- First presentation of ERADICATE phase 3 study data
- Study met its primary and secondary endpoints comparing ceftobiprole versus daptomycin with or without aztreonam
Basel/Allschwil, Switzerland, October 13, 2022
Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that an abstract on the successfully completed phase 3 ERADICATE study1, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus, (SAB), has been selected for a late breaking oral presentation at IDWeek 2022. The ERADICATE data will be presented by Thomas Holland, M.D., Associate Professor of Medicine at Duke University School of Medicine and Chair of the ERADICATE Data Review Committee.
IDWeek is the annual meeting of the Infectious Diseases Society of America (IDSA), jointly held with other infectious diseases societies in the U.S. and will take place in Washington, D.C. from 19 to 23 October 2022.
Positive topline results of the ERADICATE study, demonstrating non-inferiority to daptomycin, with or without aztreonam, for the primary objective, had been reported in June 2022.2
Dr. Marc Engelhardt, Chief Medical Officer, said: “This will be the first comprehensive presentation of the phase 3 ERADICATE study data. The study is the largest double-blind randomized study of a new antibiotic treatment conducted in SAB, which remains an area of high unmet medical need with limited treatment options available. The positive results underline the potent activity of ceftobiprole for treating serious bacterial infections and enable us to proceed with an NDA submission of ceftobiprole in the U.S.”
Basilea is planning to submit a New Drug Application (NDA) for ceftobiprole to the U.S. Food and Drug Administration (FDA) around year-end 2022.
Ceftobiprole at IDWeek 2022
22 October 2022, 1:45 p.m. ET (19:45 CEST)
Late Breaking Clinical Trials
LB2302 – Ceftobiprole Compared to Daptomycin With or Without Optional Aztreonam for the Treatment of Complicated Staphylococcus aureus Bacteremia (SAB): Results of a Phase 3, Randomized, Double-Blind Trial (ERADICATE) – Thomas L. Holland, Sara E. Cosgrove, Sarah B. Doernberg, Oleksandr Pavlov, Ivan Titov, Boiko Atanasov, Maziar Assadi Gehr, Marc Engelhardt, Kamal Hamed, Daniel Ionescu, Mark Jones, Mikael Saulay, Jennifer Smart, Harald Seifert, Timothy C. Jenkins, Nicholas A. Turner, Vance G. Fowler Jr.
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