Basilea Presents New Ceftobiprole Data at ESCMID Global 2024

Basilea Pharmaceutica Ltd, based in Allschwil, Switzerland, is a commercial-stage biopharmaceutical company focusing on developing treatments for severe bacterial and fungal infections. The company recently showcased new data on its antibiotic, ceftobiprole (Zevtera®), at the ESCMID Global 2024, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases held in Barcelona, Spain, from April 27 to 30, 2024.

Dr. Marc Engelhardt, the Chief Medical Officer at Basilea, highlighted that the new data further substantiates ceftobiprole's efficacy in treating severe bacterial bloodstream infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA), as well as pulmonary infections.

Ceftobiprole has recently received approval from the US Food and Drug Administration (FDA), supported by data from three phase 3 clinical trials: ERADICATE, which investigated the drug in patients with Staphylococcus aureus bacteremia (SAB); TARGET, which focused on acute bacterial skin and skin structure infections (ABSSSI); and a study on community-acquired bacterial pneumonia (CABP).

At ESCMID Global 2024, additional findings from the ERADICATE phase 3 study were presented through three posters. These presentations compared ceftobiprole to daptomycin in treating complicated Staphylococcus aureus bacteremia. One of the posters detailed subgroup analyses of patients with renal impairment, showing that ceftobiprole maintained consistent efficacy and safety in this specific patient group, which included individuals undergoing chronic dialysis, accounting for 13% of the study's participants. Another poster highlighted the baseline characteristics of patients in the ERADICATE study, emphasizing the complexity of the infections among the subjects. Approximately 30% of patients had multiple underlying infectious conditions or complications at the study's outset, including soft tissue infections, dialysis, abdominal and thoracic abscesses, osteoarticular infections, and right-sided endocarditis. A third poster demonstrated that median bloodstream clearance of the infection was achieved within four days of starting treatment in both the ceftobiprole and comparator groups. Notably, fewer patients treated with ceftobiprole had Staphylococcus aureus-positive blood cultures after ten days compared to those in the comparator group.

An oral presentation at the conference re-analyzed data from a prior phase 3 study on ceftobiprole in patients with community-acquired bacterial pneumonia (CABP). This study initially compared ceftobiprole with ceftriaxone, with or without linezolid, before the current FDA guidelines for CABP treatment (FDA-CABP-2020) were available. Using the FDA-CABP-2020 primary endpoint of early clinical success by day 3 after study initiation, the re-analysis confirmed ceftobiprole’s non-inferiority to the comparator treatments.

Basilea’s phase 3 program for ceftobiprole has received partial funding from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); and the Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. This collaboration awarded Basilea approximately USD 112 million, covering about 75% of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities, and pre-clinical work.

Ceftobiprole, the active form of the prodrug ceftobiprole medocaril, is a next-generation cephalosporin antibiotic administered intravenously. It demonstrates rapid bactericidal action against a broad spectrum of Gram-positive bacteria, including MRSA, and several Gram-negative bacteria. In various countries across Europe and beyond, the drug is marketed under the names Zevtera® and Mabelio® for treating hospital-acquired bacterial pneumonia (excluding ventilator-associated bacterial pneumonia) and community-acquired bacterial pneumonia. Basilea has established license and distribution agreements covering more than 80 countries. In the United States, ZEVTERA® is approved for treating Staphylococcus aureus bloodstream infections, including right-sided infective endocarditis, acute bacterial skin and skin structure infections, and community-acquired bacterial pneumonia in adults and children aged three months to under 18 years.