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Basilea Pharmaceutica Ltd, Allschwil, a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the US Department of Health and Human Services, awarded an additional USD 5.4 million of funding to Basilea to continue the development of the novel oral antibiotic ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination, for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis.
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 specific funding helps us to further advance our novel antibiotic ceftibuten-ledaborbactam, which addresses the critical unmet need for a new oral treatment of cUTIs caused by multidrug-resistant Gram-negative bacteria.”
After this additional funding of USD 5.4 million, a total of USD 30.8 million of funding has been awarded to Basilea by BARDA. The contract has the potential to provide a total of up to USD 172 million of non-dilutive funding, of which approximately USD 14 million relate to the period prior to novation of the contract to Basilea.
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.
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. 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.
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. 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).
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. The company committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections.
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