For at least a decade, the global scientific community has been warning of a pending crisis caused by growing microbial resistance to antibiotics. Some action has been taken, notably a more stringent approach to hygiene in hospitals and changes to prescribing practices by doctors, but to date the pharmaceutical industry has shown little inclination to put its considerable resources towards averting a potential disaster. However, there are now signs that an increase in incentives to encourage the development of new antibiotics may at last be bearing fruit.
Members of the BEAM Alliance – 40 biopharma SMEs from 11 European countries – are developing around a hundred new compounds to treat or prevent bacterial infection; 20 of these are currently in clinical development and could bring hope to patients with multi-resistant infections.
The Alliance is urging the creation of a dedicated fund to encourage biopharma SMEs to develop innovative antibacterial products, together with greater market incentives and an accelerated, simplified regulatory pathway for products tackling microbial resistance.
Bacteriophages are a promising approach to fighting resistant organisms but have been largely overlooked because they currently lie outside the EU’s regulatory framework. In spite of calls for this to change, there is little sign of anything happening in the foreseeable future, despite reports of favourable outcomes in patients for whom this is the treatment of last resort.
The European Medicines Agency is, however, taking steps to facilitate and speed up the development of new antibiotics with a draft guideline on the use of pharmacokinetics and pharmacodynamics analyses, which it says can reduce the size of the clinical development programme.
But these are only opening skirmishes in the war against antibiotic resistance. Battle lines will need to be drawn soon and forces gathered before the enemy becomes insurmountable.
