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 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." 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, the 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 (CRAB) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, 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.
About BioVersys BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant ("MDR") bacteria. Derived from the company's two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company's most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland. BioVersys contact
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.
[1] Single- and Multiple-ascending Dose Study of the Pharmacokinetics, Safety and Tolerability of BV100 (rifabutin for infusion) in Healthy Volunteers; Christian Kemmer et al, 2026. https://journals.asm.org/doi/10.1128/aac.01582-25 End of Media Release |
2285118 04.03.2026 CET/CEST
