Sparks - BioVersys

BioVersys has announced that it has received regulatory clearance from the FDA for its Investigational New Drug application supporting the registrational global Phase III (RIV-TARGET) trial for its lead asset BV100.  The study will evaluate BV100 in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii (CRAB).

The pivotal study is designed as a randomised, active-controlled, two-part parallel-group trial targeting c 300 patients. Participants will be randomised 1:1 to receive either BV100 plus low-dose polymyxin B or a standard-of-care regimen of colistin plus high-dose ampicillin-sulbactam, with meropenem permitted as background therapy in cases of polymicrobial infection. The primary endpoint is 28-day all-cause mortality. The design broadly mirrors the earlier Phase II study, where BV100 demonstrated a meaningful survival signal versus best available therapy (25% vs 60% mortality in confirmed VABP CRAB patients). The trial also includes an open-label, non-randomised cohort (Part B) evaluating BV100 plus low-dose polymyxin B in treatment-refractory patients, including those with CRAB infections resistant to polymyxins or where prior polymyxin-based therapy has failed. Around 25 patients are expected to be enrolled in this cohort.

BV100 is an intravenous formulation of rifabutin designed to enable intracellular uptake in gram-negative pathogens, potentially addressing one of the key resistance barriers in Acinetobacter baumannii. The asset also carries Qualified Infectious Disease Product designation, supporting priority review and extended market exclusivity (an additional five years, which extends market protection to 2045), if approved. The Phase III readout is expected by end-2027, with potential regulatory filings in 2028.