Basilea's ceftobiprole meets Ph II endpoint

Swiss drugmaker Basilea Pharmaceutica says that its developmental antibiotic ceftobiprole has met its primary endpoint of non-inferiority to combination therapy in a second pivotal Phase III trial assessing it as a treatment for complicated skin infections. The company said that the drug is a broad-spectrum cephalosporin, developed in collaboration with Johnson & Johnson's Cilag GmbH unit.

Basilea reported that, in the study, the agent had conferred a total cure in 90% of patients with gram positive and gram negative infections, including diabetic patients with foot infections, in comparison with the 82% cure rate achieved by those treated with standard combination vancomycin plus ceftazidime therapy. The company added that the clinical cure rate for methicillin-resistant Staphylococcus aureus was 91%, versus 81% for the comparator regimen. The firm also said that the drug was well tolerated, and that adverse events were comparable between both groups.

Basilea's chief executive, Anthony Man, said that the drug, which has been designated for fast-track review by the US Food and Drug Administration, had achieved significant progress and was on track for regulatory filing later this year.