Ad hoc announcement pursuant to Art. 53 LR
Basel, Switzerland. April 22, 2026, 7.00am CEST
- Completing the Phase 1 clinical trial in China paves the way for Chinese sites to join the global BV100 Phase 3 RIV-TARGET trial by the end of 2026.
- The Phase 3 RIV-TARGET trial is expected to enrol ~300 patients across ~100 sites in ~15 countries, and has recently achieved the first patient, first visit milestone.
- BV100 is a potential best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii (CRAB).
- Noteworthy targets: initiation of Chinese sites in Phase 3 (by end‑2026); Phase 2b RIV‑CARE interim analysis (by end‑2026); Phase 3 RIV-TARGET top‑line data (expected within ~2 years).
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 completion of the clinical assessment of BV100 in healthy subjects in the Phase 1 clinical study conducted in China.
The completion of this mandatory Phase 1 safety and pharmacokinetic clinical trial in China is crucial in the development of BV100. With this accomplishment, BioVersys can initiate the process to onboard Chinese sites in the global Phase 3 RIV-TARGET trial of BV100. BV100 was generally safe and well tolerated in this Phase 1 study in Chinese healthy volunteers.
Dr. Glenn E Dale, Chief Development Officer: “We are pleased with the development of our lead clinical asset BV100, and our progress toward including Chinese sites in the global Phase 3 RIV‑TARGET trial. Our ultimate aim is to provide BV100 access to patients in need across high-burden regions worldwide.”
CRAB infections are a serious health threat throughout the world, and the incidence rates are particularly high in China and Asia. Combined with very high resistance rates of 60-80% to carbapenems, Acinetobacter baumannii is a 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 bloodstream infections in China alone.
The global Phase 3 RIV-TARGET registration trial will assess BV100 in critically ill patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The RIV-TARGET trial, which recently announced the first patient, first visit milestone, is expected to enrol approximately 300 patients across ~100 sites in ~15 countries, with top-line results expected within the next two years.
In parallel to the Phase 3 RIV-TARGET trial, BioVersys has initiated an open-label Phase 2b differentiation trial (RIV-CARE) in South-East Asia in H1 2026, comparing BV100 with the best-available-therapy in multiple geographies. The Phase 2b trial will support differentiation and adoption of BV100, as the trial will provide real-world evidence of clinical practices in settings with very high drug resistance levels, with interim analysis planned for end of 2026. In November 2025, BioVersys announced that the ADVANCE-ID clinical trial network will support and collaborate with BioVersys in conducting the Phase 2b study. This support has been made possible thanks to the generous contribution of Wellcome who strengthened the ADVANCE-ID network with SGD 22 million (c. USD 17m or CHF 14m).
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