Basilea receives further USD 6 million from BARDA to continue development of novel antibiotic ceftibuten-ledaborbactam

Core Viewpoint - Basilea Pharmaceutica Ltd has received a USD 6 million award from BARDA to further develop its novel oral antibiotic ceftibuten-ledaborbactam etzadroxil for treating complicated urinary tract infections (cUTIs) [1][2]. Group 1: Funding and Development - The funding from BARDA will support the preparation of clinical phase 3 studies for ceftibuten-ledaborbactam etzadroxil, which addresses the unmet medical need for oral treatment of cUTIs caused by multidrug-resistant bacteria [2]. - Under the contract with BARDA, Basilea could receive up to USD 147 million in additional non-dilutive funding upon completing predefined milestones [2]. Group 2: Product Information - Ceftibuten-ledaborbactam etzadroxil is a combination of a novel broad-spectrum beta-lactamase inhibitor and an oral cephalosporin antibiotic, which has shown effectiveness against resistant strains of Enterobacterales [4]. - The drug has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA for cUTI and uncomplicated urinary tract infections, indicating its potential significance in treating these conditions [4]. Group 3: Market Context - Complicated urinary tract infections, including pyelonephritis, are common bacterial infections with increasing resistance, leading to limited effective oral antibiotic options [5]. - Currently, there are no approved oral beta-lactam or beta-lactam/beta-lactamase inhibitor combinations effective against resistant Enterobacterales, highlighting the market need for ceftibuten-ledaborbactam etzadroxil [5]. Group 4: Company Overview - Basilea is a commercial-stage biopharmaceutical company founded in 2000, focused on developing innovative drugs for severe bacterial and fungal infections [6][7]. - The company has successfully launched two hospital brands, Cresemba and Zevtera, and has a portfolio of preclinical and clinical anti-infective assets [6][7].