ALLSCHWIL, Switzerland — May 28, 2026
Basilea Pharmaceutica announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, has awarded the company an additional USD 13.3 million to support continued development of its investigational oral antibiotic ceftibuten-ledaborbactam etzadroxil for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis. The funding will help advance the program toward preparation for a planned Phase 3 clinical development program targeting multidrug-resistant Gram-negative bacterial infections.
BARDA Expands Support for Multidrug-Resistant Infection Program
The newly announced funding increases BARDA’s total committed support for the antibiotic program to approximately USD 25 million. Under the broader development agreement, Basilea may potentially receive up to USD 133 million in additional non-dilutive funding as the program progresses through later-stage development milestones.
According to David Veitch, Chief Executive Officer of Basilea, the partnership with BARDA represents an important step in accelerating development of urgently needed oral therapies for resistant bacterial infections. He noted that ceftibuten-ledaborbactam etzadroxil could help address the growing unmet need for effective oral treatment options against multidrug-resistant Gram-negative pathogens responsible for complicated urinary tract infections.
Complicated urinary tract infections remain among the most common serious bacterial infections globally and frequently require hospitalization or intravenous antibiotics due to rising antimicrobial resistance. Increasing resistance among Enterobacterales and other Gram-negative pathogens has significantly reduced the effectiveness of currently available oral antibiotics.
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Novel Beta-Lactam Combination Targets Resistant Bacteria
Ceftibuten-ledaborbactam etzadroxil combines ceftibuten, an oral cephalosporin antibiotic, with ledaborbactam etzadroxil, an orally bioavailable prodrug of a novel broad-spectrum boronic acid beta-lactamase inhibitor. The investigational therapy is specifically designed to restore antibiotic activity against resistant bacterial strains expressing enzymes such as extended-spectrum beta-lactamases (ESBLs), AmpC cephalosporinases, and carbapenemases including KPC and OXA-48.
Beta-lactamase enzymes are a major driver of antimicrobial resistance because they deactivate commonly used antibiotics, limiting treatment effectiveness and increasing reliance on hospital-based intravenous therapies. Basilea stated that the investigational combination demonstrated strong in vitro and in vivo activity against multidrug-resistant Enterobacterales in preclinical studies.
Importantly, there are currently no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations capable of effectively targeting Enterobacterales expressing these resistance mechanisms. If successfully developed, ceftibuten-ledaborbactam etzadroxil could represent a significant advancement in outpatient management of resistant bacterial infections.
The investigational therapy has already received both Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration for complicated and uncomplicated urinary tract infections, potentially supporting expedited regulatory review pathways.
Basilea Strengthens Anti-Infective Development Pipeline
Basilea Pharmaceutica continues to expand its anti-infective pipeline as global concern over antimicrobial resistance intensifies. The Switzerland-based commercial-stage biopharmaceutical company has established a strong presence in hospital anti-infectives through marketed products including Cresemba for invasive fungal infections and Zevtera for bacterial infections.
The additional BARDA support underscores continued public-private collaboration aimed at accelerating development of urgently needed antimicrobial therapies. Industry experts increasingly view novel oral antibiotic options as critical for reducing hospitalization burden, improving patient access, and helping combat the growing threat of multidrug-resistant bacterial infections worldwide.
If future clinical studies are successful, ceftibuten-ledaborbactam etzadroxil could emerge as an important new oral treatment option for serious resistant urinary tract infections, an area where therapeutic choices remain extremely limited.
Source: Basilea press release
