Basilea reports presentation of new data for ceftobiprole (Zevtera) at ESCMID Global 2024 - Seite 2

An oral presentation focused on a re-analysis of the previously conducted ceftobiprole phase 3 study in patients with community-acquired bacterial pneumonia (CABP). The study compared ceftobiprole with ceftriaxone ± linezolid and was performed prior to the availability of the current FDA guidance for the development of drugs for the treatment of CABP (FDA-CABP-2020). Using the FDA-CABP-2020 primary endpoint of early clinical success at day 3 after study start, this re-analysis supported the non-inferiority of ceftobiprole to ceftriaxone ± linezolid.

Basilea’s phase 3 program for ceftobiprole is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Through this partnership, Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the SAB and ABSSSI phase 3 studies, regulatory activities and non-clinical work.

Ceftobiprole data presented at ESCMID Global 2024
–	Poster P0769 / Abstract 1493 – Ceftobiprole is safe and efficacious in treating renally impaired patients with complicated Staphylococcus aureus Bacteremia (SAB), including those on dialysis – results from the ERADICATE Phase 3 study – M. Engelhardt, S. E. Cosgrove, S. B. Doernberg, T. C. Jenkins, N. A. Turner, H. W. Boucher, M. Jones, D. Ionescu, J. Smart, M. Saulay, V. G. Fowler, Jr
–	Poster P0771 / Abstract 1559 – An analysis of baseline conditions or complications of S. aureus bacteremia from a double-blind randomized Phase 3 study (ERADICATE) comparing ceftobiprole versus daptomycin – T. L. Holland, S. E. Cosgrove, S. B. Doernberg, T. C. Jenkins, N. A. Turner, H. W. Boucher, M. Jones, D. Ionescu, J. Smart, M. Saulay, M. Engelhardt, V. G. Fowler, Jr
–	Poster P0774 / Abstract 1577 – Comparison of ceftobiprole versus daptomycin for time to S. aureus bloodstream clearance in the recent double-blind randomized Phase 3 study (ERADICATE) – T. L. Holland, S. E. Cosgrove, S. B. Doernberg, T. C. Jenkins, N. A. Turner, H. W. Boucher, M. Jones, D. Ionescu, J. Smart, M. Saulay, M. Engelhardt, V. G. Fowler, Jr
–	Abstract O1068 – Ceftobiprole versus ceftriaxone ± linezolid in community-acquired bacterial pneumonia (CABP): Re-analysis of a Phase 3 study according to the FDA-CABP-2020 guidance – T. Welte, M. Engelhardt, M. Jones, S. Friedmann, D. Ionescu, M. Saulay, J. Smart, A. Shorr