The Biomedical Advanced Research and Development Authority (BARDA) in the US will support Basilea’s development of a new type of oral antibiotic to treat complicated urinary tract infections (cUTIs).
The contract will see BARDA, part of the US Department of Health and Human Services’ (HHS) Administration for Strategic Preparedness and Response (ASPR), reimburse Basilea for the costs of bringing the antibiotic to market – including planned Phase III trials.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
BARDA will provide non-dilutive funding comprising an initial $6m, with a further $153m available if predefined milestones are met.
Basilea is developing ceftibuten-ledaborbactam etzadroxil, a beta-lactam/beta-lactamase inhibitor (BL/BLI) combination. Last month, the Swiss biopharma acquired global rights to the drug from Venatorx Pharmaceuticals in a licensing deal that could reach $325m in total.
Venatorx already had a contract with BARDA, meaning the one the agency awarded Basilea is a replacement.
In a statement, Basilea said: “The existing funding agreement between BARDA and Venatorx was novated, with Basilea replacing Venatorx as a contracting party.”
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalDataCeftibuten-ledaborbactam etzadroxil is a combination of ceftibuten, a drug already approved by the US Food and Drug Administration (FDA), and Venatorx-developed ledaborbactam etzadroxil. Ledaborbactam etzadroxil is the orally bioavailable prodrug of the beta-lactamase inhibitor ledaborbactam.
Enterobacterales, an order of bacteria that contains more than 250 species, is known for being resistant to current standard-of-care (SoC) oral and intravenous (IV) antibiotics. This is a major cause of cUTIs, hard-to-treat infections that account for more than 600,000 hospital admissions a year.
More broadly, many Gram-negative bacteria express enzymes such as extended-spectrum beta-lactamases (ESBL) that confer resistance against commonly used antibiotics. Basilea states that BL/BLI combos, which block these enzymes, are an important addition to pharma’s antibiotic armoury.
At the time of the licensing deal with Venatorx in August, Basilea’s CEO David Veitch said the company “expects to start a registrational Phase III program in cUTI in about 18 months”. This would give a rough target of February 2027.
Basilea has two anti-infective drugs on the market, antifungal Cresemba (isavuconazole) and antibiotic Zevtera (ceftobiprole).
Basilea also has another ongoing contract with BARDA supporting the development of a pipeline of new antifungals – the total funding of which could reach $268m.
Drug resistance a “global concern”
Drug-resistant infections have become a major burden for many health systems. Reliance on antibiotics has meant bacteria have developed defence mechanisms through genetic mutations.
In the US, more than 2.8 million antimicrobial-resistant infections occur each year, according to the US Centers for Disease Control and Prevention (CDC). The World Health Organization (WHO) has said that drug-resistant infections are a “global concern”.
This has led to governments prioritising the development of drugs that are able to treat resistant strains. BARDA has established initiatives and issued several contracts to combat antimicrobial resistance. Meanwhile, the UK Government is trialling an antibiotic subscription model while also providing £210m ($267.7m) to help track antibiotic-resistant bacteria across Asia and Africa via a new surveillance system.
