Basilea says ceftobiprole shows high cure rate in phase 3 trial

By Ted A. Knutson

Washington, March 2 - Basilea Pharmaceutica Ltd. said Thursday the first comparative phase 3 trial of ceftobiprole showed a high cure rate and was safe and well tolerated.

This first-in-class anti-MRSA broad-spectrum cephalosporin is partnered with Cilag AG International, a Johnson & Johnson company. Methicillin-resistant Staphylococcus aureus (MRSA) is a major cause of mortality and morbidity in severe hospital infections.

"These exciting results are a very important and a positive step forward for Basilea and our partner, Cilag AG International. Ceftobiprole has performed consistently in line with our expectations to date. This positive trial is the first of a series of ongoing registration studies designed to demonstrate the effectiveness of ceftobiprole," said Dr. Anthony Man, Basilea's chief executive officer, in a press release.

"Our goal is to bring this product to market as soon as possible because patients with serious hospital infections are in need of new treatment options."

In the phase 3 study targeting Gram-positive infections, 397 patients were treated with 500 mg ceftobiprole and 387 patients with 1 g vancomycin; both groups were treated twice daily for seven to 14 days. 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 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.

Basilea is a Basel, Switzerland-based biotech company.

© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere. For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.