Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) has awarded Exhalon US$1M in seed funding to evaluate whether exhaled breath can be used as a non-invasive sample type to aid in the rapid and accurate diagnosis of lower-respiratory tract infections (LRTIs).
Diagnosing LRTIs by traditional microbiological approaches can be complicated due to the difficulty of acquiring lower respiratory specimens, such as sputum or samples collected by more invasive methods, as well as the complexity and often poor quality of samples collected for diagnostic testing.
The CARB-X award will support Exhalon’s evaluation of the diagnostic capability of a non-invasive test evaluating volatile organic compounds (VOC) in exhaled breath. A multicenter clinical study will enroll all ages of patients, including intubated patients, with suspected LRTIs. The study will identify VOC signatures in the breath that originate from the patient’s response to infection and the infecting microbes. The clinical study aims to establish the feasibility of using unique VOC signatures to indicate infection status, distinguish bacterial versus viral infections, and identify the causative pathogens.
The study findings are intended to provide the foundation for the development of a robust, rapid (one-minute or less), and non-invasive diagnostic test that could accelerate LRTI diagnosis in various clinical settings and improve patient management and outcomes, including antibiotic decision-making.
Exhaled breath test
“We look forward to supporting Exhalon’s initial clinical study to evaluate whether an exhaled breath test can detect the status of infection and identify the causative pathogen,” said Richard Alm, PhD, Interim Chief of R&D at CARB-X. “If successful, Exhalon’s approach could mark a major advance in non-invasive diagnostics, helping clinicians make faster, better-informed treatment decisions.”
“By turning a patient’s single breath into a diagnostic, we aim to demonstrate that the real time analysis of volatile organic compounds in exhaled breath can transform the management of respiratory infections, supporting faster, better-targeted decisions and strengthening antibiotic stewardship worldwide,” said Professor Stanislas Grassin-Delyle, principal investigator at Exhalon.
Major threat
LRTIs are leading causes of illness and death worldwide, and pneumonia is the leading infectious cause of death in children under five, claiming the lives of over 700,000 children each year globally. Due to the lack of widespread rapid diagnostic testing for LRTI, broad-spectrum antibiotics are often prescribed prior to confirmation of infection and identification of the infectious agent. As such, the patient may not receive treatment tailored to their infection, and treatment in the absence of diagnosis can contribute to overuse of antibiotics and rising patterns of resistance to current antibiotic therapies.
In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibacterial development pipeline. More than 300 initial applications were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, novel approaches to the prevention of invasive disease caused by Staphylococcus aureus or Escherichia coli, diagnostics for neonatal sepsis, proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Ten awards were announced from the first cycle of the 2024 funding round. Additional projects from the second cycle will be announced this year. CARB-X will begin accepting applications for the second cycle of the 2025 funding round from December 1 to December 12.
Antibacterial pipeline stalled
When CARB-X was founded in 2016, the early-stage antibacterial pipeline was stalled. Since its inception, CARB-X has supported 121 R&D projects in 15 countries, and CARB-X product developers have made significant progress: 22 projects have advanced into or completed clinical trials; 14 remain active in clinical development, including late-stage clinical trials; and 3 products have reached the market.
Additionally, more than 10 product developers with active R&D projects have already secured advanced development partnerships to support their clinical development after leaving the CARB-X portfolio. All CARB-X-funded product developers are contractually obligated to develop a Stewardship and Access Plan for their product, outlining strategies to ensure responsible stewardship and appropriate access in low- and middle-income countries.
No comments yet