Basilea Pharmaceutica Ltd, a Switzerland-based commercial-stage biopharmaceutical company, has signed an exclusive license agreement with Venatorx Pharmaceuticals, Inc. to acquire worldwide rights to ceftibuten-ledaborbactam etzadroxil. The oral beta-lactam/beta-lactamase inhibitor (BL/BLI) combination is phase 3-ready and being developed as a potential treatment for complicated urinary tract infections (cUTI), including pyelonephritis.

The combination pairs ceftibuten, an oral cephalosporin antibiotic, with ledaborbactam etzadroxil, the prodrug of a novel beta-lactamase inhibitor. Together, they have demonstrated bactericidal activity against multidrug-resistant Enterobacterales, the leading cause of cUTI. With cUTIs contributing to over 600,000 hospital admissions annually in the United States, the therapy could provide a much-needed oral treatment option to reduce hospitalizations. Early-stage studies have shown the drug to be safe and well tolerated.

David Veitch, CEO of Basilea, said the agreement strengthens the company’s late-stage pipeline and aligns with its strategy to ensure a steady flow of product launches. “Ceftibuten-ledaborbactam etzadroxil holds strong promise in addressing critical unmet needs in the oral treatment of cUTI caused by multidrug-resistant Gram-negative bacteria. We anticipate initiating a registrational phase 3 program in about 18 months,” he noted.

Under the terms, Basilea will make an upfront payment along with milestone payments in 2025. Venatorx may receive tiered mid-single-digit royalties and additional commercial milestone payments of up to USD 325 million, subject to regulatory approval and commercialization success. The deal is expected to add around CHF 15 million to Basilea’s 2025 research and development expenses, including the upfront and pre-commercial milestone payments. Updated financial guidance will be shared with the half-year earnings report in August 2025.

Beta-lactamase inhibitors play a key role in combating resistance by restoring the activity of beta-lactam antibiotics against resistant Gram-negative pathogens. Ceftibuten-ledaborbactam etzadroxil has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the US FDA for the treatment of cUTI and uncomplicated UTI.

Currently, no approved oral BL/BLI combinations are available to treat infections caused by ESBL-producing and carbapenemase-expressing Enterobacterales. If successful, Basilea’s new candidate could become the first of its kind to address this significant therapeutic gap.