2023-09-28 07:22:50
Basilea Pharmaceutica AG Announces Positive Data from Phase 3 ERADICATE Study Published in New England Journal of Medicine
Allschwil, September 28, 2023 – Basilea Pharmaceutica AG (SIX: BSLN), a biopharmaceutical company focused on helping patients with serious bacterial or fungal infections, has announced that data from its Phase 3 ERADICATE study has been published in the prestigious New England Journal of Medicine (NEJM). The study evaluated the efficacy of Basilea’s ceftobiprole, a beta-lactam antibiotic, in the treatment of Staphylococcus-aureus Bacteremia (SAB) in adult patients.
The ERADICATE study was a double-blind, non-inferiority trial that enrolled 390 adult patients with complicated SAB at 60 study sites in 17 countries. Patients were randomly assigned to receive either ceftobiprole or daptomycin, a standard antibiotic for the treatment of SAB, for up to 42 days. The study’s primary endpoint was treatment success 70 days after randomization, defined as survival, elimination of the Staphylococcus aureus bacteremia, symptom improvement, absence of new complications, and no need for additional antibiotics.
The results of the study showed that ceftobiprole was non-inferior to daptomycin, with an overall success rate of 69.8% in the ceftobiprole group compared to 68.7% in the daptomycin group. The success rate was consistent in key subgroups, including patients with methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-sensitive Staphylococcus aureus (MSSA) infections. Ceftobiprole also demonstrated high efficacy in eliminating MRSA and MSSA bacteria from the circulation.
The safety profile of ceftobiprole was consistent with previous phase 3 studies and experience with the antibiotic. Adverse events were similar in both treatment groups, with more gastrointestinal side effects reported in the ceftobiprole group. Importantly, there were no reports of infections caused by Clostridioides difficile in either group.
The publication of the ERADICATE study results in NEJM highlights the clinical benefit of ceftobiprole in the treatment of serious bacterial infections. Basilea has recently submitted an application for the approval of ceftobiprole to the US Food and Drug Administration for three indications: Staphylococcus-aureus Bacteremia, acute bacterial skin and soft tissue infections, and community-acquired bacterial pneumonia.
Dr. Thomas Holland, Associate Professor in the Department of Medicine at Duke University School of Medicine and Chair of the study’s Data Review Committee, emphasized the need for new therapies for patients with Staphylococcus-aureus Bacteremia. Dr. Vance G. Fowler Jr., Professor in the Department of Medicine and Molecular Genetics & Microbiology at Duke University School of Medicine and Academic Lead Investigator, highlighted the high mortality rate and significant morbidity associated with complicated Staphylococcus-aureus Infections, especially when MRSA is involved.
Dr. Marc Engelhardt, Chief Medical Officer of Basilea, expressed his satisfaction with the study results and the effectiveness of ceftobiprole in serious bacterial infections. He also mentioned that the Phase 3 ceftobiprole program is funded in part by federal funds from the U.S. Department of Health and Human Services.
Ceftobiprole is already approved and on the market in numerous countries under the brand names Zevtera and Mabelio for the treatment of adult patients with hospital-acquired or community-acquired bacterial pneumonia. Basilea has entered into licensing and distribution partnerships for ceftobiprole in over 80 countries. The antibiotic is classified as a Qualified Infectious Disease Product (QIDP) by the US FDA for various indications, granting it 10 years of market exclusivity if approved.
Basilea Pharmaceutica AG was founded in 2000 and is focused on discovering, developing, and commercializing innovative medicines for serious bacterial or fungal infections. The company has successfully brought two medications, Cresemba and Zevtera, to the market for the treatment of invasive fungal and bacterial infections, respectively.
For further information, please visit www.basilea.com.
Source:
– T. L. Holland, S. E. Cosgrove, S. B. Doernberg et al. Ceftobiprole for treatment of complicated Staphylococcus aureus bacteremia. New England Journal of Medicine 2023 Sep 27; DOI: 10.1056/NEJMoa2300220. Epub ahead of print.
– ERADICATE: ClinicalTrials.gov Identifier NCT03138733
– Summary of Product Characteristics (SmPC) Zevtera]
#Basilea #Announces #Publication #Phase #Data #Ceftobiprole #Treatment #Staphylococcus #aureus #Bacteremia #England #Journal #Medicine