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
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.
For further information please visit idweek.org.
Ceftobiprole medocaril, the prodrug of the active moiety ceftobiprole, is a cephalosporin antibiotic for intravenous administration, with rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. This includes methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp.3 The brand is currently approved and marketed as Zevtera and Mabelio in a number of countries in Europe and beyond for the treatment of adult patients with hospital-acquired bacterial pneumonia (HABP), excluding ventilator-associated bacterial pneumonia (VABP), and for the treatment of community-acquired bacterial pneumonia (CABP). Basilea has entered into license and distribution agreements in Europe, Eurasian countries, Latin America, China, Canada, Israel, and the Middle East and North Africa (MENA) regions.
About the ceftobiprole phase 3 program
The ERADICATE study1 was a randomized, double-blind, multicenter phase 3 study, which enrolled 390 patients with SAB. The study compared the safety and efficacy of intravenous ceftobiprole medocaril with intravenous daptomycin, with or without intravenous aztreonam for coverage of Gram-negative pathogens, for up to 42 days of treatment. Patients were enrolled at more than 50 study centers in Eastern and Central Europe, Israel, Latin America, the Republic of South Africa, and the U.S.
The second study of the program, the TARGET study4, was a randomized, double-blind, multicenter phase 3 study, which enrolled 679 patients with acute bacterial skin and skin structure infections (ABSSSI) and compared the safety and efficacy of intravenous ceftobiprole medocaril with intravenous vancomycin plus intravenous aztreonam. The study was conducted at more than 30 clinical centers in the U.S. and Europe.
The two phase 3 studies were conducted under Special Protocol Assessment (SPA) agreements with the U.S. FDA.
Basilea’s ceftobiprole phase 3 program is funded in part (up to USD 136.4 million, which is approximately 70% of the total potential program costs) with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C.
About Staphylococcus aureus bacteremia (SAB)
Staphylococcus aureus bacteremia is a leading cause of bloodstream infections, responsible for a broad variety of complications and has been associated with significant morbidity and a mortality of 20 to 40%.5, 6 Several studies have demonstrated that MRSA bacteremia is associated with a significantly higher mortality rate compared with MSSA bacteremia.7, 8 Infections of the inner lining of the heart or heart valves (infective endocarditis) and bone infections (osteomyelitis) are common complications of SAB.
Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have several preclinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com.
This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
For further information, please contact:
Peer Nils Schröder, PhD
+41 61 606 1102
This press release can be downloaded from www.basilea.com.
ERADICATE: ClinicalTrials.gov identifier NCT03138733
K. Hamed, M. Engelhardt, M. E. Jones et al. Ceftobiprole versus daptomycin in Staphylococcus aureus bacteremia: a novel protocol for a double-blind, Phase III trial. Future Microbiology. 2020 (1), 35-48
Basilea ad hoc announcement: Basilea announces positive results of phase 3 ERADICATE study with ceftobiprole in Staphylococcus aureus bacteremia (SAB). June 28, 2022: https://www.basilea.com/news#news_1371
Summary of Product Characteristics (SmPC) Zevtera: https://www.medicines.org.uk/emc/product/9164/smpc [Accessed: October 12, 2022]
TARGET: ClinicalTrials.gov identifier NCT03137173
J. S. Overcash, C. Kim, R. Keech R et al. Ceftobiprole Compared With Vancomycin Plus Aztreonam in the Treatment of Acute Bacterial Skin and Skin Structure Infections: Results of a Phase 3, Randomized, Double-blind Trial (TARGET). Clinical Infectious Diseases 2021 (73), e1507-e1517
A. G. Jensen, C. H. Wachmann, F. Espersen et al. Treatment and outcome of Staphylococcus aureus bacteremia: a prospective study of 278 cases. Archives of Internal Medicine 2002 (162), 25-32
J.-L. Wang, S.-Y. Chen, J.-T. Wang et al. Comparison of both clinical features and mortality risk associated with bacteremia due to community-acquired methicillin-resistant Staphylococcus aureus and methicillin-susceptible S. aureus. Clinical Infectious Diseases 2008 (46), 799-806
S. I. Blot, K. H. Vandewoude, E. A. Hoste et al. Outcome and attributable mortality in critically ill patients with bacteremia involving methicillin-susceptible and methicillin-resistant Staphylococcus aureus. Archives of Internal Medicine 2002 (162), 2229-2235
S. E. Cosgrove, G. Sakoulas, E. N. Perencevich et al. Comparison of mortality associated with methicillin-resistant and methicillin-susceptible Staphylococcus aureus bacteremia: a meta-analysis. Clinical Infectious Diseases 2003 (36), 53-59