The European Union’s Innovative Medicines Initiative (IMI) has launched the first two projects under its research programme for antimicrobial resistance, unveiled in May 2012.
Backed up with funding of €223.9 million in total, the projects launched under the New Drugs for Bad Bugs (ND4BB) programme “are set to revitalise antibiotic development by promoting greater collaboration within the entire antibiotic development community, and by tackling key challenges to the development of new medicines”, the IMI said.
The ND4BB initiative is part of the European Commission’s Action Plan Against the Rising Threats from Antimicrobial Resistance (introduced in November 2011) and has featured in two IMI Calls for proposals since its launch.
As the IMI points out, antimicrobial resistance (AMR) is responsible for some 25 000 deaths in the EU every year, while annual treatment and social costs have been estimated at around €1.5 billion.
6th Call
The two ND4BB projects announced yesterday come out of IMI’s 6th Call for research proposals, launched in May 2012. They are COMBACTE (Combating Bacterial Resistance in Europe) and TRANSLOCATION (Molecular basis of the bacterial cell wall permeability).
The €194.6 million COMBACTE project aims at a comprehensive clinical-research agenda to address antibacterial resistance, driven by a new collaborative model combining the knowledge and expertise of academic investigators and industry researchers.
A key objective is a pan-European clinical-trial network to recruit patients for, and conduct efficiently, high-quality multinational trials at all stages of development.
The project, which includes input from GlaxoSmithKline, AstraZeneca and Janssen Infectious Diseases – Diagnostics, as well as from smaller Dutch company Julius Clinical Research, will also set up a pan-European laboratory network to deliver epidemiological information and data from microbial surveillance work that can inform the selection of clinical-trial sites.
Trial designs
The COMBACTE team plans to develop innovative trial designs that will facilitate the registration of novel antibacterial agents. It will also design and validate tests to support patient diagnoses, identify the most appropriate treatments and monitor patient responses.
These novel clinical-trial designs will be tested on drugs under development by the pharmaceutical companies involved in the project, starting with “a novel antibiotic that appears to be effective in respiratory and skin infections caused by multi-drug resistant pathogens such as methicillin-resistant Staphylococcus aureus (MRSA)”, the IMI noted.
TRANSLOCATION
GlaxoSmithKline, AstraZeneca and Janssen are all member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which supports IMI projects on a 50:50 funding basis as a public-private partnership with the European Union.
These three companies are also participating in the €29.3 million TRANSLOCATION project, along with EFPIA members Basilea Pharmaceutica and Sanofi, and Bruker Daltonik, a non-EFPIA company from Germany.
TRANSLOCATION will investigate new pathways for getting antibiotics into bacteria and preventing bacteria from expelling the drugs before they can take effect. It will work primarily on Gram-negative pathogens such as Escherichia coli and Klebsiella pneumoniae.
Ideal platform
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 treat resistant infections”, IMI stated. Efforts to develop novel antibiotics are hampered by “a number of scientific and regulatory hurdles that cannot be tackled by any individual organisation working alone”.
To avoid a public health emergency, “the entire antibiotic research community must work together to reinvigorate research into new antibiotics,” it added. “As a public-private partnership (PPP), IMI is the ideal platform to launch such an initiative.”
In its Action Plan Against the Rising Threats from Antimicrobial Resistance, the European Commission called for “unprecedented collaborative research and development efforts to bring new antibiotics to patients”, including the launch of an IMI programme “for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge”.
Pioneering model
EFPIA said it “strongly supports” the two ND4BB projects, “not only for the invaluable research that they will bring to patients throughout the EU but also for the pioneering collaborative model that they represent”.
As a public-private partnership, COMBACTE “challenges the normal way in which academics and the industry interact, pushing aside the fee for service model”, the Federation noted.
The collaborative approach “recognises that the development of much needed antibiotics is the responsibility of both public and private partners and is no longer a wholly commercial endeavour”, it commented.
All data (positive and negative) from the project will be published in peer-reviewed journals, while COMBACTE investigators and the wider scientific community will have the opportunity to access patient-level data from the studies after publication, EFPIA added.
