COVID vaccine trials were a triumph, so let’s start again for antibiotics
The triumph of the development of the COVID-19 vaccine and the discovery of effective treatments has only been possible thanks to the unprecedented coordination of clinical trials. A testing process, which often lasts over a decade, was compressed into less than nine months. This should now be the model for other major global health crises, namely antimicrobial resistance (AMR).
To stay ahead of the curve and respond quickly to non-viral microbial threats, we believe it’s time to build a new, forward-looking clinical trial infrastructure. A network of public clinical trial institutes could permanently link preclinical academic ingenuity to the best of post-clinical business knowledge and replenish the empty pipeline of new antibiotics. It is urgent to take action. This is the conclusion of a study we conducted with Adam Roberts, from the Liverpool School of Tropical Medicine, and Andrew Singer, from the UK Center for Ecology and Hydrology, which we recently published on the SocArvix server.
AMR, the natural process by which bacteria adapt to resist antibiotics used to control them, poses a serious threat to global health and food production systems. Tens of thousands of people are already dying and many more are suffering from infections that were once treatable, and the problem is quickly getting worse.
Part of the solution lies in better management of the antibiotics we already have. Each time an antibiotic is used, it creates an evolutionary advantage for bacteria that can resist its effects. Over time, this leads to a resistant bacterial population. Antibiotics are therefore a time-limited resource that should be used sparingly.
The bacteria have developed resistance to all antibiotics ever developed. For example, it took just six years for resistance to penicillin, the first antibiotic, to spread in UK hospitals.
The other part of the solution lies in stimulating the antibiotic research and development pipeline for new antibiotics.
But there are well-known economic barriers to commercial antibiotic research and development. Most importantly, researching, testing and approving new drugs is expensive, but new antibiotics pay less than cancer or chronic disease drugs and must be protected from overuse to prevent resistance.
There is also no guarantee that investing in a promising compound discovered during preclinical research will result in a viable drug. Currently, about 95% of promising preclinical compounds that enter human trials do not pass through the “valley of death” of clinical trials until regulatory approval.
This is because some compounds show little or no effect, others have side effects, and some developers are unable to attract and maintain the levels of investment needed to fund expensive clinical trials, which can take more than 13 years. Many other research projects fail before they’ve even been tested on humans.
Faced with so many risks and less attractive prospects for profitability than with other drugs, why would a commercial developer invest in research on antibiotics?
To attract commercial investors to the fold, Britain, the United States and the EU have invested more than US $ 1.5 billion in public money to subsidize early-stage research and increase financial returns antibiotics that pass tests.
At the recent G7 meeting, the UK tried to promote an antibiotic subscription model, which it had implemented in 2020. Like Netflix, governments would no longer pay the industry by antibiotic pill used (as they do now) but for the value of this pill to society. It is hoped that guaranteed profits and minimized investment risks will encourage large pharmaceutical companies to reinvest in research and development.
So far, the success of traditional market-based grants has been limited and G7 members have not made an explicit commitment to the UK subscription model. Although they have agreed to further explore strengthening market incentives.
Learn from COVID-19
With a global wave of antimicrobial resistant organisms already upon us and COVID-19 putting additional pressure on existing antibiotics due to concomitant and secondary infections, we urgently need new, creative approaches to fill the pipeline.
One solution may be to reverse the existing subsidy model for new antibiotics. Rather than putting all the eggs in one basket and funding individual businesses with drugs that may or may not cross the Valley of Death, we are proposing to build a bridge across this valley with a network of public institutes. These institutes would be able to conduct clinical trials and produce limited quantities of experimental antibiotics. They could basically fix the broken pipeline.
An infrastructure dedicated to clinical trials of antibiotics would combine the best of know-how from the public and private sectors. Intellectual property resulting from public research would remain in the hands of the public, and academics could take full credit for their findings by publishing the results rather than waiting for patent applications to be filed.
In addition to protecting compounds from commercial failures and disappearing behind patent barriers, a permanent network of clinical trial institutes could also reduce the cost and increase the quality of trials.
Right now, developers have to attract large amounts of venture capital to fund commercial trials. Dedicated institutes for antibiotic testing would reduce the risks of this process, strengthen human expertise in drug testing, and significantly reduce research and development costs for public and private developers.
By making access to public trial networks dependent on the targeting of priority pathogens identified by the World Health Organization, preclinical research and development would be encouraged to target the most urgent health problems and not just the most profitable. Meanwhile, clinical trials could take place in low-income areas where new antibiotics are most needed.
At the end of a clinical trial, industry could be commissioned to do what it does best: manufacture and distribute. Like other public services provided by for-profit companies, new drugs could be distributed by commercial manufacturers able to ensure environmentally friendly production and affordable drug prices.
Long-term supply contracts for healthcare providers and a reorientation of existing antibiotic subscription models in the UK and Sweden could easily be used to incentivize manufacturers to bid and ensure commercially viable production of new drugs.
The global COVID vaccine response has revealed the importance of forward-looking public infrastructure and research investments to stay ahead and respond quickly to microbial threats.
A network of public clinical trial institutes for antibiotics could do just that and benefit both public and commercial developers in the process. After more than 30 years of innovation blockades and stop-start grants, this could definitely close the testing gap.
New Antibiotic to Fight Deadly Bacterial “Superbugs” Enters Clinical Trials
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