We live in a world in which nearly 1.3 million people die every year to antibiotic resistance, more than HIV and malaria deaths combined. One in five of those who die is a child under 5 years old. These statistics were among the key findings of a ground-breaking study on antibiotic resistance that was published in early 2022. The so-called “silent pandemic” of drug-resistant infections was silent no more. 

It is against this backdrop that GARDP carried out its work in 2022. As part of our contribution to children’s antibiotics, GARDP and partners announced results from a major global study of neonatal sepsis at 19 hospitals in 11 countries of various income levels across four continents from 2018 to 2020. The study found that doctors administered the current WHO-recommended treatment (ampicillin and gentamicin) in a mere 13% of cases and that treatments for neonatal sepsis varied widely, at least in part in response to growing resistance. GARDP is now gearing up to identify alternative, improved treatments for neonatal sepsis in a trial that will start in the coming weeks. 

GARDP also had a breakthrough in its work on serious bacterial infections. GARDP welcomed positive results in the Venatorx Pharmaceuticals clinical phase 3 trial of a new antibiotic combination, cefepime-taniborbactam, to treat complicated urinary tract infections, including those caused by two WHO priority pathogens. Under a collaboration agreement with Venatorx, GARDP has initiated in parallel the paediatric development of cefepime-taniborbactam. If approved by the US Food and Drug Administration in the coming years, cefepime-taniborbactam will be among the first new antibiotic treatments to be launched in collaboration with GARDP since its creation. 

GARDP’s work on sexually transmitted infections has continued to move forward in a global phase 3 trial of zoliflodacin, a novel oral treatment for gonorrhoea. All 16 trial sites have been activated—5 in the US, 1 in the Netherlands, 1 in Belgium, 6 in South Africa, and 3 in Thailand—and nearly all patients have been recruited. With the development of zoliflodacin, GARDP and its development partner Entasis Therapeutics aim to contribute to expanded treatment options for gonorrhoea around the world.     

In the arena of antibiotic access, GARDP and Shionogi & Co., Ltd, made history with the first license agreement for an antibiotic to treat serious bacterial infections between a not-for-profit organization driven by public health priorities and a pharmaceutical company. It is accompanied by a collaboration agreement between Shionogi, GARDP, and the Clinton Health Access Initiative (CHAI). The agreements make it possible for GARDP to help expand access to the antibiotic cefiderocol in nearly 70% of countries worldwide. Currently, GARDP and CHAI are working together to identify a manufacturer/sub-licensee for cefiderocol, which they will announce next year.  

In addition to these highlights, GARDP launched a new observational study of antibiotic-resistant infections in South Africa and India, with results expected next year. GARDP also began to collaborate with Bugworks Research Inc. in India on a phase 1 study, and it signed a memorandum of understanding with Japan’s National Center for Global Health and Medicine (NCGM). Moreover, as part of GARDP’s discovery and exploratory programme, GARDP signed agreements with major Japanese companies, Sumitomo Pharma and Mitsubishi Tanabe Pharma Corporation, to screen their proprietary compounds for activity against target pathogens in search of new antibiotics. GARDP also co-organized the 3rd annual British Antimicrobial Chemotherapy Conference, drawing attendees from 67 countries. Throughout it all, GARDP’s REVIVE platform played a leading role in bringing together the antimicrobial community by producing freely accessible first-rate webinars and articles that feature experts in the field.  

This year’s progress has been made possible by GARDP’s supporters. Germany, the UK, Japan, Australia and Monaco made new and renewed funding commitments to GARDP, and Canada and the Wellcome Trust gave seed funding for the development of SECURE: The Antibiotic Facility. More generally, the G7 under Germany’s leadership made antimicrobial resistance (AMR) an important part of their agenda, and the G20 health ministers published a call to action on AMR.  

There is no doubt: the pandemic of drug-resistant infections is a threat to us all. Nonetheless, the progress by GARDP and others in this field gives me hope that we can address antibiotic resistance together to make a difference for people all over the world. With the entire team at GARDP, I am deeply grateful for your support over the past year as we strive towards a world in which all infections are treatable for everyone, everywhere.  

 Sincerely,  

Manica Balasegaram 

Executive Director, GARDP