Positive results of phase III ERADICATE study with ceftobiprole in Staphylococcus aureus bacteremia (SAB).- Basilea Pharmaceutica
Basilea Pharmaceutica Ltd announced today 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).
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 II study, which was successfully completed in patients with ABSSSI in 2019.
In addition, the company will explore the possibility for gaining approval for a third indication based on a previously performed phase III study in community-acquired bacterial pneumonia (CABP).
The ERADICATE study enrolled 390 patients with complicated SAB, including right-sided endocarditis. Ceftobiprole met the pre-specified efficacy objective of overall success in the modified intent-to-treat (mITT) population at 70 days after randomization, assessed by an independent Data Review Committee, within the pre-specified non-inferiority margin of 15% compared to daptomycin, with or without aztreonam. The overall success rate was 69.8% with ceftobiprole compared to 68.7% with daptomycin, with or without aztreonam. The statistically adjusted difference between ceftobiprole and the comparator group was 2.0% (95% confidence interval: -7.1% to 11.1%). Initial subgroup analyses showed no significant differences between the two treatment groups.
Ceftobiprole was well tolerated and the observed safety profile was consistent with previous phase III studies and the post-marketing experience with ceftobiprole. In the ERADICATE study the overall rate of adverse events was similar between the two treatment groups. As expected, gastrointestinal side effects were more frequent with ceftobiprole.
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