Ceftobiprole enters Phase III study for the treatment of patients with bacteremia (bloodstream infections) caused by Staphylococcus aureus.- Basilea Pharma.

Basilea Pharmaceutica Ltd. has announced the start of a clinical phase III study with its antibiotic ceftobiprole. The registration study evaluates the safety and efficacy of ceftobiprole in the treatment of patients with bacteremia (bloodstream infections) caused by Staphylococcus aureus.

David Veitch, Chief Executive Officer, said: �We are very pleased to have started the SAB study. This is the second of our two phase III studies that are required to potentially gain a U.S. marketing authorization. SAB and associated complications cause significant morbidity and mortality, in particular if caused by methicillin-resistant Staphylococcus aureus, MRSA. With its broad spectrum of activity, including MRSA, ceftobiprole has the potential to become an important treatment option for patients with these serious hospital bacterial infections.�

The randomized, double-blind, multi-center study aims to establish the safety and efficacy of intravenously (i.v.) administered ceftobiprole versus i.v. daptomycin (plus optional aztreonam for Gram-negative infections) in the treatment of SAB. The FDA-agreed primary endpoint is to demonstrate non-inferiority of ceftobiprole to the comparator regimen at the post-treatment evaluation visit 70 days after randomization. The study is anticipated to enroll approximately 390 adult patients. Additional information on this clinical study is available at www.clinicaltrials.gov (identifier: NCT03138733).

A first phase III study was started in February which evaluates ceftobiprole in the treatment of acute bacterial skin and skin structure infections (ABSSSI). The two phase III studies are designed to be cross-supportive for a potential U.S. registration and are conducted under a Special Protocol Assessment (SPA) agreement with the FDA. Basilea�s ceftobiprole phase 3 program is funded in part (up to USD 118 million, which is approximately 70% of the total estimated program costs) with Federal funds from the U.S. Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201600002C.