Serious bacterial infections.
The toll of serious bacterial infections.
Serious bacterial infections (SBIs) are a leading cause of death for people in hospitals and other healthcare settings in both high-income countries and low- and middle-income countries (LMICs). Without effective and timely treatment, SBIs can rapidly escalate to cause severe illness and potentially life-threatening complications such as organ failure or sepsis. Such infections are becoming increasingly difficult to treat because of the rise and spread of drug-resistant pathogens.
Research suggests that this global antimicrobial resistance (AMR) crisis has now reached a critical tipping point, with AMR mortality now expected to rise sharply, increasing by 70% by 2050. One of the reasons for this sudden increase is the proliferation of difficult-to-treat, multidrug-resistant Gram-negative infections. With treatment options for such infections becoming ever scarce, multidrug-resistant Gram-negative infections are now expected to make up an increasing proportion of AMR-related deaths in the coming decades.
Deaths linked to SBIs in 2019 – 13.6% of all global deaths.
Deaths worldwide associated with sepsis, and nearly 60% of these were associated with an SBI.
People with SBIs caused by carbapenem-resistant bacteria received the right treatment in some countries, due to a lack of access to antibiotics.
Gram-negative infections are outpacing antibiotic development.
Despite the enormous public health threat posed by SBIs, the world has too few innovative antibiotics in the pipeline and too little access to the ones that still work. As a result, SBIs, especially those caused by difficult-to-treat Gram-negative bacteria, are spreading faster than our pace of innovation. In most of the world, optimal treatments for carbapenem-resistant Acinetobacter baumannii and Klebsiella pneumoniae – Gram-negative bacteria that cause severe lung, urinary, wound and bloodstream infections, especially in vulnerable patients – are not yet available.
Bacteria have the ability to move easily between people and surfaces, and to form biofilms on hospital equipment like ventilators and catheters, allowing them to become entrenched in healthcare settings. Gram-negative bacteria in particular are among the hardest infections to treat and the most challenging to develop new antibiotics for, because their biological structure provides them with additional defences.
There is an unmet need to develop new antibiotics that target these Gram-negative bacteria, and ensure they reach the people who need them. More than 11 million deaths could be prevented by 2050, through the development of innovative new Gram-negative antibiotics, and a further 50 million, by improving access to essential antibiotics more broadly.
Severe bacterial infections can escalate into life-threatening sepsis, a major global killer responsible for one in five of all deaths. Drug resistance increases the risk of treatment failure and rapid progression to sepsis and septic shock, with resistant cases linked to higher hospital mortality.
This highlights the urgent need for timely, effective antibiotics to prevent sepsis and manage it when it occurs, especially in children, who make up roughly half of all sepsis cases.
Tackling SBIs by closing the innovation and access gap.
GARDP is helping to address serious bacterial infections in two ways:
- By accelerating the development of innovative new antibiotics that target the most harmful multidrug-resistant Gram-negative bacteria.
- By expanding access to new and existing antibiotics that are effective against SBIs, including those that can lead to sepsis in adults and children.
GARDP’s selection criteria focus on drugs – in development or existing antibiotics – that have public health value, i.e. those that have the potential to target high burden syndromes caused by multidrug-resistant priority pathogens, be suitable for access in terms of affordability, ease of use and storage.
Programme goals
GARDP aims to demonstrate how its unique antibiotic R&D partnership model can help address the global AMR public health failure by enabling the right antibiotic treatments to be developed and made available to people who need them.
The SBI programme has therefore set the following goals:
Goal 1
Co-develop, support regulatory approval, and make accessible new antibiotic treatments for serious bacterial infections in children and adults.
Goal 2
Make accessible a recently approved antibiotic to treat serious bacterial infections.
Goal 3
Expand portfolio to develop new treatment(s) for target pathogens, in line with GARDP’s strategy.
Our SBI projects
Development of 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.
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.
