Basilea updates on ceftobiprole and BAL101553 development

Swiss drugmaker Basilea Pharmaceutica (SIX: BSLN) has provided an update on the planned clinical Phase III development program for its antibiotic ceftobiprole in the USA and reported completion of patient recruitment and interim data from the ongoing Phase I/IIa study with the intravenous formulation of its oncology drug candidate BAL101553.

Following recent discussions with the Food and Drug Administration, Basilea will consider conducting cross-supportive clinical studies for the indications of acute bacterial skin and skin structure infections, community-acquired bacterial pneumonia and Staphylococcus aureus bloodstream infections, or bacteremia, including endocarditis. Basilea currently expects that it would not initiate Phase III studies until such time as it has entered into a collaboration agreement with a third party.

Basilea is now preparing Phase III study protocols for submission to the FDA in the first quarter of 2016, seeking Special Protocol Assessments (SPAs). An SPA provides written guidance by the FDA and documents agreement between the study sponsor and the agency that a clinical study is adequately designed so that it would support a regulatory submission for drug approval, should the study meet its objectives.