The arrival of COVID-19 has brought profound and often tragic disruptions to every facet of life.
In 2021, we have nonetheless witnessed more of the astounding achievements that can be made through global investment into the research and development of diagnostics, vaccines, and treatments. We have also realised that, in the absence of equitable access to these tools, the SARS-CoV-2 virus continues to propagate and mutate, rendering all of us vulnerable.
The issue of inequitable access to new health technologies to address COVID-19 has highlighted the importance of our mission to accelerate the development and access of treatments for drug-resistant infections. A recent study in The Lancet highlighted the nearly 1.3 million deaths that occurred in 2019 due to antimicrobial resistance—more than malaria and HIV/AIDS—and made the case for greater access to effective antibiotics for all people. The importance of GARDP’s mission could not be more evident.
Ramanan Laxminarayan (GARDP board chair) and Manica Balasegaram (GARDP Executive Director)
deliver access for all
Deliver Access for All
In our sexually transmitted infections programme, we continued to collaborate with Entasis Therapeutics on the development of a new drug, zoliflodacin, to treat gonorrhoea.
In 2021, we activated two new countries (South Africa and Thailand) in our pivotal phase 3 trial and finished the year with significant recovery in patient recruitment following the initial impact of the pandemic. GARDP also signed a memorandum of understanding (MOU) with the Thailand Ministry of Public Health to improve treatment for gonorrhoea in the country by exploring timely access to newly developed antibiotics like zoliflodacin.
We made significant progress in our efforts to address serious bacterial infections, which are among the major causes of disability and death for people in healthcare settings. At the end of 2021, through our collaboration with the biotech Venatorx Pharmaceuticals, patient recruitment for the phase 3 trial of cefepime-taniborbactam was completed. This novel antibiotic is designed to treat infections that are resistant to second- and third-line carbapenem antibiotics. Separately, in July, we announced an MOU with the Clinton Health Access Initiative (CHAI) and Japanese pharmaceutical Shionogi & Co., Ltd. The MOU is designed to work toward affordable, sustainable access to cefiderocol, an antibiotic that is included on the World Health Organization’s (WHO) Model List of Essential Medicines, and that is effective against several pathogens included on the WHO Priority Pathogens List.
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“We are working to ensure that new and existing antibiotic treatments like zoliflodacin and cefiderocol are affordable and available globally, particularly in low- and middle-income countries (LMICs), which shoulder a greater burden of drug resistance.”
Our children’s antibiotics programme reached a critical milestone: we completed one of the largest observational studies on the care of babies with sepsis, one of the leading causes of death and disability in newborns up to 28 days old. The results of this ambitious study are forthcoming. In addition, we identified three existing antibiotics (fosfomycin, flomoxef, and amikacin) that have the potential to be used to treat babies with sepsis. Informed by our observational study, we have designed a global public health trial to rank the safety and efficacy of new combinations of these antibiotics against existing antibiotic treatments (including the current WHO-recommended treatment, ampicillin–gentamicin) for the treatment of sepsis in newborns. The trial will also consider how these combinations can best be used in hospital settings with varying levels of antibiotic resistance. Moreover, we are exploring partnerships to support access to these treatments, including with German pharmaceutical company InfectoPharm for fosfomycin.
The issue of access is integral to all of our research and development programmes. We are working to ensure that new and existing antibiotic treatments like zoliflodacin and cefiderocol are affordable and available globally, particularly in low- and middle-income countries (LMICs), which shoulder a greater burden of drug resistance.
In our Discovery & Exploratory Research (DER) programme, we completed work on three chemical series derived from novel chemical entity hits obtained in our high throughput screening.
We have been able to drive the conversation around the challenges and opportunities related to antimicrobial resistance (AMR) through our Scientific Affairs programme. In 2021, we saw substantial growth of the Antimicrobial Encyclopaedia, worked with the British Society for Antimicrobial Chemotherapy (BSAC) and three German guest organizations to host the virtual Antimicrobial Chemotherapy Conference (ACC) 2021, increased the geographic reach of our webinars (which, altogether, saw nearly 3,000 participants from 108 countries join 13 events), and launched the AMR Discussion series. The REVIVE webinars aim to preserve and share knowledge among the scientific community working on AMR, while the newly launched AMR Discussions webinars are a platform for experts in the field to share ideas on how to tackle drug resistance.
GARDP also played a role in increasing political engagement to counter antibiotic resistance. Declarations by the G7 Health and Finance Ministers in June and December drew attention to the issue of AMR and cited GARDP’s role to “support the development and approval of much-needed innovative antimicrobial therapeutics”. In addition, as part of the UNITE Annual Parliamentarian Summit in December, GARDP organized a high-level panel on the role of G7 leadership in accelerating the AMR response.
