2020 was an extremely challenging year for all of us. COVID-19 has brought tragic loss, suffering and disruption to every corner of the world. And it will do so until we finally contain this virus.
We want to begin this report by thanking our partners, supporters and colleagues for their unwavering commitment to GARDP and its vital work against this extraordinary backdrop of adversity. Thanks to their courage and enthusiasm 2020 was a year in which we were able to make remarkable progress despite the many challenges.
In July, following a minimal pandemic-related delay, we locked the database on one of the largest global observational studies on the care of newborns with sepsis. This study, which involved newborns at 19 sites across 11 countries, will provide the evidence we need to fill knowledge gaps, improve treatments and save lives, and inform a clinical trial—slated for a 2022 start—that will evaluate the potential of three antibiotic combinations in treating neonatal sepsis.
Unfortunately, the COVID-19 pandemic has made for an extremely challenging research environment this past year. Our work on a novel antibiotic cefepime-taniborbactam did not escape the effects of this sweeping crisis, with both the initial phase 3 clinical trial and an observational study, investigating resistant infections, being delayed. Nevertheless, crucial preparatory and mitigating steps on both fronts have been undertaken and the partnership is on track to both complete the phase 3 study and start the observational study in 2021. The first clinical trial to develop this antibiotic combination for children will start in 2022. Cefepime-taniborbactam has the potential to address significant unmet need as a new treatment for antibiotic-resistant infections in adults and children, and we will work closely with our partner Venatorx to make it available to everyone who needs it, wherever they live.
In September 2019, GARDP’s Sexually Transmitted Infections programme initiated its phase 3 trial of zoliflodacin, a novel antibiotic to treat gonorrhoea, with the activation of sites in the US. However, as the pandemic unfolded, it became clear we would be required to place the trial on hold. Recruitment in the US was temporarily paused in March, as our focus turned to creating a strategy that would enable us to safely re-launch the study. Thanks to that hard work, we were able to resume patient recruitment in the US and enroll our first patients at sites in The Netherlands.
As the pandemic unfolded, our extensive experience in running virtual events enabled us to quickly and seamlessly move all of our conferences and webinars online. This move did not hinder the ongoing success of our Scientific Affairs programme, whose activities are hosted on the REVIVE website, and promote the retention and sharing of knowledge among the antimicrobial R&D community. We are delighted to have reached over 3,800 people from over 100 countries through 17 webinars last year, with the REVIVE website content accessed by users in 182 countries. Another highlight was our new online Antimicrobial Encyclopaedia, which Scientific Affairs launched last October in time for World Antimicrobial Awareness Week.
If 2020 reminded us of one crucial fact, it is that infectious diseases have no regard for national borders. Ideally, neither should drugs or vaccines. The only way to contain COVID-19 and ensure we are more prepared for future pandemics will be through a coordinated global effort—no country nor sector will succeed by going at it alone. And just as pandemic preparedness has become a priority for countries, so awareness has grown of the need to tackle the silent pandemic of antibiotic resistance.
Recognizing the critical role of antibiotics in pandemic readiness and modern medicine more generally, the German government announced in September that it would provide additional funding of EUR 5 million for GARDP. Also in 2020, Japan made its first contribution of 200 million yen (US$1.8 million) to GARDP, as part of a broader 1 billion yen pledge. Towards the end of year GARDP received an additional GBP 1.5 million from the UK to develop a new treatment for drug-resistant gonorrhoea.
As consciousness of antimicrobial resistance remains high, what we urgently need is more financial investments to tackle this silent pandemic. We are seeking €500 million to develop five new treatments by 2025 for drug-resistant infections that pose the greatest threat to health and ensure their responsible use and sustainable access.
We at GARDP, together with our partners from the public and private sectors, will redouble our efforts to ensure that antibiotic resistance never paralyzes the world as the COVID-19 pandemic has this past year. As we begin to look forward to life beyond this global health crisis, we and the whole team are looking forward to the next chapter of our work in tackling another great health challenge of our time.
The 2020 Activity Report shows GARDP’s progress and promise in the fight against the most serious drug-resistant infections. It also demonstrates why more partnerships and investment are critical to address the growing threat of antibiotic resistance and achieve the Sustainable Development Goals.
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