The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) and the American Society for Microbiology (ASM) have just closed a joint conference in Vienna, which aimed to help researchers accelerate the development of new antimicrobials and to shed light on the challenges associated with antimicrobial resistance.
Several key presentations at the conference highlighted important issues in the field of antimicrobials: the optimisation of drug development, strategies to overcome regulatory hurdles, public-private partnerships, innovative trial design, approaches to decrease resistance in new molecules or better access to safe and effective treatment for special populations including children or pregnant women.
Regulation of innovative approaches to tackle resistance
Widespread drug resistance to antibiotics was the central theme of the conference. Dr John H. Rex, Chief Strategy Officer at AstraZeneca, stressed that all future clinical trials need to be designed with antimicrobial resistance in mind. Wild-type bacteria – which are susceptible to most antibiotics – have become rare, while those that developed usual drug resistance (UDR) are more common, Rex explained.
Dr Edward M. Cox, Director at the Office of Antimicrobial Products at the U.S. Food and Drug Administration explored some of the issues that contribute to the lack of antimicrobial in development. Despite progress with some recent approvals, tough scientific and economic hurdles remain, so that most new molecules in phase I clinical trials never make it to phase II, Cox stated.
Women and children don’t come first when it comes to antimicrobials
Antimicrobial drugs behave very differently within the organ systems of a newborn compared to an adult, so clinical trial results cannot be extrapolated. As Prof. John van den Anker (University Children’s Hospital, Basel, Switzerland) explained, it is also difficult to predict how a pregnant woman and her unborn child will react to emergency antimicrobial therapy. Standard clinical trials fail to provide data on drug toxicity and efficacy in pregnant women and children because it is unethical to enrol them in trials.
New positive initiatives emerging
In his presentation, Prof. Mike Sharland (University of London, UK) confirmed the lack of a global consensus on how to conduct clinical trials in children with severe infection, and a paucity of guidance on how to develop and test new antibiotics for use in children and neonates. He did, however, also report that promising studies are now emerging, including strategic trials to re-evaluate older antibiotics for children. He called for new initiatives in Europe and the U.S. to recognise the need for detailed data on newly developed antibiotics and older drugs that have never been tested in this population.
