinary ability of the COMBACTE-NET consortium to set up and carry out such an innovative trial on a population of patients in France. USI SAATELLITE opened the field of infection prevention based on lessons learned and taking advantage of the different resources of COMBACT, a similar phase II trial using another Pseudomonas aeruginosa in mechanically ventilated patients is currently recruiting within the COMBACTE-MAGNET consortium. "
Pierre Meulien, executive director of IMI, said: "Public-private collaboration is essential to progress in the development of new treatments for resistant infections.The success of the SAATELLITE study is the most important. the culmination of the hard work of scientists from academia and industry, as well as countless clinicians, Europe . I would also like to thank the patients who have agreed to participate in this innovative study. "
The results of SAATELLITE are presented at the ECCMID meeting at Amsterdam sure April 16th and at the ATS meeting at Dallas sure May 20th.
About the SAATELLITE trial
The SAATELLITE trial introduced new concepts in clinical research with a preventive approach and the use of PCR molecular diagnostics to screen patients for eligibility for study. The SAATELLITE study has had a wide and very active participation of all stakeholders, illustrating the public-private partnership. These include: protocol development, including endpoint definitions; develop transparent and predefined criteria for the selection of research centers and clinical research organizations (CROs); and independent academic committees providing scientific oversight, security and operations. COMBACTE-NET networks, such as CLIN-Net and LAB-Net, participated in the selection and training of sites and laboratories. CLIN-Net maintains an updated portfolio of clinical trial sites in Europe . This maximizes the effectiveness of site selection and performance of antimicrobial resistance studies. LAB-Net also coordinated biomarker badyzes in the various specialized university biomarker laboratories Europe . The subjects of the study were reviewed in 48 research hospitals in 9 countries in Europe .
About the IMI ND4BB Program
The European Union, represented by the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), has launched the New Medicines 4 Bad Bugs Program (ND4BB). It is an unprecedented partnership between industry, academia and biotechnology organizations to fight antibiotic resistance worldwide. Europe by tackling the scientific, regulatory and commercial challenges that hinder the development of new antibiotics, thanks to EU funding and innovative drug initiative, and in-kind contributions from the EU. # 39; EFPIA. For more information on COMBACT projects, visit www.combacte.com. For more information on the IMI ND4BB program, go to https://www.imi.europa.eu/projects-results/project-factsheets/nd4bb www.imi.europa.eu and on IMI on www .imi.europa.eu.
About the university hospital of Limoges
The University Hospital of Limoges was created in 1976 with three main missions: patient care, teaching, research and innovation. The CHUL is made up of 5 different hospitals with more than 7,000 professionals and a Clinical Investigation Center certified by Inserm (CIC 1435), which brings together more than 40 people (doctors, chiefs of European projects, research nurses, clinical research badistants, financial managers, medical translators, etc.). The CIC 1435 is dedicated to the promotion and implementation of clinical research inside and outside the Limoges Hospital. In addition to participating in multicentre research projects and providing logistical support to local teams, the CIC focuses its research activities on infectious diseases, including the mechanism of antibiotic resistance, and infectious diseases in critically ill patients. The CIC 1435 provides clinical research expertise and expertise in the field of infectious diseases, particularly sepsis, and is often the highest enrollment in international multi-center sepsis trials. For more information, visit www.chu-limoges.fr
About COMBACT
In November 2011, the European Commission, as part of its plan to tackle the growing threat of antimicrobial resistance, called for "an unprecedented collaborative effort in research and development to bring new antibiotics to patients ", in particular by launching the sixth, eighth and eleventh IMI Calls for proposals May 2012, December 2012 and December 2013 respectively, under the program entitled "New Drugs 4 Bad Bugs (ND4BB)". The ND4BB program includes the COMBACTE-NET, COMBACTE-MAGNET, COMBACTE-CARE and COMBACTE-CDI consortia, which were trained in January 2013 January, March 2015, and November 2017, respectively. The management office of the COMBACTE program is based at the University Medical Center Utrecht, one of the largest public health institutions in the country. the Netherlands.
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