Basilea Pharmaceutica Ltd. has announced that the ceftobiprole phase III top-line study results in community-acquired pneumonia (CAP) patients requiring hospitalization met the primary endpoint of non-inferiority versus the study comparators.

Ceftobiprole is the first anti-MRSA (methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin under evaluation for marketing authorization and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.

The study compared clinical outcomes following the treatment with ceftobiprole versus ceftriaxone with or without linezolid in patients hospitalized with community-acquired pneumonia. The clinical cure rate at the test-of-cure (TOC) visit in the clinically evaluable population was 86 per cent for ceftobiprole and 87 per cent for the comparators.

The microbiological eradication rates were 88 per cent and 92 per cent in the ceftobiprole and comparator arm, respectively. The clinical cure rate in the clinically evaluable patient population with moderate to severe pneumonia (defined as a score >90 on the PORT pneumonia severity index) was 89 per cent and 81 per cent for the ceftobiprole and comparator arms, respectively.

Ceftobiprole was generally well tolerated, with an adverse event profile consistent with that previously reported.

"We are delighted with these clinical results that show that ceftobiprole was as effective as the comparator regimen in these respiratory infections that were severe enough to require hospitalization. We believe that ceftobiprole may have the potential to become a useful therapeutic option to treat patients with community-acquired pneumonia, in particular in patients who require a broader antibiotic coverage", commented Dr Anthony Man, CEO of Basilea.

Ceftobiprole is currently under review by Regulatory Authorities in the US, Europe and Canada for the treatment of complicated skin and skin structure infections.

Ceftobiprole, Basilea's lead antibacterial product, is the first of a new class of anti-MRSA broad-spectrum cephalosporin antibiotics. It is specially designed to inhibit penicillin-resistant targets in many Gram-positive cocci, resulting in potent bactericidal activity towards MRSA and penicillin-resistant Streptococcus pneumoniae (PRSP). In clinical trials, ceftobiprole has demonstrated a broad-spectrum profile targeting other Gram-positive and Gram-negative pathogens. In addition, it has shown a low potential to select resistance in vitro. In the trials, ceftobiprole was generally well tolerated with a safety profile consistent with the cephalosporin class of antibiotics.