Basilea Pharmaceutica AG's antibiotic worked as well as vancomycin plus aztreonam in treating an acute skin infection during a late-stage study.
Basel, Switzerland-based Basilea was evaluating ceftobiprole against vancomycin plus aztreonam in a phase 3 study called Target to treat patients with acute bacterial skin and skin structure infections, or ABSSSI. The infections are caused by gram-negative and gram-positive bacteria.
The study included 679 patients who were randomized to receive ceftobiprole three times daily or 1,000 milligrams each of vancomycin and aztreonam twice-daily. Vancomycin is the standard of care antibiotic in hospitalized patients with gram-positive infections. Aztreonam, sold under the brand name Azactam among others, is an antibiotic used primarily to treat infections caused by gram-negative bacteria.
Results showed that 91.3% of patients who received ceftobiprole saw a 20% or more reduction in lesion size at 48 to 72 hours after initiating treatment, compared to 88.1% of patients who received vancomycin plus aztreonam. In addition, ceftobiprole resolved signs and symptoms of the infection in 90.1% of patients, compared to 89% receiving the standard treatment 15 to 22 days after initiation.
Target is the first of two phase 3 trials being conducted under special protocol assessment agreements with the U.S. Food and Drug Administration. A second study, named Eradicate, is comparing ceftobiprole and daptomycin with or without aztreonam to treat patients with Staphylococcus aureus bacteremia, a leading cause of bloodstream infections. Top-line results from the ongoing study are expected in the second half of 2021. The company is undertaking the studies as a requirement to file a new drug application for ceftobiprole in the U.S.
Basilea was granted a qualified infectious disease product designation from the FDA for ceftobiprole to treat these diseases, which will allow the drug to receive 10 years of market exclusivity in the U.S. if approved.