Basilea’s MRSA drug performs well in late-stage trial

Ceftobiprole showed a high cure rate and was safe and well tolerated. This first-in-class anti-MRSA broad-spectrum cephalosporin is being developed in partnership with Cilag AG International, a Johnson & Johnson company.

The phase III study, named Strauss, demonstrated a high cure rate. In this study targeting Gram-positive infections, 397 patients were treated with 500mg ceftobiprole and 387 patients with 1g vancomycin. Both groups were treated twice daily for one week to two weeks.

Statistical non-inferiority was achieved with 93.3% of patients clinically cured on ceftobiprole, and 93.5% of patients treated with vancomycin. Over 25% of microbiologically evaluable patients were confirmed with MRSA (methicillin-resistant staphylococcus aureus) infections. The ceftobiprole response rate in infections caused by MRSA was 91.9% compared with 90.0% for vancomycin. Adverse events were comparable between the two treatment groups.

“MRSA is a major cause of mortality and morbidity in severe hospital infections and is of increasing concern in the community. While ceftobiprole has a broad spectrum of activity, this study was specifically designed to highlight the gram-positive activity, including MRSA,” said Dr Rienk Pypstra, chief development officer of Basilea.

Shares in Basilea rose 10.5% to 184.50 Swiss francs on the news.