In 2021, we were honoured to have been granted a privileged status by the Swiss Federal Council, which recognises the major role we play in the fight against antibiotic resistance. We are one of a few international foundations that have been granted such status since the Swiss Host State Act took effect in 2008.
Alongside the long-term ongoing commitments of key funders such as Germany and the Netherlands, we are incredibly grateful for new and renewed funding commitments from the governments of Australia, Japan, Monaco, Switzerland and the UK, as well as from the South African Medical Research Council and the Canton of Geneva. By the end of 2021, GARDP had invested over €75 million since our inception in developing and making accessible antibiotic treatments. The ongoing support of our funding partners is critical to building on these investments.
COVID-19 has taught us that we must do everything we can to avoid another pandemic that disrupts entire economies, societies and health systems. We remain fully committed to addressing antibiotic resistance, a growing health emergency. Together with our partners, GARDP is rising to meet this great health challenge of our time.
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“The COVID-19 pandemic has taught us that we must do everything we can to avoid another pandemic that disrupts entire economies, societies and health systems. We remain fully committed to addressing antibiotic resistance, a growing health emergency. Together with our partners, GARDP is rising to meet this great health challenge of our time.”
Interview
MANICA BALASEGARAM: BUILDING ON 5 YEARS OF IMPACT
Why was 2021 a success?
Last year was a very important one for GARDP. We continued to deliver on our portfolio projects, including a pivotal stage of our phase 3 trial of zoliflodacin, a new treatment for gonorrhoea. We supported our partner Venatorx with its regulatory trial of cefepime–taniborbactam for complicated urinary tract infections. We also enhanced our knowledge-sharing efforts through REVIVE’s online platform. Given that we did all of this while mitigating the ongoing impact of the COVID-19 pandemic and maintaining a strong focus on antibiotic resistance, I believe we ended the year with a stronger team.
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"I think we are now in a great position to focus on three key things. The first is continuing to develop, and potentially expand, our portfolio of antibiotics.
Second, we will do much more in-depth work on access, which is a critical component of our social mission. And third, we will deliver these expansions of GARDP’s mission by securing the necessary resources."
How will GARDP build on the past five years of impact?
I think we are now in a great position to focus on three key things. The first is continuing to develop, and potentially expand, our portfolio of antibiotics. Second, we will do much more in-depth work on access, which is a critical component of our social mission. And third, we will deliver these expansions of GARDP’s mission by securing the necessary resources. This is vital considering, on the one hand, that many countries are now much more focused on long-term pandemic preparedness beyond COVID-19, and, on the other, the most recent data on antibiotic resistance. There is a significant and increasing burden of disease from drug resistance that is currently projected to cause around 1.3 million deaths—a number that is sure to keep rising. Taking on these challenges will require a significant focus on obtaining new and renewed funding, as well as on developing existing partnerships and forging new ones. As such, 2022 will be a pivotal year as we look to build the foundations we need for the work to come.
Why is access central to GARDP’s work?
Access is a very complicated issue, and the COVID-19 crisis has highlighted the many challenges in this area. In short, we cannot just deliver innovation and expect things to fall into place, and we have to learn that lesson—especially when it comes to public health challenges as complex as antibiotic resistance. We have to focus far more on access if we are to deliver on our mission, not least because there are very few other actors already doing so. As our portfolio continues to mature and expand, access will only become more important to maximizing the impact of the products we bring to market.
SECURE will be a key part of our access strategy going forward. Although the initiative will incorporate many proven pathways to delivering access, SECURE is highly innovative in the sense that we will be combining them into a framework specifically developed for the problem we are trying to solve.
How will you capitalize on GARDP’s unique collaborative model to face the new challenges ahead?
I think there is a growing appetite to look at new cooperative models that involve a range of sectors and countries. What we have to work on now is getting the political and financial support we need, working directly with key partners and countries, developing new collaborative models and pilots, and implementing demonstrable pathways. All of that will take time, but we have already begun by using our existing individual projects as pathfinders, as we are doing with cefiderocol (see ‘Access for all’).
One particular challenge is the fact that overall financing for antimicrobial resistance (AMR) is inadequate and, in R&D, funding is currently geared more toward early-stage development. While I think that is probably a good thing during this initial period, we need to begin shifting the focus and significantly enhancing financing towards late-stage development and access. Fortunately, given the institutional experience and expertise that GARDP has built over the last five years, I think we are in a good position to begin working with a range of partners to play a key role in covering this critical gap.
