BioVersys AG, a clinical-stage biopharmaceutical company developing novel antibacterials for multi-drug resistant infections, announced the publication of two Phase 1 clinical pharmacology studies of its lead asset BV100 in the International Journal of Antimicrobial Agents and the Journal of Antimicrobial Chemotherapy. The data provide pharmacological support for BV100 in severe 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 (DOI: 10.1016/j.ijantimicag.2026.108014), reports a lung penetration study in 36 healthy male participants who received intravenous rifabutin 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, 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 midazolam exposure 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 profile is milder than that of rifampicin, a strong CYP3A inducer, and BV100 was safe and well tolerated in both studies.
Dr. Glenn Dale, Chief Development Officer of BioVersys and co-author of the publications, said the papers address 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 these data strengthen the scientific basis for BV100 therapy in CRABC pneumonia.
The publications come as BV100 is being studied in the pivotal Phase 3 global registrational trial, RIV-TARGET, and 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.
For clinicians and patients, the data suggest BV100 could offer a lung-penetrant option with fewer drug-interaction concerns than rifampicin, a relevant factor given the multiple medications critically ill patients receive. BioVersys forecasts more than one million carbapenem-resistant A. baumannii infections globally each year, with mortality rates up to 50%. The company is located in Basel, Switzerland, and its website is www.bioversys.com.
