BioVersys Announces Publication of BV100 Phase 1 Clinical Data in Journal of Antimicrobial Agents and Chemotherapy

Basel, Switzerland. March 04, 2026, 7am CET

• BV100 Phase 1, single- and multiple-ascending dose clinical trial data include pharmacokinetics, safety and tolerability data.
• BV100 demonstrated a dose-proportional pharmacokinetic profile and was generally safe and well tolerated.
• BV100 global Phase 3 clinical trial is initiated with read-out expected in H2 2027.
• Additional Phase 2b to demonstrate clinical differentiation and further de-risk BV100’s registrational path to be initiated in 2026 with interim data read-out expected end of 2026.

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 Phase 1, single- and multiple-ascending dose (SAD and MAD) clinical trial data including pharmacokinetics, safety and tolerability of BV100 in healthy volunteers in the Journal of Antimicrobial Agents and Chemotherapy.[1]

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 MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant strains.

BV100 demonstrated a dose-proportional PK profile and was generally safe and well tolerated. Based on these positive results, BV100 doses of 200-300 mg administered every 12 hours have been evaluated in a Phase 2 clinical trial in Ventilator Associated Bacterial Pneumonia (VABP) patients, for treating carbapenem-resistant A. baumannii (CRAB) infections. BV100 demonstrated a clear survival benefit, resulting in a 50% relative reduction in all-cause mortality (ACM) in VABP patients suffering from CRAB infections compared with best available therapy (BAT), and was generally safe and well tolerated.

In December 2025, BV100 advanced into a global registration Phase 3 clinical trial (RIV-TARGET), in HABP/VABP patients suffering from CRAB infections, employing a similar  study design to the successful Phase 2 trial. The first patient is expected to be dosed in the coming weeks, and Phase 3 read-out is expected in H2 2027.

A global open-label Phase 2b clinical differentiation trial (RIV-CARE) will be initiated in H1 2026 and will compare BV100 with best available therapy in multiple geographies. Primary efficacy, safety and secondary endpoints will be similar to the Phase 3 trial described above. An interim analysis of the Phase 2b trial is expected towards end 2026.

Dr. Glenn E Dale, Chief Development Officer: “Multi-drug resistant infections, especially those acquired in a hospital setting are a rising medical problem across healthcare systems worldwide. Following the regulatory interactions we have had with the FDA and the CHMP, we continue to make progress with our antibiotic candidate, BV100. We are now advancing BV100 into global registrational study program with our two trials RIV-TARGET and RIV-CARE. As the RIV-CARE trial will be open-label, we are looking forward to first interim data towards end 2026.”

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