BARDA Provides Additional Funding to Support Basilea Development of Oral Treatment for Complicated Urinary Tract Infections

BARDA Provides Additional Funding to Support Basilea Development of Oral Treatment for Complicated Urinary Tract Infections

Ad hoc announcement pursuant to Art. 53 LR

(IN BRIEF) Basilea Pharmaceutica has been awarded USD 6 million by the Biomedical Advanced Research and Development Authority to continue development of its investigational oral antibiotic ceftibuten-ledaborbactam etzadroxil for treating complicated urinary tract infections, including infections caused by multidrug-resistant bacteria. The funding will support ongoing development activities and preparation for Phase 3 clinical trials, with the potential for up to USD 147 million in additional milestone-based support. The therapy combines a beta-lactam antibiotic with a beta-lactamase inhibitor designed to overcome bacterial resistance mechanisms. The drug candidate has received FDA Fast Track and Qualified Infectious Disease Product designations and aims to address the limited availability of effective oral treatments for resistant urinary tract infections.

(PRESS RELEASE) ALLSCHWIL, 25-Feb-2026 — /EuropaWire/ — Basilea Pharmaceutica Ltd has received a USD 6 million funding award from the 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, to support the continued development of its investigational oral antibiotic ceftibuten-ledaborbactam etzadroxil. The therapy is being developed as a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination intended for the treatment of complicated urinary tract infections (cUTIs), including kidney infections such as pyelonephritis.

The funding will support further clinical development activities, including preparations for planned Phase 3 clinical studies. The agreement with BARDA includes milestone-based reimbursements that could cover a substantial portion of the programme’s development costs. Beyond the current USD 6 million tranche, the contract provides the potential for up to USD 147 million in additional non-dilutive funding to support the candidate’s progress toward commercialization.

Chief Executive Officer David Veitch noted that the continued support from BARDA strengthens Basilea’s efforts to advance the antibiotic candidate and address the growing need for oral treatment options targeting multidrug-resistant infections. The company aims to develop a therapy capable of treating complicated urinary tract infections caused by resistant bacteria, an area where effective oral treatments remain limited.

Beta-lactam/beta-lactamase inhibitor combinations are designed to overcome bacterial resistance mechanisms. Many Gram-negative pathogens produce enzymes such as extended-spectrum beta-lactamases (ESBLs), which neutralize commonly used antibiotics. Beta-lactamase inhibitors block these enzymes, restoring the effectiveness of beta-lactam antibiotics against resistant organisms and expanding treatment options for infections caused by multidrug-resistant bacteria.

Ledaborbactam etzadroxil is an orally available prodrug of ledaborbactam, a broad-spectrum boronic-acid beta-lactamase inhibitor that is being developed in combination with ceftibuten, an oral cephalosporin antibiotic. Laboratory and preclinical studies have demonstrated that the combination restores ceftibuten’s activity against Enterobacterales strains producing Ambler class A extended-spectrum beta-lactamases, class C cephalosporinases, and certain carbapenemases, including KPC and OXA-48 enzymes, as well as multidrug-resistant strains.

The investigational therapy has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration for both complicated and uncomplicated urinary tract infections. The drug candidate is currently under development and has not yet been approved for commercial use in any country.

Complicated urinary tract infections, which include infections that spread from the bladder to the kidneys, are among the most frequently encountered bacterial infections in both hospitals and community healthcare settings. Rising antibiotic resistance among causative bacteria has significantly reduced the availability of effective oral treatment options. Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor therapies active against Enterobacterales strains producing key resistance enzymes such as ESBLs, cephalosporinases, and certain carbapenemases.

Founded in 2000 and headquartered in Allschwil, Switzerland, Basilea Pharmaceutica focuses on the discovery, development, and commercialization of treatments for severe bacterial and fungal infections. The company markets Cresemba for invasive fungal infections and Zevtera for bacterial infections and maintains a pipeline of anti-infective compounds in both clinical and preclinical development. Basilea is listed on the SIX Swiss Exchange under the ticker BSLN.

About beta-lactam/beta-lactamase inhibitor (BL/BLI) combinations

Many Gram-negative bacteria express enzymes such as extended spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Beta-lactamase inhibitors block these enzymes and restore the activity of beta-lactam antibiotics against initially resistant Gram-negative bacteria, therefore BL/BLI combinations are an important addition to the armamentarium for the treatment of infections caused by multidrug-resistant bacterial pathogens.

About ceftibuten-ledaborbactam etzadroxil

Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor, which is being developed in combination with ceftibuten, an oral cephalosporin antibiotic, which is approved in the US for the treatment of upper and lower respiratory tract infections and for urinary tract infections outside the US. In vitro and in vivo studies demonstrated that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A extended spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases (KPC and OXA-48, respectively) as well as multidrug-resistant (MDR) Enterobacterales.[2] Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and Fast Track designations by the US Food and Drug Administration (FDA) for cUTI and uncomplicated urinary tract infections. Ceftibuten-ledaborbactam etzadroxil is an investigational drug and is not yet approved in any country for commercial use.

About complicated urinary tract infections (cUTI)

Complicated UTIs, which include pyelonephritis (kidney infections), are defined as urinary tract infections ascending from the bladder accompanied by local and systemic signs and symptoms and are one of the most common bacterial infections in hospital and community settings. Increasing resistance of bacteria causing complicated urinary tract infections has led to limited availability of effective oral antibiotic treatment options.[3] Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that are effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A & D serine carbapenemases (KPC and OXA-48).

About Basilea

Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.

Disclaimer

This communication expressly or implicitly contains certain forward-looking statements, such as “believe”, “assume”, “expect”, “forecast”, “project”, “may”, “could”, “might”, “will” or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.

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This ad hoc announcement can be downloaded from www.basilea.com.

References

1. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50123C00050.
2. J. A. Karlowsky, M. G. Wise, M. A. Hackel et al. Ceftibuten-Ledaborbactam Activity against Multidrug-Resistant and Extended-Spectrum-β-Lactamase-Positive Clinical Isolates of Enterobacterales from a 2018–2020 Global Surveillance Collection. Antimicrobial Agents and Chemotherapy 2022, Nov 15;66(11):e0093422
3. T. P. Lodise, T. Chopra, B. H. Nathanson et al. Epidemiology of Complicated Urinary Tract Infections due to Enterobacterales Among Adult Patients Presenting in Emergency Departments Across the United States. Open Forum Infectious Diseases 2022, Jun 24;9(7):ofac315.

SOURCE: Basilea