Basel, Switzerland, February 23, 2018 Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today that it has commenced enrollment in the first of its two planned clinical phase 3 registration studies of the antibiotic ceftobiprole. The first study evaluates the safety and efficacy of the antibiotic in the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI). Basilea expects to begin enrollment in the second phase 3 clinical trial of ceftobiprole in the treatment of adult patients with bacteremia (bloodstream infection) caused by Staphylococcus aureus mid-2018. The two trials are designed to be cross-supportive for a potential U.S. registration and are conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).
Ronald Scott, Chief Executive Officer, said: "We are pleased to have commenced enrollment of the phase 3 ABSSSI program for ceftobiprole with the goal to bring our broad-spectrum anti-MRSA antibiotic to patients in the U.S. Acute bacterial skin and skin structure infections are among the most common bacterial infections encountered in both community and hospital settings. Skin infections caused by resistant bacteria such as MRSA have become a challenging medical problem associated with extended hospitalization, high costs and increased mortality. Ceftobiprole offers a potential treatment option in an area of high medical need."
The randomized, double-blind, multicenter study aims to establish the safety and efficacy of intravenously (i.v.) administered ceftobiprole versus i.v. vancomycin (plus aztreonam for Gram-negative infections) in the treatment of ABSSSI. The FDA-agreed primary objective of the study is to demonstrate non-inferiority of ceftobiprole to the comparator regimen with respect to early clinical response based on reduction of lesion size. The study is anticipated to enroll approximately 675 male and female adult patients.
Basilea's phase 3 ceftobiprole program is being conducted under a contract with the U.S. Biomedical Advanced Research and Development Authority (BARDA) which provides funding of up to USD 108 million.