Basilea Pharmaceutica Ltd. unveiled positive Phase III results for ceftobiprole in Staphylococcus aureus bacteremia (SAB), on top of existing Phase III data for the drug in acute bacterial skin and skin structure infection (ABSSSI). The company is looking to partner the product for the US market and hoping that differentiation from existing treatments can help it succeed where other new anti-infectives have failed.
The Phase III ERADICATE trial compared intravenous ceftobiprole against intravenous daptomycin with or without aztreonam in 390 patients with complicated SAB, including right-side endocarditis. The Swiss biotech already had positive results from the Phase III TARGET trial in 679 patients with ABSSSI, which completed in 2019. Based on the results of the two trials, the company plans to file for US Food and Drug Administration approval of ceftobiprole around the end of 2022