Basilea Pharmaceutica Ltd. announced that the ceftobiprole phase III top-line study results in hospital-acquired pneumonia (HAP) met the primary endpoint of non-inferiority versus combination therapy of ceftazidime plus linezolid.
A company press release stated that Ceftobiprole is the first anti-MRSA (methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin to complete phase III clinical trials and is being co-developed with Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
The study compared clinical outcomes following the treatment with either ceftobiprole monotherapy or combination therapy of ceftazidime plus linezolid in patients with HAP including a subgroup of patients with microbiologically and clinically more complex ventilator-associated pneumonia (VAP). This trial is the consolidated protocol from two former HAP trials.
Overall, 69 per cent of the clinically evaluable (CE) patients were cured with ceftobiprole compared to 72 per cent of patients treated with combination therapy. The study met the non-inferiority criteria in both CE and intent-to-treat populations, the report said.
In the CE patient population excluding VAP clinical cure rates were 77 per cent for ceftobiprole and 76 per cent for combination therapy.
Cure rates in the smaller VAP patient subset (about 25 per cent of patients enrolled) were lower for ceftobiprole treated patients and non-inferiority could not be established. Further analyses are ongoing.
Ceftobiprole was generally well tolerated. The rate of overall adverse events was comparable between the two treatment groups. The adverse event profile of ceftobiprole was consistent with previous phase III studies and that of the cephalosporin class, the company said.
"We are delighted with the preliminary results of this hospital-acquired pneumonia trial. According to recent publications, community-acquired pneumonia (CAP) and non-ventilator-associated pneumonia account for up to 90 per cent of pneumonia patients in the hospital setting. The results of this study together with the recently announced positive top-line results from the trial in CAP requiring hospitalisation will form the basis of further regulatory submissions" commented Dr Anthony Man, CEO, 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.
Pneumonia is one of the leading causes of hospitalisation and mortality. A recent survey of a large US database indicates that of all hospitalised patients with pneumonia approximately 70 per cent had community-acquired and/or healthcare-associated pneumonia. HAP and VAP accounted for a roughly 20 per cent and 10 per cent, respectively, of the population and MRSA was present in 9 per cent to 25 per cent of cases of pneumonia
Ceftobiprole (BAL5788), 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, the company statement said.
Ceftobiprole is being developed through an exclusive worldwide collaboration between Basilea Pharmaceutica Ltd. and Cilag GmbH International. Ortho-McNeil, Inc., will market ceftobiprole in the U.S. and Janssen-Cilag companies will market the product in Europe and Asia. Basilea has exercised its co-promotion rights for ceftobiprole in North America and major European countries, and maintains an option to co-promote the drug in Japan and China.
Basilea Pharmaceutica Ltd. is an integrated biopharmaceutical company headquartered in Basel, Switzerland, with focus on the discovery, development and commercialisation of innovative medicines to satisfy high medical and patient needs in the hospital and specialty pharmaceutical setting. Basilea has a diversified product portfolio including novel treatments for resistant bacterial infections, systemic fungal infections and severe skin diseases.