BioVersys announces publication of BV100 lung penetration and drug interaction data in two leading peer-reviewed antimicrobial journals

 Basel, Switzerland. October 20, 2026, 7am CET

• International Journal of Antimicrobial Agents publishes data showing that BV100 reaches concentrations in lung fluid and alveolar macrophages approximately 35-fold and over 300-fold higher, respectively, than in plasma, providing a strong pharmacological rationale for BV100 use in severe CRAB pneumonia
• Journal of Antimicrobial Chemotherapy publishes data showing BV100 is a mild CYP3A inducer and a mild substrate for CYP3A inhibitors, a milder drug interaction profile than rifampicin, supporting its use alongside the many medicines given to critically ill patients
• Both Phase 1 datasets form part of the clinical solid pharmacology foundation of RIV-TARGET, the ongoing Phase 3 registration trial of BV100 in hospital- and ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC); trial enrollment is ongoing, with topline data read-out anticipated for early 2028

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (MDR) bacteria, announced today the publication of two Phase 1 clinical pharmacology studies of BV100, its lead clinical asset, in two leading peer-reviewed journals in the field of antimicrobial therapy: the International Journal of Antimicrobial Agents, the official journal of the International Society of Antimicrobial Chemotherapy, and the Journal of Antimicrobial Chemotherapy, the official journal of the British Society for Antimicrobial Chemotherapy.

Dr. Glenn Dale, Chief Development Officer of BioVersys and co-author of the publications, commented: “These two papers address the questions that matter most for an intravenous antibiotic in critically ill pneumonia patients. BV100 has very good distribution in lung fluid and alveolar macrophages, and its drug-interaction profile is mild and manageable. We are pleased to share these data with the infectious disease and critical care community as we continue to enroll patients in our Phase 3 study RIV-TARGET.”

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys, added: “Carbapenem-resistant Acinetobacter baumannii represents one of the highest medical needs in infectious disease, and patients fighting these life-threatening infections have very few options. These data continue to strengthen the growing scientific basis for BV100 therapy in CRABC pneumonia and bring us a step closer to delivering a much-needed new treatment option to patients and the physicians who care for them.”

International Journal of Antimicrobial Agents: lung penetration study

The paper, entitled “Pulmonary Penetration of Intravenous Rifabutin in Healthy Participants: A Multiple-Dose Pharmacokinetic Study,” was published in the International Journal of Antimicrobial Agents (DOI: 10.1016/j.ijantimicag.2026.108014). In 36 healthy male participants receiving BV100 (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, and 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.

Journal of Antimicrobial Chemotherapy: drug-drug interaction studies

The paper, entitled “BV100 (rifabutin IV) drug interaction studies in healthy subjects with index CYP450 3A probes midazolam and itraconazole,” was published in the Journal of Antimicrobial Chemotherapy (DOI: 10.1093/jac/dkag317). Across two Phase 1 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 with itraconazole. This is a milder interaction profile than that of rifampicin, a strong CYP3A inducer, and BV100 was safe and well tolerated in both studies.

BV100 is currently studied in two clinical trials: the pivotal Phase 3 global registrational trial, RIV-TARGET and the open-label Phase 2b differentiation trial, RIV-CARE in collaboration with ADVANCE-ID. In September 2026, BV100 was granted Fast Track Designation by the US FDA, under the Qualified Infectious Disease Product (QIDP) Designation received in 2019.

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