It’s been four decades since we’ve had a new class of antibiotics. Yet across the world, the number of people suffering from drug-resistant infections continues to rise at an alarming rate.
The world desperately needs new antibiotics – they are the foundation of modern medicine.
Without new antibiotics, infections like blood poisoning, gonorrhoea and urinary tract infections risk becoming untreatable. More people will suffer fatal complications from routine medical procedures like chemotherapy or organ transplants.
But the prospects for new treatments being available to patients are more fragile than ever.
As I described in a commentary in The Times(opens in a new tab), this past couple of weeks has seen a surge in reports on the issue.
The World Health Organization warned(opens in a new tab) that there are too few drugs in the pipeline to deal with the growing threat of drug resistance. Analysis of the early stages of the antibiotic pipeline published in Nature Reviews(opens in a new tab) sees encouraging signs for the pipeline's future resurgence, but warns about its weakness.
The AMR Industry Alliance(opens in a new tab) revealed an overall huge decline in the investment and research of new antibiotics. And most recently, the second Antimicrobial Resistance Benchmark report(opens in a new tab) showed that while a core group of companies are taking promising steps, we are reaching a tipping point. Future success hangs by a thread.
How have we reached this point?
Four years ago, things were looking up. At the 2016 World Economic Forum, around 100 companies and 15 industry associations pledged to reduce the acceleration of antimicrobial resistance, invest in the research and development of new treatments and diagnostics, and improve access to current and new antibiotics.
This marked a promising step for one of the most urgent global health threats of our times. But the broken global market for antibiotics – and the failure of governments to give it the overhaul it badly needs – have meant that many big pharmaceutical companies have either left the field or disinvested.
This has put even more strain on the increasingly fragile antibiotic research and development (R&D) pipeline. Only a handful of large research-based companies remain engaged in developing new antibiotics, with smaller companies facing an increasingly unsustainable operating environment.
Investment from industry is essential to the antibiotic pipeline. While philanthropic and public funders like Wellcome increasingly underwrite high-risk early-stage R&D in antibiotics, we depend on private investors and big pharma to fund the later-stage research and commercialisation.
The 2016 Review on Antimicrobial Resistance(opens in a new tab), commissioned by the UK Government and Wellcome, highlighted the need for new models that can provide more predictable financial incentives. Since then, progress has been meagre. Despite some tentative steps in the UK and the US, and warm words from the G7 and G20, no country has yet made fundamental changes to the way antibiotics are valued and reimbursed.
The burden is falling on small biotechs who have early-stage funding but face an almost impossible path ahead in the later stages of development.
In the best-case scenario, the first two to five products from a pipeline of over 250 would become available in around 10 years. These promising biotechs should not be left facing bankruptcy when they have completed the marathon of research and development to get a new drug approved. Just last month we saw the latest such example with the collapse of Melinta Therapeutics. The sobering reality is that more will follow unless we urgently accelerate action to improve the commercial environment.
We can’t wait any longer. Industry and governments must recognise their shared interest in getting new antibiotics to the patients who need them the most.
If more antibiotics makers go bust, the biggest losers will not be investors, but the patients.