GARDP treatments and projects.
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Expanding access to cefiderocol
Through a milestone technology transfer agreement between the Japanese biotech Shionogi and Indian manufacturer Orchid Pharma, GARDP aims to expand access to cefiderocol.
As of 2021, cefiderocol is the only recently authorized antibiotic with activity against all Gram-negative bacteria on the WHO critical priority pathogens list. This collaboration will help to expand access to this important drug to 70% of the globe.
Secure
SECURE is a joint initiative between GARDP and WHO aimed at helping countries, particularly LMICs, expand sustainable, equitable, and appropriate access to essential antibiotics – both generic ones that are not widely available and newly approved Reserve treatments that are kept as a last resort for difficult-to-treat drug-resistant infections.
Through supply planning and sharing forecasting and procurement tools with countries, GARDP and WHO aim to improve decision-making and reduce antibiotic shortages.
Debio1453
GARDP is collaborating with Debiopharm on a license agreement to pursue the development of Debio1453, a novel, first-in-class antibiotic targeting Neisseria gonorrhoeae. The partnership aims to ensure that gonorrhoea continues to be treatable by ensuring that the antibiotic pipeline continues to be replenished.
Through the agreement, GARDP has the rights to manufacture and commercialize the drug in more than 160 countries.
Global neonatal sepsis observationalstudy (NeoOBS)
Working with partners, GARDP has conducted one of the largest ever observational studies on over 3,200 newborns across 19 sites in 11 high-, middle- and low-income countries across four continents. The aim was to assess which antibiotics are currently being used for neonatal sepsis, and to what extent resistance makes these treatments ineffective.
The study findings provided a wealth of high-quality data which has helped inform the design of the NeoSep1 trial.
Zoliflodacin
GARDP is developing and commercializing zoliflodacin, a new first-in-class, single-dose, oral antibiotic for multidrug-resistant
Neisseria gonorrhoeae. It is one of the new treatments developed solely for gonorrhoea in decades, and the first to be developed by a non-profit R&D model.
GARDP has the rights to register and commercialize the product in more than three quarters of the world.
BWC0977
GARDP is working with India-based Bugworks Research Inc. to co-develop a novel, broad-spectrum antibiotic BWC0977 and make it accessible in 146 countries.
Currently in phase 1 development, this first-in-class drug candidate has demonstrated broad-spectrum activity in the lab against all critical priority pathogenic bacteria that commonly cause life-threatening SBIs.
Neosep1 Trial
Launched in South Africa and Kenya in early 2023, the NeoSep1 trial is evaluating new combinations of existing antibiotics and comparing them to treatment regimens that are currently used to treat newborn babies with suspected sepsis. It is also looking at the appropriate dose and formulation for newborns.
The innovative trial design of NeoSep1 guarantees success by generating actionable treatment data. The trial will be expanded to other countries in Africa and the Asia-Pacific region with the expected target of enrolling more than 3,000 newborns by end 2028.