Basilea has acquired the global rights for Venatorx 色界吧s鈥� ceftibuten-ledaborbactam etzadroxil, an antibiotic being developed for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis.
Anti-infective treatment specialist Basilea did not disclose the upfront payment made to Venatorx, though stated that tiered mid-single-digit royalties and additional potential milestone payments made to ceftibuten-ledaborbactam etzadroxil鈥檚 developer could reach $325m in total.
Ceftibuten-ledaborbactam etzadroxil is a combination of ceftibuten, a drug already approved by the US Food and Drug Administration (FDA), and Venatorx鈥檚 ledaborbactam etzadroxil. Ledaborbactam etzadroxil is the orally bioavailable prodrug of the beta-lactamase inhibitor ledaborbactam.
Enterobacterales, an order of bacteria that contains over 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, according to Basilea.
Venatorx says that in vitro聽and聽in vivo studies聽demonstrate that ledaborbactam restores the activity of ceftibuten against certain strains of Enterobacterales. 聽A Phase I single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial (NCT04243863) with ledaborbactam etzadroxi produced positive safety and efficacy results. 聽
Basilea claims that the candidate is Phase III-ready, though Venatorx has so far not made Phase II results public.
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By GlobalDataBasilea CEO David Veitch said the deal means the company will have a 鈥渃ontinuous stream of potential new product launches in the near-term future鈥�.
He added: 鈥淲e expect to start a registrational Phase III program in cUTI in about 18 months.鈥�
Ceftibuten-ledaborbactam etzadroxil has been granted Qualified Infectious Disease Product (QIDP) and fast track designations by the FDA, meaning that the drug鈥檚 eventual approval review will be expedited.
Qpex Biopharma is also eyeing an antibiotic to combat cUTIs and pyelonephritis, with its candidate ceftibuten with xeruborbactam currently in a Phase I trial.
Prioritising the end of drug resistance
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. 聽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 previously said that new antibiotics for bacteria such as Acinetobacter, Pseudomonas, and Enterobacteriaceae are urgently needed.
This has led to governments prioritising the development of drugs that are able to treat resistant strains. The UK Government is trialling an antibiotic subscription model while providing 拢210m ($267.7m) to help track antibiotic-resistant bacteria across Asia and Africa via a new surveillance system.
Venatorx itself has also received US federal funding, with grants from the National Institute of Allergy and Infectious Diseases (NIAID), the National Institutes of Health (NIH), Department of Health and Human Services (HHS) going towards ceftibuten-ledaborbactam etzadroxil鈥檚 development.
