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news.Basilea Pharmaceutica has said a second phase III study of ceftobiprole in complicated skin infections has met its primary endpoint and has shown anti-MRSA activity.
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The primary endpoint of the trial was statistical non-inferiority versus combination therapy. Ceftobiprole demonstrated high cure rates in patients with skin infections including diabetic patients with foot infections.
In this study 91% of patients were cured with ceftobiprole compared to 90% of patients treated with combination therapy. The clinical response in patients with diabetic foot infections was 86% for ceftobiprole and 82% for comparator combination therapy, respectively. These results show that ceftobiprole monotherapy is superior to standard combination therapy.
Ceftobiprole is an anti-MRSA, broad-spectrum cephalosporin developed in collaboration with Cilag GmbH International, a Johnson & Johnson company. A first regulatory submission for Ceftobiprole is planned this year.
Complicated skin and skin structure infections are among the most common infections in the hospital setting. In recent years resistant strains such as MRSA have become increasingly common and have been associated with increased morbidity and mortality.