BioVersys Publishes BV100 Lung Penetration and Drug Interaction Data

BioVersys AG, a clinical-stage biopharmaceutical company based in Basel, Switzerland, has announced the publication of two Phase 1 clinical pharmacology studies of its lead asset, BV100, in two leading peer-reviewed journals: the International Journal of Antimicrobial Agents and the Journal of Antimicrobial Chemotherapy. BV100 is a novel intravenous formulation of rifabutin being developed for serious infections caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC), including hospital- and ventilator-associated bacterial pneumonia. The publications provide key data on lung penetration and drug-drug interactions, strengthening the scientific rationale for BV100 in critically ill patients.

The first study, published in the International Journal of Antimicrobial Agents, examined pulmonary penetration in 36 healthy male participants who received BV100 300 mg every 12 hours for four days. Results showed that rifabutin concentrations in lung fluid and alveolar macrophages exceeded plasma concentrations at every time point, with median penetration ratios of approximately 35-fold and over 300-fold, respectively. Repeated dosing was well tolerated. The authors concluded that these pulmonary exposures provide a strong pharmacological rationale for further clinical evaluation of BV100 in severe CRAB pneumonia. The second study, published in the Journal of Antimicrobial Chemotherapy, characterized drug-drug interactions across two Phase 1 trials. BV100 was found to be a mild CYP3A inducer, reducing midazolam exposure by approximately 47%, and a mild substrate for CYP3A inhibitors, with rifabutin exposure increasing 1.3- to 1.7-fold with itraconazole. This profile is milder than that of rifampicin, a strong CYP3A inducer, and BV100 was safe and well tolerated in both studies. According to Dr. Glenn Dale, Chief Development Officer of BioVersys and co-author, these papers address the questions that matter most for an intravenous antibiotic in critically ill pneumonia patients.

These Phase 1 datasets form part of the clinical pharmacology foundation for RIV-TARGET, the ongoing Phase 3 registration trial of BV100 in hospital- and ventilator-associated bacterial pneumonia caused by CRABC. Enrollment is ongoing, with topline data anticipated in early 2028. BV100 is also being studied in the open-label Phase 2b differentiation trial, RIV-CARE, in collaboration with ADVANCE-ID. In September 2026, BV100 received Fast Track Designation from the US FDA, building on its Qualified Infectious Disease Product (QIDP) designation granted in 2019. Dr. Marc Gitzinger, CEO and founder of BioVersys, noted that carbapenem-resistant Acinetobacter baumannii represents one of the highest medical needs in infectious disease, and these data continue to strengthen the growing scientific basis for BV100 therapy in CRABC pneumonia.