AstraZeneca and GlaxoSmithKlinehas welcomed the launch of a pioneering approach to antibiotic research in Europe that will see pharmaceutical and biotechnology companies working alongside public partners to tackle the rising threat from antibiotic resistance and address some of the key barriers to the development of effective antibiotics.
The objective of the proposed research program is to improve the underlying scientific understanding of antibiotic resistance, design and implement efficient clinical trials and take novel drug candidates through clinical development. The program is part of the European Commission's “Action Plan Against the Rising Threats from Antimicrobial Resistance,” launched in November 2011.
Set against a backdrop of emerging resistant bacteria and with the pipeline of future antibiotics described by the World Health Organization (WHO) as "virtually dry," this innovative research program, NewDrugs4BadBugs, intends to boost the currently faltering discovery and development of new antibiotics.
Supported by the Innovative Medicines Initiative (IMI), Europe's largest public-private initiative, the research programme's first projects will be funded by a joint budget of up to $280 million: $136 million provided by IMI, and $144 million in-kind contributions from the pharmaceutical and biotechnology companies involved. GlaxoSmithKline, AstraZeneca, Janssen, Sanofi and Basilea Pharmaceutica will work alongside public research organizations and scientific experts to address several aspects of resistance and stimulate new antibiotic research. Further projects within the program, with additional funding, are expected to launch later this year.
Antibiotic resistance is increasingly becoming a worldwide health threat. Many of the medical advances in recent years, such as chemotherapy for cancer treatment and organ transplantation, depend on effective antibiotics. Despite this need and the continued emergence of bacteria resistant to existing drugs, research has diminished over the past 15 years and few companies remain active in this area. This is due to the scientific difficulties in finding new agents that successfully target bacteria, regulatory complexities and a lack of the commercial incentives needed to encourage investment in this area and to fund future R&D.
"The steady rise of drug-resistant bacteria is an imminent and urgent threat to public health, and without a reliable arsenal of effective antibiotics, modern medical care is not possible,”said Martin Mackay, president of R&D, AstraZeneca. “Bacteria develop resistance as fast, or faster, than we can develop treatments and a combination of scientific, regulatory, and financial challenges have impeded new antibiotic development.”
McKay continued, "It is time to tackle this issue in a different way, sharing information and expertise among public and private partners – collaboration of this type is critical if we are to speed up the discovery of these medicines to improve patient health."
The proposed research program will initially focus on three key areas: progressing development of pipeline antibiotics, information sharing and continuing research and discovering new antibiotics.
The funding will support new research that will progress potential antibiotics already under investigation through clinical trials and improve the design of future clinical trials. GSK's investigational antibiotic, GSK1322322, targeting multi-drug resistant respiratory and skin infections including MRSA (methicillin resistant Staphylococcus aureus) and currently in phase II development, will be included in the research program. Pending the results of ongoing work, these will be joined slightly later by AstraZeneca's MEDI4893, a novel investigational monoclonal antibody in early stage development that targets a toxin released by Staphylococcus aureus and AZD9773, an investigational treatment for severe sepsis and septic shock, conditions triggered by uncontrolled bacterial infection.
The collaboration will be underpinned by an unprecedented level of data and knowledge sharing. It is hoped that developing a platform to enable the sharing of knowledge and resources across multiple groups will improve the chances of success in developing the next generation of antibiotics. A new information hub will allow the sharing of knowledge and data between participants and across the wider antibiotic research community to enable the field to learn from antibiotic development successes and failures and gain a shared and improved understanding of the science behind antibiotic resistance. This will minimize duplication of effort and reduce inefficiencies in future R&D, supporting antibiotic research through the life of the program and beyond. Participants will share information on the design of clinical trials and the data generated, to support development of novel trials in the future that will increase efficiency of antibiotic research. A clinical trial network will be established to evaluate antibiotics currently in development, enabling experts in clinical antibiotic research to work alongside the scientists developing future medicines.
Furthermore, the program will promote continuing research. Tackling infections caused by Gram-negative bacteria is a very difficult challenge, owing to the particular defence mechanisms they employ. There are few treatment options available and currently limited ongoing development activities in this area. This research program aims to find more approaches to the design of antibiotics that could be effective against Gram-negative bacteria, increase understanding of their defence mechanisms and use this knowledge to support future drug discovery efforts.
Key to the success of NewDrugs4BadBugs will be the involvement of multiple public partners from across Europe. Public institutions and research organizations, clinical investigators and scientific experts are being encouraged to learn more about the proposed research program through a series of events.