HQ Team
September 28, 2023: Swiss biotechnology company, Basilea Pharmaceutica’s last stage trials of ceftobiprole to treat bacterial bloodstream infections have shown favourable outcomes, according to a statement.
The experimental study on adult patients with Staphylococcus aureus (SAB) infections showed similar clinical benefits compared to daptomycin, which is a standard-of-care antibiotic in the treatment.
The study was conducted on 390 adult patients with complicated infections at 60 sites in 17 countries.
Patients were randomised to receive infusions of ceftobiprole or daptomycin — plus optional aztreonam — for up to 42 days Randomisation is the process when each of patient treatment is based on chance, rather than decided by the doctor or participant.
“The primary outcome of the study was overall treatment success at 70 days after randomization defined by survival, bacteremia clearance, symptom improvement, no new SAB-related complications, and no receipt of other potentially effective antibiotics,” the company stated.
‘Well tolerated’
The treatment with ceftobiprole was “non-inferior” to daptomycin with overall treatment success achieved in 69.8% of patients in the ceftobiprole group compared to 68.7% in the daptomycin group.
Ceftobiprole was generally well tolerated and showed a safety profile consistent with previous phase 3 studies and the post-marketing experience.
“This is an area with a high need to provide new treatments to patients and there has not been a new antibiotic approved for the treatment of Staphylococcus aureus bacteremia for over 15 years,” said Thomas Holland, associate professor in the Department of Medicine at Duke University School of Medicine and chair of the data review committee of the study.
Ceftobiprole, branded by the company as Zevtera and Mabelio, has been approved in several countries in Europe. Basilea has entered into license and distribution agreements covering more than 80 countries. Ceftobiprole is currently not approved or partnered in the US.
“Complicated Staphylococcus aureus infections have a high mortality rate,” said Vance G. Fowler, Jr., Professor in the Department of Medicine and Molecular Genetics & Microbiology at Duke University School of Medicine and academic lead investigator.
The infections “are associated with substantial morbidity and we need more options for treating these infections,” especially if methicillin-resistant Staphylococcus aureus is involved, he said.
