Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today positive topline results for the phase 3 TARGET study, evaluating ceftobiprole in the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).
Dr. Marc Engelhardt, Chief Medical Officer, stated: "The successful completion and positive results of our phase 3 study in skin infections marks the achievement of a significant milestone towards a filing of ceftobiprole in the U.S. The second study, in Staphylococcus aureus bloodstream infections, is well on track and is expected to deliver topline 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."
If both studies are positive, Basilea plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). As ceftobiprole was designated a Qualified Infectious Disease Product (QIDP) by the FDA for these indications, if approved, ceftobiprole will be eligible to receive ten years of market exclusivity in the U.S. from the date of approval.
The TARGET study enrolled 679 patients. Ceftobiprole met the pre-specified primary efficacy objective of non-inferiority (within the pre-specified margin of 10%) to vancomycin plus aztreonam in the intent-to-treat (ITT) population. The primary endpoint of early clinical response was based on a 20% or more reduction from baseline in lesion size at 48 to 72 hours after start of study drug administration. In addition, ceftobiprole was also non-inferior to vancomycin plus aztreonam for the pre-specified secondary endpoint of investigator-assessed clinical success, which was based on resolution of baseline signs and symptoms of the infection, in the ITT and the clinically evaluable (CE) patient populations at the test-of-cure (TOC) visit, 15 to 22 days after randomization.