BASILEA announces positive results of Phase IIII study into SAB treatment
pharmafile | June 28, 2022 | News story | Manufacturing and Production |
Basilea Pharmaceutica has announced positive topline results for the Phase III ERADICATE study, evaluating ceftobiprole in the treatment of adult patients with bacterial bloodstream infections caused by Staphylococcus aureus (SAB).
Basilea is planning to submit an NDA for ceftobiprole to the FDA by the end of the year.
In accordance with the agreed Special Protocol Assessment (SPA), Basilea will seek approval for SAB and acute bacterial skin and skin structure infection (ABSSSI) indications, based on the successfully completed ERADICATE study and the TARGET Phase III study, which was successfully completed in patients with ABSSSI in 2019. The ERADICATE study enrolled 390 patients with complicated SAB, including right-sided endocarditis.
Dr Marc Engelhardt, CMO, stated: “The successful completion of the ERADICATE study is an exceptional achievement. ERADICATE is the largest double-blinded randomised study conducted of a new antibiotic treatment in SAB. The positive results underline the potent activity of ceftobiprole for treating serious bacterial infections.
“Achieving this important milestone enables us to proceed with a regulatory filing. Ceftobiprole would be the first beta-lactam antibiotic approved in the US for the treatment of SAB caused by methicillin-susceptible or methicillin-resistant strains of Staphylococcus aureus, addressing important medical needs.”
Thomas Holland, MD, Associate Professor of Medicine at Duke University School of Medicine and chair of the ERADICATE Data Review Committee said: “This is a landmark study in an area with a high need to provide new treatments to patients. Complicated Staphylococcus aureus bloodstream infections are common and associated with high morbidity and significant mortality and available antibiotic treatment options are limited, especially when methicillin-resistant Staphylococcus aureus is involved. The ERADICATE study provides strong support for the efficacy and safety of ceftobiprole in complicated SAB. This large Phase III study included patients with a wide spectrum of underlying complications, underscoring its broad applicability to routine clinical practice.”
Lina Adams
