Basilea jumps on positive Ph III for antibiotic ceftobiprole

Basilea Pharmaceutica (SIX: BSLN) today announced positive top-line results for the Phase III TARGET study, evaluating ceftobiprole in the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI), with the news sending the Swiss biotech firm’s shares up 8.78% to 37.92 Swiss francs by early afternoon trading.

Ceftobiprole met the primary endpoint of non-inferiority within the pre-specified margin of 10%: 91.3% of patients achieved an early clinical response versus 88.1% in the comparator arm. The drug also met the two secondary endpoints of clinical success at the test-of-cure (TOC) visit 15 to 22 days after randomization in both the intent-to-treat (ITT) population (90.1% versus 89.0%) and the clinically evaluable (CE) group (97.9% versus 95.2%).

Dr Marc Engelhardt, chief medical officer, stated: "The successful completion and positive results of our Phase III study in skin infections marks the achievement of a significant milestone towards a filing of ceftobiprole in the US. The second study, in Staphylococcus aureus bloodstream infections, is well on track and is expected to deliver top-line results in the second half of 2021. In both indications, ceftobiprole addresses unmet medical needs through its broad-spectrum rapid bactericidal activity, with the ability to cover both Gram-positive and Gram-negative pathogens and with the well-established safety profile of a cephalosporin."