Basilea Secures BARDA Support for Novel Oral Antibiotic Development

Basilea Pharmaceutica Ltd, a Swiss commercial-stage biopharmaceutical company, has secured US government backing to advance a promising oral antibiotic for severe infections.

BARDA Contract Novation

The Biomedical Advanced Research and Development Authority (BARDA), part of the ASPR under the US Department of Health and Human Services, has novated a contract from Venatorx Pharmaceuticals to Basilea.

This agreement supports the development of ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for treating complicated urinary tract infections (cUTIs), including pyelonephritis.

Basilea recently acquired the global rights to this antibiotic from Venatorx.

CEO Statement

David Veitch, CEO of Basilea, said:

“We thank BARDA for their collaboration and support in advancing novel anti-infectives. This funding strengthens our development of ceftibuten-ledaborbactam, which addresses critical unmet needs in oral cUTI treatment.”

Funding Details

The contract was transferred with Basilea replacing Venatorx as the contracting party. Basilea will receive non-dilutive funding, beginning with approximately USD 6 million. Additional funding—up to USD 153 million—will be provided upon achieving predefined development milestones, including planned phase 3 clinical studies.

The Antibiotic’s Mechanism

Gram-negative bacteria often resist treatment through enzymes like extended spectrum beta-lactamases (ESBL).

Beta-lactamase inhibitors neutralize these enzymes, restoring antibiotic effectiveness. BL/BLI combinations remain vital tools against multidrug-resistant pathogens.

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

It is combined with ceftibuten, an oral cephalosporin approved in the US for respiratory infections and outside the US for urinary tract infections.

In vitro and in vivo data show this combination restores ceftibuten’s activity against resistant Enterobacterales, including ESBLs, cephalosporinases, and carbapenemases like KPC and OXA-48.

Regulatory Status

Ceftibuten-ledaborbactam etzadroxil has received FDA Qualified Infectious Disease Product (QIDP) and Fast Track designations for both complicated and uncomplicated urinary tract infections.

The drug remains investigational and is not yet approved in any country.

Clinical Context

Complicated UTIs, including pyelonephritis, are among the most common bacterial infections in hospitals and communities.

Rising resistance has sharply reduced effective oral antibiotic options.

Currently, no approved oral BL/BLI combinations effectively target Enterobacterales expressing ESBLs, cephalosporinases, or carbapenemases.

About Basilea

Founded in 2000 and headquartered in Switzerland, Basilea is dedicated to discovering, developing, and commercializing innovative treatments for severe bacterial and fungal infections.

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