“Basilea reports clinical phase 3 study start with antibiotic ceftobiprole in skin infections under BARDA contract”
“Basilea Pharmaceutica Ltd. (SIX: BSLN) announced 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).”
Source: Financial Buzz
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