Basilea Announces Positive Top-line Data from Phase III Study of Ceftobiprole in Hospital-Acquired Pneumonia
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. 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% of the clinically evaluable (CE) patients were cured with ceftobiprole compared to 72% of patients treated with combination therapy. The study met the non-inferiority criteria in both CE and intent-to-treat populations. In the CE patient population excluding VAP clinical cure rates were 77% for ceftobiprole and 76% for combination therapy.
Cure rates in the smaller VAP patient subset (about 25% 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.
Ceftobiprole is currently under review by regulatory authorities in the U.S., Europe and Canada for the treatment of complicated skin and skin structure infections.
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