2023: A Year in Review

6 December 2023

When any new organization is launched it inevitably must go through an initial start-up and growth phase, and GARDP is no exception. This is necessary to establish whether the seed funding generated can build the components and partnerships needed to get the concept off the ground. So, as 2023 draws to a close, it doesn’t just mark the end of an incredibly eventful year for GARDP, but also the culmination of the five years of hard work needed for us to complete these important phases.

During this period, we have succeeded in building our programmes and our team, expanding from just a few staff members in 2017 to a mature, experienced team today. In the process, I think it is fair to say that we have now firmly established that our model can work, based on critical milestones that we have reached this year, and the level of support and engagement we are now getting. That is reflected in the level of progress we have made towards our goal of developing five new antibiotic treatments by 2025.

In June, a landmark global observational study, led by GARDP and published in PLOS Medicine, found that World Health Organization-recommended antibiotics are becoming less effective at treating hospitalised newborns with sepsis. On the back of this, we launched a groundbreaking clinical trial to evaluate new combinations of three existing antibiotics – flomoxef, amikacin and fosfomycin – as well as other treatments, to treat neonatal sepsis.

By August, our collaboration with Venatorx Pharmaceuticals, Inc. reached the point where the US Food & Drug Administration has now accepted a New Drug Application for cefepime-taniborbactam. If successful, this will become the first new treatment in our portfolio to receive regulatory approval, paving the way for a new treatment for serious bacterial infections for both adults and children.

In September we signed a critical sublicensing agreement with Orchid Pharma Ltd. in India to improve equitable global access to cefiderocol for treating certain Gram-negative infections. Then in November we issued a joint announcement with Innoviva Specialty Therapeutics on the positive phase 3 trial results for zoliflodacin. If approved, this would become the first in a new class of antibiotics and the first new treatment for gonorrhoea in decades.

Individually, each of these milestones represents an important advance in the fight against antimicrobial resistance (AMR) and the treatment of World Health Organization priority pathogens, but collectively they demonstrate that GARDP’s model is working. This is now beginning to get the attention it needs and deserves, with enormous amounts of global coverage generated in the international and pharmaceutical media on the back of our announcements, particularly with cefepime-taniborbactam and zoliflodacin.

What is particularly encouraging is that increasingly this media coverage is reporting not just on the drugs themselves, but on how we developed them. As the threat posed by AMR continues to increase, our innovative public-private partnership model for antibiotic R&D and access is precisely what is needed, and the world is now taking note. This will become increasingly important in the run-up to next year’s High-Level Meeting on AMR at the United Nations General Assembly, and as we move into our next 2024-2028 strategic phase, to generate the €220 million needed to continue our work.

Even before we begin our next fundraising round to reach this target, we have seen promising signs of support. In addition to the £5 million we received earlier in the year from the UK government to improve R&D and access and €8 million from the European Union’s Health Emergency Preparedness & Response Authority (HERA), we have now recently received new support from the RIGHT

Foundation of 4 billion South Korean Won (~€2.8 million) and Japan has renewed its support with US$1.8 million as part of its one billion yen pledge.

2023 also marked the beginning of our renewed collaboration with the German Federal Ministry of Education and Research (BMBF) with an additional funding of EUR 50 million to support our vital work over the next five years (2023-2027). Finally, we have also received as a four-year pledge of CHF 3 million from the Swiss Agency for Development and Cooperation (SDC) to support GARDP’s antibiotic access activities in LMICs.

What we have achieved together over the last five years has been simply remarkable, and I am extremely proud and grateful for the incredibly hard work and dedication of the entire team at GARDP and thanks to the critical support we have received from all our donors and partners. Now that we have laid the foundations, the emphasis with GARDP 2.0 will be to build on this to show how our model can create a stronger ecosystem for antibiotic R&D and access. In doing so, we hope to demonstrate that together with our partners we can address the public health failure at the heart of this global AMR crisis.

Yours sincerely,

Manica Balasegaram

Executive Director, GARDP