A New Start to Anti-Infective Research?


Applied Clinical Trials

Declines in the arsenal of effective antibiotics have been widely recorded and widely lamented for years now, as reduced research investment has conspired with rising antimicrobial resistance to deplete the resources available to doctors faced with cases of serious infection. The cost of AMR is estimated at close to $2 billion per year in Europe—but only two new classes of antibiotics have been brought to market in the last 30 years, and many drug developers have left the field.

This month, a new start is being made on filling some of the gaps. The European Innovative Medicines Initiative is putting up more than $100 million in new money to stimulate investigation.

IMI launched its initial call for proposals on May 24. Focused on combating antimicrobial resistance, with the catchy title of NewDrugs4BadBugs (ND4BB), the exercise aims to combat what is generally acknowledged as a major public health threat. One topic for which grants are being offered is "innovative trial design and clinical drug development." Another topic is "learning from success and failure and getting drugs into bad bugs."

As with all IMI projects, the aim is to bring together the strengths of public and private partners. The objective is to share information and to boost research on improving the uptake (and decreasing the efflux) of antibiotics into Gram-negative bacteria. ND4BB will also develop a data repository as a continuing information base for research projects focused on antibiotic resistance. All project participants will be expected to deposit data in the ND4BB data hub and work together to share data and experience as widely as possible amongst all program members and the antibiotic community as a whole.

The work, for which the indicative time-scale is five to seven years, keys into a broader strategy launched earlier this year by the European Union itself on antimicrobial resistance, and additional calls for proposals addressing further antimicrobial resistance research topics are scheduled to follow throughout 2012 and 2013.

It is a timely bid to address the Catch 22 situation that product development in this field has fallen victim to. Development of antibiotics for the treatment of resistant infections is not a financially viable option for drug developers. The potential low level of use of some antibiotics prevents companies recouping their costs, as they are effectively generating drugs that will only be used under limited circumstances. As IMI points out, the size and cost of an antibacterial clinical trial is dictated by the need to enrol enough patients to ensure a meaningful number of patients with resistant infections are encompassed in the trial. As enrolment must often be on an empirical basis, this dictates large trials which significantly drive up the overall development costs for new antibiotics targeting resistant pathogens. Coupled with the obligation for equivalence studies to be designed to target a 10% delta for the lower limit of the confidence interval, the cost and practicalities of running such studies is cutting back the number of antibiotics currently under development. Without intervention, argues IMI, even fewer companies will remain focusing on AMR.

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