Basilea Pharmaceutica has received an additional USD 5.4 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, to support the continued development of its investigational oral antibiotic ceftibuten-ledaborbactam etzadroxil for the treatment of complicated Urinary Tract Infections (cUTIs), including pyelonephritis.

The latest funding brings BARDA's total financial support for the programme to USD 30.8 million. Under the existing agreement, Basilea could receive up to USD 172 million in non-dilutive funding, including approximately USD 14 million allocated before the contract was transferred to the company.

The investigational therapy combines ceftibuten, an oral cephalosporin antibiotic, with ledaborbactam etzadroxil, an orally bioavailable prodrug of the novel broad-spectrum beta-lactamase inhibitor ledaborbactam. The beta-lactam/beta-lactamase inhibitor (BL/BLI) combination is being developed to address complicated urinary tract infections caused by multidrug-resistant Gram-negative bacteria, an area where effective oral treatment options remain limited.

David Veitch, Chief Executive Officer of Basilea, said, "We thank BARDA for their continued collaboration and support for the development of novel anti-infectives to help patients with severe infections. This funding will help us further advance ceftibuten-ledaborbactam, which addresses the critical unmet need for a new oral treatment for complicated urinary tract infections caused by multidrug-resistant Gram-negative bacteria."

Complicated urinary tract infections, including kidney infections such as pyelonephritis, are among the most common bacterial infections encountered in both hospitals and community healthcare settings. Rising antimicrobial resistance has significantly reduced the effectiveness of existing oral antibiotics, creating an urgent need for new therapies capable of treating resistant pathogens.

According to Basilea, preclinical studies have demonstrated that ledaborbactam etzadroxil restores the antibacterial activity of ceftibuten against a broad range of resistant Enterobacterales, including strains producing extended-spectrum beta-lactamases (ESBLs), class C cephalosporinases, and class A and D carbapenemases such as KPC and OXA-48. These resistance mechanisms are among the leading causes of treatment failure with conventional antibiotics.

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

Basilea believes the programme could address a significant gap in antimicrobial treatment, as there are currently no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations that effectively target multidrug-resistant Enterobacterales expressing these resistance enzymes.

Headquartered in Switzerland, Basilea Pharmaceutica is focused on discovering, developing and commercialising innovative therapies for patients with severe bacterial and fungal infections. The latest BARDA funding reinforces the strategic collaboration between the two organisations to accelerate the development of new anti-infective therapies that address the growing global challenge of antimicrobial resistance.