Image created by Dr. Michael J. Miller
Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) will award biotechnology company Melio US$3.5M to develop and execute a technical feasibility workplan for its culture-free platform designed to identify blood stream infections including neonatal sepsis.
Integrating cutting-edge molecular and microfluidic technologies, Melio’s diagnostic aims to enable accurate detection and identification of clinically relevant pathogens and actionable resistance markers, directly from blood within just 3 hours, whereas the current standard of care requires culture and takes multiple days. If successful, the diagnostic’s ability to test small blood volumes with high negative predictive value would fill a crucial gap in neonatal sepsis care by empowering healthcare providers to make early, targeted antimicrobial decisions—potentially saving lives, reducing unnecessary antibiotic exposure, and preventing adverse events or hospitalization at a critical early stage in life.
Neonatal sepsis is a life-threatening response to bloodstream infections that occur in newborns fewer than 28 days old. Due to their immature immune systems, newborns are particularly susceptible to infections. The BARNARDS study estimated that 2.5 million neonates or infants in the first month of life die annually of sepsis, with the greatest burden in low- and middle-income countries. Since neonatal sepsis progresses rapidly, it requires immediate treatment with IV fluids and antibiotics. The risk of death from neonatal sepsis increases 7.6% every hour a treatment is delayed.
“Melio’s technology that utilizes direct from blood isolation using acoustic technology followed by melt curve identification, if successful, would represent a great stride made to detect neonatal sepsis, a syndrome that increases the likelihood of mortality the longer treatment is delayed,” said Erin Duffy, PhD, R&D Chief of CARB-X. “We look forward to working with Melio to understand their technology better and accelerate this diagnostic so that it may reach medical staff and patients more quickly.”
“Pathogen identification tests today compromise on either the sensitivity or breadth of pathogens detected. It takes a truly disruptive approach to break this tradeoff and deliver on the ‘holy grail’ for bloodstream infections,” said Mridu Sunha, PhD, Founder and CEO of Melio. “Melio has been working tirelessly to re-examine these technical challenges with out-of-the-box thinking, engineering innovative ways to interrogate and identify pathogens that deliver comprehensive testing for known pathogens while enabling detection of emerging or novel threats. We are excited to join the CARB-X ecosystem, which connects us with a network of clinical experts and policy leaders, fostering collaboration, shared learning, and significantly accelerating our path to commercialization.”
In March 2024, CARB-X launched a new funding solicitation to fill major R&D gaps in the global antibiotic development pipeline. More than 300 Expressions of Interest were accepted in four distinct product themes: therapeutics for infections caused by Gram-negative pathogens, prevention of invasive disease, diagnostics for neonatal sepsis, and proof-of-concept for novel sample types for diagnosing lower-respiratory tract infections. Additional projects are under review, and new awards will be announced later this year. Register for the CARB-X newsletter to learn about upcoming funding calls that will be announced in 2025.
When CARB-X was founded in 2016, the early-stage antibiotic pipeline was stalled. Since its inception, CARB-X has supported 107 R&D projects in 13 countries, and CARB-X product developers have made significant progress: 18 projects have advanced into or completed clinical trials; 12 remain active in clinical development, including late-stage clinical trials; and two diagnostic products have reached the market. Additionally, at least 9 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.
CARB-X is funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) under agreement number 75A50122C00028 and by awards from Wellcome (WT224842), Germany’s Federal Ministry of Education and Research (BMBF), the UK Department of Health and Social Care’s Global Antimicrobial Resistance Innovation Fund (GAMRIF), the Public Health Agency of Canada (PHAC), the Bill & Melinda Gates Foundation, and the Novo Nordisk Foundation. The U.S. National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) in HHS, provides support in the form of in-kind services through access to a suite of preclinical services for product development. The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of any CARB-X funders.