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Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023

  • Eight presentations on antibiotic ceftobiprole providing further evidence for its activity against methicillin-resistant Staphylococcus aureus (MRSA) and other clinically relevant pathogens

Allschwil, Switzerland, October 17, 2023

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 Infectious Disease Week (IDWeek) 2023, highlighting its utility for the treatment of severe bacterial infections.

IDWeek is the annual meeting of the Infectious Diseases Society of America (IDSA), jointly held with other infectious diseases societies in the US, and took place in Boston, Massachusetts (USA) from 11 to 15 October 2023.

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens. It also provides results of pharmacokinetic-pharmacodynamic modeling supporting the dosing regimens to treat severe bacterial infections from the successful clinical phase 3 studies. These studies were conducted in patients with Staphylococcus aureus bacteremia (SAB), acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). These are the three indications included in our New Drug Application, which is currently under priority review with the US FDA, with a Prescription Drug User Fee Act (PDUFA) goal date of 03 April 2024.”

Data from four presentations, building on pharmacokinetic-pharmacodynamic modeling, provided evidence that the exposure achieved with the applied dosing regimens was efficacious for the treatment of Staphylococcus aureus bacteremia (SAB) in the ERADICATE phase 3 study. The same was also shown in analyses for the ceftobiprole phase 3 studies in acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP).

Four additional abstracts included data from large in-vitro susceptibility studies testing bacterial isolates from US patients, which confirmed that ceftobiprole exhibits potent in-vitro activity against methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA, MRSA), as well as against Streptococcus pneumoniae and Enterococcus faecalis, and retained its potency over the surveillance period of several years against these clinically relevant pathogens.

The presented data were generated in collaboration with the Institute for Clinical Pharmacodynamics, Schenectady, New York (USA), JMI Laboratories, North Liberty, Iowa, (USA) and the Duke Clinical Research Institute, Durham, North Carolina (USA).

Basilea’s ceftobiprole phase 3 program 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. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the phase 3 studies in SAB and acute bacterial skin and skin structure infections (ABSSSI), regulatory activities and non-clinical work.

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