CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) has awarded Swiss biopharmaceutical company Debiopharm an additional $12.3 million grant to advance the clinical development of Debio 1453, a first-in-class antibiotic designed to combat drug-resistant Neisseria gonorrhoeae infections. This funding represents a significant milestone in addressing the growing threat of antibiotic-resistant gonorrhea, which has become a major public health concern worldwide.
Novel Mechanism Targets Critical Bacterial Pathway
Debio 1453 operates through a unique mechanism of action as a potent inhibitor of the essential fatty acid synthesis enzyme FabI found in N. gonorrhoeae and select other bacterial species. Preclinical studies have demonstrated that the compound rapidly triggers bactericidal activity both in vitro and in vivo against N. gonorrhoeae, offering potential for treating difficult infections caused by this pathogen.
"Debio 1453 represents an approach to resistance targeting that CARB-X is proud to support. With its novel mechanism of action and novelty in chemistry, this first-in-class antibiotic has the potential to offer a durable solution to treating gonorrhea, for which all but one antibiotic has been rendered ineffective," said Erin Duffy, PhD, R&D Chief of CARB-X.
Structured Development Program
The newly awarded grant builds upon an initial $7.9 million USD investment that enabled Debio 1453's progression through preclinical research. The $12.3 million funding is structured in two parts: Part 1 will support advancement to Phase I first-in-human evaluation, while Part 2 will be considered based on achievement of predetermined milestones. Combined with the initial grant, CARB-X's total projected investment exceeds $20 million USD to transition Debio 1453 from preclinical to clinical stage, including timely commencement of Phase 2 evaluation.
"We are very pleased to receive this additional commitment from CARB-X for Debio 1453. This further confirms our strong pre-clinical proof-of-concept obtained for the treatment of gonorrhea," explained Morgane Vanbiervliet, Director, Global Development and Licensing at Debiopharm. "CARB-X's commitment closely aligns with our own vision to establish a new standard of care for the treatment of N. gonorrhoeae infections, by developing an antibiotic with an entirely new mechanism of action and offering a crucial treatment alternative against multi-drug-resistant infections."
Addressing Urgent Public Health Need
The development of Debio 1453 addresses a critical gap in treatment options for gonorrhea, as N. gonorrhoeae has developed resistance to existing antibiotics. The infection can lead to serious complications including pelvic inflammatory disease, infertility, and increased risk of other infections. Additionally, gonorrhea can be transmitted from pregnant mothers to babies, potentially causing sepsis and neonatal conjunctivitis, which can lead to blindness if untreated.
Recent epidemiological data underscore the urgency of this medical need. In 2023, the United States reported 601,319 cases of gonorrhea, making it the second most common nationally notifiable sexually transmitted infection in the country. The situation in Europe is equally concerning, with 96,969 confirmed cases reported across 28 EU/EEA countries in 2023, representing a notification rate of 25.0 cases per 100,000 individuals and marking a 31% increase from 2022.
Global Priority Recognition
The significance of developing new treatments for drug-resistant N. gonorrhoeae is recognized at the highest levels of global health organizations. The World Health Organization has ranked the development of new antibiotics effective against N. gonorrhoeae as high priority, while the US Centers for Disease Control and Prevention considers drug-resistant N. gonorrhoeae an urgent threat.
CARB-X's support for this project is provided through federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority, along with awards from Wellcome, Germany's Federal Ministry of Education and Research, the UK Department of Health and Social Care as part of the Global Antimicrobial Resistance Innovation Fund, and the Novo Nordisk Foundation.
