delivering NEW SOLUTIONS
Serious bacterial infections are a major cause of death in hospitals and healthcare settings. Bacteria can enter the body through wounds and surgery sites, ventilators, and intravenous or urinary catheters, leading to pneumonia, urinary tract, abdominal, soft tissue, and bloodstream infections. Drug resistance is making these infections increasingly difficult to treat.
Surgical procedures and chemotherapy put patients at greater risk of bacterial infections. Between 39% and 51% of bacteria that can cause surgical-site infections and 27% of bacteria capable of causing post-chemotherapy infections are now resistant to commonly used antibiotics in the US. These risks are amplified for patients in low- and middle-income countries (LMICs) due to factors such as inadequate sanitation and infection control, as well as a lack of suitable diagnostics and effective treatments.
our priority
Finding treatments for Gram-negative bacteria
The most difficult-to-treat hospital infections are caused by Gram-negative bacteria, which have evolved and/or acquired genetic material from other bacteria to become resistant to most antibiotic treatments and can pass along these traits.
Some of these bacteria have become resistant to carbapenems, which are considered antibiotics of last resort. Therefore, the WHO identifies carbapenem-resistant Gram-negative bacteria as ‘critical level’ priority pathogens that urgently require new treatments and as being among the greatest threats to health. GARDP is working with its partners to develop novel treatments for these dangerous bacterial infections.
BEHIND THE SCENES
Limiting the impact of COVID-19
COVID-19 has had a significant impact on the fight against antibiotic resistance. First, it has contributed to the problem directly as hospitals around the world treating seriously ill patients have been pushed to maximum capacity, leading to increased use of antibiotics and outbreaks of antibiotic-resistant infections.
Nevertheless, Venatorx has been able to continue developing its product portfolio, which includes antibiotic and antiviral drugs: “We, like many others, suffered last year, but we're back up and running.” said Christopher Burns, President and CEO, Venatorx Pharmaceuticals (US).
Kamini Walia, Senior Scientist at the Indian Council of Medical Research (ICMR), recognized that their antimicrobial stewardship programme “definitely took a hit from the COVID outbreak for multiple reasons, like staff being diverted to COVID-related activities.” Even so, Walia noted that the ICMR was still able to capture important data on antimicrobial use in patients with COVID-19 and other diseases.
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We made significant progress in our efforts to address serious bacterial infections, which are among the major causes of disability and death for people in healthcare settings.
Delivering new solutions
Deliver Access for All
COMPLETED
enrolment for the pivotal phase 3 trial of cefepime–taniborbactam, a promising new antibiotic treatment
identifiED
sites to be part of a network in India and South Africa that will improve our understanding of how to treat drug-resistant infections in adults and children
initiated
an agreement to deliver access to cefiderocol in the countries that need it most
paving the way for approval of cefepime-taniborbactam
GARDP is collaborating with Venatorx on cefepime–taniborbactam, a promising new antibiotic combination. This compound offers a potential treatment option for patients with serious infections caused by highly resistant bacteria, including those resistant to existing last-resort carbapenem antibiotics.
In 2021, we conducted site feasibility assessments in India and South Africa for an observational study that will further examine existing treatment paradigms for patients with serious carbapenem-resistant bacterial infections.
Last year also saw the completion of patient recruitment for the pivotal phase 3 trial of cefepime–taniborbactam, which will pave the way for the initial drug registration and eventual approval of this potential new combination treatment for clinical use. Once approved, Venatorx has granted GARDP exclusive rights to license and distribute cefepime–taniborbactam throughout most LMICs, which, in giving these countries access to a new treatment option where existing last-resort antibiotics are not enough, would be a significant breakthrough.
Expanding access to cefiderocol
With its novel ‘trojan horse’ Gram-negative bacteria penetration mechanism, cefiderocol is a potential new treatment option for priority antibiotic-resistant infections. First approved in 2019, cefiderocol is active against many types of Gram-negative bacteria and is currently approved for use in the US and the EU.
In July 2021, GARDP signed a Memorandum of Understanding (MOU) with the Clinton Health Access Initiative (CHAI) and Shionogi & Co., Ltd to accelerate access—including in LMICs—to cefiderocol for bacterial infections in patients with limited treatment options.
Our next challenge?
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We have made good progress towards the development of new treatment options for serious bacterial infections. Together with Venatorx we aim to gain regulatory approval for cefepime-taniborbactam. We are focused more than ever on completing plans to expand access for this and other much-needed treatments.
