BioVersys Announces First Subjects Dosed in Phase 1 Clinical Trial of Bv100 in China

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. November 06, 2025, 7am CEST

• First healthy volunteer dosed with BV100 in China in mandatory Phase 1 trial
• Inclusion of Chinese clinical sites by H2 2026, into single global Phase 3 registration trial as planned

BioVersys AG, 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 dosing of the first subject in a Phase 1 clinical trial with BV100 in China.

The mandatory Phase 1 clinical trial in healthy volunteers in China precedes the inclusion of Chinese clinical sites by late 2026 into the single Global Phase 3 registration trial of BV100 in Ventilator Associated Bacterial Pneumonia (VABP). Recruitment in other geographies will start earlier.

BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for multi-drug resistant (“MDR”) hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB).

While CRAB infections are a serious health threat throughout the world, incidence rates for Acinetobacter infections are particularly high in China and Asia. Combined with very high resistance rates of 60-80% to carbapenems, Acinetobacter baumannii is the leading cause of death attributable to antimicrobial resistance in China[1]. Based on recent epidemiology data, BioVersys estimates that over 1 million patients annually are at risk of severe CRAB pneumonia and blood stream infections in China alone.

In April 2025, BioVersys presented outstanding Phase 2 clinical data for BV100 in Ventilator Associated Bacterial Pneumonia (VABP) at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in Vienna, Austria. In that Phase 2, BV100 demonstrated strong signs of efficacy by halving the mortality rate in critically ill patients suffering from CRAB infections compared with best available therapy. Besides the strong efficacy signal, BV100 was also generally safe and well tolerated. In Part B of the Phase 2 trial, BV100 also proved effective in patients failing best available therapy and those suffering from totally drug-resistant infections.

Dr. Glenn E Dale, Chief Development Officer: “There is a high burden of CRAB in China and South-East Asia. As such, we are working with regulatory agencies from US, Europe and China to include patients from the three regions into a single global Phase 3 registration trial. The timely initiation of the Phase 1 safety and pharmacokinetic study in China demonstrates that the process to eventually include Chinese clinical sites into our global Phase 3 clinical program is progressing well. BioVersys is committed to bringing BV100 to patients in need in as many regions of the world as possible”

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