Basilea Secures New BARDA Funding to Address Multidrug-Resistant Gram-Negative Infections

(IN BRIEF) Basilea Pharmaceutica Ltd has received an additional USD 5.4 million from BARDA to continue development of its novel oral antibiotic ceftibuten-ledaborbactam etzadroxil. The antibiotic is being developed for complicated urinary tract infections, including pyelonephritis, particularly infections caused by multidrug-resistant Gram-negative bacteria. With the new award, total BARDA funding to Basilea has reached USD 30.8 million. The contract could provide up to USD 172 million in non-dilutive funding. Ceftibuten-ledaborbactam etzadroxil has received QIDP and Fast Track designations from the U.S. FDA for complicated and uncomplicated urinary tract infections, but it remains investigational and is not yet approved for commercial use in any country.

(PRESS RELEASE) ALLSCHWIL, 5-Aug-2026 — /EuropaWire/ — Basilea Pharmaceutica Ltd, a commercial-stage biopharmaceutical company focused on severe bacterial and fungal infections, has received an additional USD 5.4 million in funding from the Biomedical Advanced Research and Development Authority, known as BARDA, to continue development of its novel oral antibiotic ceftibuten-ledaborbactam etzadroxil.

BARDA is part of the Administration for Strategic Preparedness and Response, or ASPR, within the U.S. Department of Health and Human Services.

The additional funding will support further development of ceftibuten-ledaborbactam etzadroxil for the treatment of complicated urinary tract infections, or cUTIs, including pyelonephritis.

Ceftibuten-ledaborbactam etzadroxil is a beta-lactam/beta-lactamase inhibitor combination, also known as a BL/BLI combination.

Basilea said the antibiotic is being developed to address a critical unmet need for new oral treatment options for complicated urinary tract infections caused by multidrug-resistant Gram-negative bacteria.

David Veitch, Chief Executive Officer of Basilea, thanked BARDA for its continued collaboration and support in the development of novel anti-infectives for patients with severe infections.

He said the additional funding will help Basilea further advance ceftibuten-ledaborbactam, which targets an important treatment gap in cUTIs caused by resistant Gram-negative pathogens.

Following the new USD 5.4 million award, the total amount of BARDA funding awarded to Basilea has reached USD 30.8 million.

The contract has the potential to provide up to USD 172 million in non-dilutive funding.

Of that total, approximately USD 14 million relates to the period before the contract was novated to Basilea.

Many Gram-negative bacteria express enzymes such as extended-spectrum beta-lactamases, known as ESBLs, which can make commonly used antibiotics ineffective.

Beta-lactamase inhibitors are designed to block these enzymes and restore the activity of beta-lactam antibiotics against bacteria that would otherwise be resistant.

For this reason, BL/BLI combinations are considered an important part of the treatment options for infections caused by multidrug-resistant bacterial pathogens.

Ledaborbactam etzadroxil is the orally bioavailable prodrug of ledaborbactam, a novel broad-spectrum boronic acid beta-lactamase inhibitor.

It is being developed in combination with ceftibuten, an oral cephalosporin antibiotic.

Ceftibuten is approved in the United States for upper and lower respiratory tract infections and is approved for urinary tract infections outside the United States.

Basilea said in vitro and in vivo studies have shown that ledaborbactam etzadroxil restores the activity of ceftibuten against strains of Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A and D carbapenemases, including KPC and OXA-48.

The combination has also shown activity against multidrug-resistant Enterobacterales.

Ceftibuten-ledaborbactam etzadroxil has received Qualified Infectious Disease Product, or QIDP, designation and Fast Track designation from the U.S. Food and Drug Administration for complicated urinary tract infections and uncomplicated urinary tract infections.

The product remains investigational and has not yet been approved for commercial use in any country.

Complicated urinary tract infections include kidney infections, or pyelonephritis.

They are defined as urinary tract infections ascending from the bladder and accompanied by local and systemic signs and symptoms.

Basilea said cUTIs are among the most common bacterial infections in both hospital and community settings.

Increasing antimicrobial resistance among bacteria causing complicated urinary tract infections has limited the availability of effective oral antibiotic treatment options.

According to Basilea, there are currently no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations effective against Enterobacterales expressing Ambler class A ESBLs, class C cephalosporinases, and class A and D serine carbapenemases, including KPC and OXA-48.

Basilea is headquartered in Switzerland and was founded in 2000.

The company discovers, develops and commercialises medicines for severe bacterial and fungal infections.

It has launched two hospital brands: Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections.

Basilea also has preclinical and clinical anti-infective assets in its portfolio.

The company is listed on the SIX Swiss Exchange under the ticker symbol BSLN.

Basilea noted that this communication contains forward-looking statements relating to its business, including the progress, timing and completion of research, development and clinical studies for product candidates.

The company said such statements involve known and unknown risks, uncertainties and other factors that could cause actual results, financial condition, performance or achievements to differ materially from those expressed or implied.

Basilea stated that it does not undertake to update forward-looking statements as a result of new information, future events or other developments.

Through the additional BARDA funding, Basilea is advancing the development of a novel oral antibiotic candidate aimed at strengthening treatment options for complicated urinary tract infections caused by multidrug-resistant Gram-negative bacteria.

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.

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

References

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.
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
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.

Media Contact:

Peer Nils Schröder, PhD
Head of Corporate Communications & Investor Relations
Basilea Pharmaceutica International Ltd, Allschwil
Hegenheimermattweg 167b
4123 Allschwil, Switzerland
Phone: +41 61 606 1102
E-mail: media_relations@basilea.com
investor_relations@basilea.com

SOURCE: Basilea

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