BioVersys Gets FDA Nod for BV100 Phase 3 Trial for Pneumonia

BioVersys AG, a clinical stage biopharmaceutical company, announced US FDA approval for a pivotal Phase 3 trial of BV100. The trial targets hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii (CRAB). The BV100 formulation is designed to tackle multi-drug resistant infections.

The Phase 3 trial will evaluate BV100 with polymyxin B in 300 patients across two arms, with a focus on 28-day all-cause mortality. Part B will assess BV100 in patients resistant to colistin and polymyxin B. The trial mimics a successful Phase 2 study, with a read-out expected by the end of 2027.

CEO Marc Gitzinger emphasized the significance of enrolling US patients and the pivotal role this trial plays in offering new treatment options for critical infections.