BioVersys AG has announced the publication of two Phase 1 clinical pharmacology studies of its lead antibiotic candidate BV100 in the International Journal of Antimicrobial Agents and the Journal of Antimicrobial Chemotherapy. The data, disclosed via NEWMEDIAWIRE, show that intravenous rifabutin achieves high concentrations in lung fluid and immune cells and has a drug interaction profile that is milder than that of rifampicin, a widely used antibiotic. The publications matter because they provide the pharmacological foundation for BV100’s ongoing Phase 3 registration trial in hospital- and ventilator-associated pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC), a pathogen with limited treatment options and high mortality.
The first paper, published in the International Journal of Antimicrobial Agents (10.1016/j.ijantimicag.2026.108014), reports a study in 36 healthy male participants who received BV100 300 mg every 12 hours for four days. Concentrations of rifabutin 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 conclude that these pulmonary exposures provide a strong pharmacological rationale for further clinical evaluation of BV100 in severe CRAB pneumonia.
The second paper, published in the Journal of Antimicrobial Chemotherapy (DOI: 10.1093/jac/dkag317), describes two Phase 1 drug-drug interaction studies. BV100 was shown to be a mild CYP3A inducer, reducing exposure to the probe drug midazolam by approximately 47%, and a mild substrate for CYP3A inhibitors, with rifabutin exposure increasing 1.3- to 1.7-fold when co-administered with itraconazole. This is a milder interaction profile than that of rifampicin, a strong CYP3A inducer. BV100 was safe and well tolerated in both studies. The milder profile is clinically important because critically ill patients often receive multiple medications, and fewer or less severe drug interactions can simplify dosing and reduce the risk of subtherapeutic or toxic levels.
Dr. Glenn Dale, Chief Development Officer of BioVersys and co-author of the publications, said the papers address the questions that matter most for an intravenous antibiotic in critically ill pneumonia patients, noting that BV100 has very good distribution in lung fluid and alveolar macrophages and a mild, manageable drug-interaction profile. Dr. Marc Gitzinger, Chief Executive Officer and founder, added that carbapenem-resistant Acinetobacter baumannii represents one of the highest medical needs in infectious disease and that these data strengthen the scientific basis for BV100 therapy in CRABC pneumonia.
BV100 is currently being studied in the pivotal Phase 3 global registrational trial, RIV-TARGET, and in the open-label Phase 2b differentiation trial, RIV-CARE, in collaboration with ADVANCE-ID. Enrollment in RIV-TARGET is ongoing, with topline data anticipated in early 2028. BV100 received Fast Track Designation from the US FDA in September 2026, under the Qualified Infectious Disease Product Designation granted in 2019. The company forecasts that annual carbapenem-resistant A. baumannii infections in hospitals have surpassed one million globally, with mortality rates up to 50% due to limited treatment options. The new publications thus provide critical support for a candidate that could address a significant unmet need in severe hospital-acquired infections.
