Basilea, JNJ start ceftobiprole Phase III

Basilea (SWX:BSLN) and Johnson & Johnson (JNJ) started an international, double-blind, active-controlled Phase III trial of ceftobiprole ( BAL5788) in 670 patients with community-acquired pneumonia (CAP) that require hospitalization. The primary endpoint is clinical cure rate seven to 14 days after the end of therapy. The active control is undisclosed.

Ceftobiprole has completed the Phase III STRAUSS 1 trial to treat Gram-positive complicated skin and skin structure infections (cSSSIs) and is also in a Phase III trial for Gram-positive and -negative cSSSIs and another for hospital-acquired pneumonia. The broad spectrum anti-MRSA cephalosporin antibiotic that inhibits penicillin-binding proteins (PBPs) has Fast Track designation for cSSSIs and hospital-acquired pneumonia. BSLN expects to submit an NDA next year. ...