If the arrival of COVID-19 represented a tragic and profound disruption to every facet of our lives, then 2021 has demonstrated the remarkable progress that can be achieved through global investment in the research and development of diagnostics, vaccines and treatments. At the same time, the appearance of new COVID variants has driven home the urgency of ensuring equitable access to health measures for all people, everywhere. These lessons have made the importance of our mission even more apparent as we’ve pushed forward throughout 2021 with the development of new treatments to tackle the silent pandemic of drug-resistant infections.
GARDP realized several important milestones this year. This includes activating trial sites in South Africa and Thailand and progressing recruitment as part of our global study of zoliflodacin as a new treatment for gonorrhoea, an infection on the rise globally that has progressively developed resistance to available drugs. Under our partnership agreement with US-based biotech, Entasis Therapeutics, we’re responsible for the phase 3 trial and pharmaceutical development activities for zoliflodacin to support regulatory approval and market access. This includes signing an agreement with the Thailand Ministry of Public Health this year to develop an access strategy to ensure zoliflodacin will be available as early as possible in the country.
In July we announced an MOU with the Clinton Health Access Initiative and Japanese pharmaceutical Shionogi & Co., Ltd, to accelerate access, including in low- and middle-income countries, to the antibiotic cefiderocol for bacterial infections in patients with limited treatment options. As we reach year end, our partner Venatorx Pharmaceuticals, supported by GARDP, completed patient recruitment in the pivotal regulatory trial, in complicated urinary tract infections, to confirm the safety and efficacy of cefepime-taniborbactam, an antibiotic also in development for infections for which there are limited options.
We completed one of the largest ever studies on the care of babies with sepsis, a leading cause of death and disability in newborns up to 28 days old. Data from this study has been analysed and will be published in the coming months. We are currently preparing for a trial to develop new and improved treatments for newborns, using a design informed by our observational study.
In parallel we’ve successfully identified three existing antibiotics – fosfomycin, flomoxef and amikacin – as potential alternative treatments to ampicillin-gentamicin, the current WHO recommended treatment for clinically diagnosed sepsis in newborns. We’re also excited to have partnered with German pharmaceutical InfectoPharm to develop improved treatment options, using combinations of existing antibiotics, for neonatal sepsis.
Our REVIVE webinars were joined live by almost 3,000 participants in 108 countries, with many more watching and sharing the recordings. We also launched our new AMR Discussions series, as a forum for important conversations on tackling drug resistance with experts in the field.
Throughout 2021, we have continued to position GARDP as a key global player in the response to drug resistance. This was reflected in the inclusion of GARDP in the G7 Health and Finance Ministers Declarations in June and December, as well as through a high-level panel on the G7 response to antimicrobial resistance organized by GARDP at the UNITE Annual Parliamentarian Summit.
Earlier this year, with the Swiss Federal Council, we signed an agreement relating to the privileged status of GARDP in Switzerland, a recognition of the major role we play in the fight against antibiotic resistance. Only a dozen Swiss international foundations have been granted privileged status by the Swiss government since the entry into force of the Swiss Host State Act in 2008.
We’re also privileged to have received new and renewed funding commitments from the governments of the UK, Japan and Monaco, the South African Medical Research Council and the Canton of Geneva.
Our work this year has only been made possible through our partners, supporters and colleagues. Thank you for your unwavering commitment to the development of lifesaving and lifechanging antibiotics, for all who need them. The GARDP team looks forward to our continued collaborations throughout 2022.
GARDP Executive Director