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BioVersys AG
/ Key word(s): Scientific publication
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.
About BV100 BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted US FDA Fast Track Designation in 2026 and QIDP Designation in May 2019, making BV100 eligible for priority FDA review and a five-year extension of market exclusivity upon approval of the first QIDP indication. About Acinetobacter baumannii Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multi-drug resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. BioVersys contact
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2418376 20.10.2026 CET/CEST