The FDA has confirmed U.S. patient enrollment for BioVersys’ Phase 3 RIV-TARGET trial evaluating BV100, an intravenous rifabutin formulation, for hospital-acquired and ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
BioVersys AG announced that the U.S. Food and Drug Administration has confirmed that U.S. patient enrollment can proceed in the global Phase 3 RIV-TARGET trial evaluating BV100 for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The regulatory clearance allows U.S. clinical sites to begin recruiting patients as part of the ongoing global pivotal study.
CRABC is considered one of the most dangerous multidrug-resistant Gram-negative pathogens and has been designated a critical priority by global health authorities. BioVersys is developing BV100, an optimized intravenous formulation of rifabutin designed to exploit a newly identified active uptake mechanism in Acinetobacter baumannii, enabling rifabutin to effectively inhibit bacterial RNA polymerase in this Gram-negative pathogen at clinically suitable doses. The investigational therapy previously received Qualified Infectious Disease Product (QIDP) designation from the U.S. FDA, making it eligible for priority review, Fast Track designation, and a five-year extension of market exclusivity upon approval.
The RIV-TARGET Phase 3 study (NCT07326540) is a randomized, active-controlled, two-part parallel-group trial evaluating the efficacy and safety of BV100 combined with low-dose polymyxin B in patients with suspected or confirmed CRABC-associated HABP or VABP.
The pivotal Part A of the study aims to enrol approximately 300 patients and will compare BV100 plus low-dose polymyxin B with a control regimen of colistin plus high-dose ampicillin-sulbactam. Both treatment arms may include meropenem as background therapy in cases of polymicrobial infection. The primary endpoint of the trial is 28-day all-cause mortality in the CRABC microbiological modified intention-to-treat population. Secondary endpoints include clinical cure at test-of-cure, ventilator-free days, and duration of ICU and hospital stay.
The study also includes Part B, an open-label cohort expected to enrol around 25 patients with CRABC infections that are resistant to colistin or polymyxin B, or in cases where prior treatment with these agents has failed. This arm is intended to evaluate BV100’s efficacy and safety in patients with extremely limited treatment options.
The Phase 3 program builds on encouraging results from an earlier Phase 2 trial in ventilator-associated pneumonia patients with confirmed carbapenem-resistant A. baumannii infections. In that study, BV100 combined with polymyxin B demonstrated a 50% relative reduction in 28-day all-cause mortality compared with best available therapy, with mortality rates of 25% in the BV100 arm versus 60% in the control group. The regimen was generally safe and well tolerated.
BioVersys expects the global Phase 3 study to report results toward the end of 2027, with regulatory submissions planned in 2028 across major markets including the United States, Europe, and China. In parallel, the company plans to initiate the open-label Phase 2b RIV-CARE trial in the first half of 2026 to generate real-world evidence comparing BV100 with best available therapy in regions with high antimicrobial resistance.
Acinetobacter baumannii is an opportunistic pathogen that primarily affects critically ill or immunocompromised patients in hospital settings. It can cause severe pneumonia and bloodstream infections and is known for its ability to survive on hospital surfaces and rapidly develop resistance to multiple antibiotics. Carbapenem-resistant strains represent one of the most urgent antimicrobial resistance threats globally, with BioVersys estimating more than one million hospital infections annually and mortality rates reaching up to 50% due to limited treatment options
Reference
BioVersys Receives Green Light from US FDA for BV100 HABP/VABP Phase 3 Pivotal Trial Start, 16 March 2026, BioVersys Receives Green Light from US FDA for BV100 HABP/VABP Phase 3 Pivotal Trial Start | BioVersys
Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients with Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (RIV-TARGET), ClinicalTrials.gov ID NCT07326540, Study Details | NCT07326540 | Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex | ClinicalTrials.gov
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.