Allschwil, Switzerland, May 03, 2024
Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that scientific presentations with new data on its antibiotic ceftobiprole (Zevtera®) have been presented at ESCMID Global 2024, the annual meeting of the European Society of Clinical Microbiology and Infectious Diseases, which took place from April 27 to 30, 2024 in Barcelona, Spain.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at ESCMID Global 2024 provide further evidence for the differentiated profile of ceftobiprole in the treatment of severe bacterial bloodstream infections, including those involving methicillin-resistant Staphylococcus aureus, MRSA, and pulmonary infections.”
Ceftobiprole was recently approved by the US Food and Drug Administration (FDA), supported by data from three phase 3 studies: ERADICATE, conducted in patients with Staphylococcus aureus bacteremia (SAB), TARGET, in acute bacterial skin and skin structure infections (ABSSSI), and a study in community-acquired bacterial pneumonia (CABP).1, 2, 3
Additional data from the ERADICATE phase 3 study were presented in three posters, comparing ceftobiprole to daptomycin in the treatment of complicated Staphylococcus aureus bacteremia. One poster focused on subgroup analyses in patients with renal impairment, demonstrating consistent efficacy and safety of ceftobiprole in this specific patient group, which included patients with chronic dialysis, representing 13% of patients in the ERADICATE study. Furthermore, baseline characteristics of patients in the ERADICATE study were presented, underlining the complexity of the infections in the studied patient population, with about 30% of patients presenting with more than one underlying infectious condition, foci, or complications at baseline, including soft tissue infections, dialysis, abdominal and thoracic abscesses, osteoarticular infections and right-sided endocarditis. Data presented on a third poster demonstrated that bloodstream clearance was achieved at a median of four days after the start of treatment in both the ceftobiprole and comparator groups. In the group treated with ceftobiprole, fewer patients had Staphylococcus aureus-positive blood cultures after ten days compared to the comparator treatment group.
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
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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
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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
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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
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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
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