rifabutin intravenous infusion (BV100) / BioVersys - LARVOL DELTA

Pulmonary Penetration of Intravenous Rifabutin in Healthy Participants: A Multiple-Dose Pharmacokinetic Study. (PubMed, Int J Antimicrob Agents) - "Intravenous rifabutin achieves pulmonary exposures substantially exceeding plasma concentrations, providing a strong pharmacological rationale for further clinical evaluation of BV100 in severe CRAB pneumonia."

Journal • PK/PD data • Infectious Disease • Pneumonia • Respiratory Diseases

BV100 (rifabutin IV) drug interaction studies in healthy subjects with index CYP450 3A probes midazolam and itraconazole. (PubMed, J Antimicrob Chemother) - "BV100 is a mild/weak CYP3A enzyme inducer and a mild substrate for CYP3A inhibitors. However, co-administration with strong CYP3A inhibitors resulted in a disproportionate increase in exposure to the active metabolite 25-O-desacetyl rifabutin, leading to an ∼2-fold increase in total active-moiety exposure. Clinical monitoring is advised when BV100 is co-administered with a strong CYP3A inhibitor. BV100 was safe and well tolerated."

Journal • Infectious Disease

Intravenous BV100 (Rifabutin for Infusion) plus Polymyxin B versus Best Available Therapy for Ventilator-Associated Bacterial Pneumonia Suspected or Confirmed due to Carbapenem-Resistant Acinetobacter baumannii: Exploratory Efficacy and Safety Results from a Randomized Phase 2 Trial (IDWeek 2026) - No abstract available

Clinical • P2 data • Infectious Disease

Intravenous BV100 (Rifabutin for Infusion) plus Polymyxin B versus Best Available Therapy for Ventilator-Associated Bacterial Pneumonia Suspected or Confirmed due to Carbapenem-Resistant Acinetobacter baumannii: Exploratory Efficacy and Safety Results from a Randomized Phase 2 Trial (IDWeek 2026) - No abstract available

Clinical • P2 data • Infectious Disease

BioVersys granted Fast-Track Designation from US FDA for BV100 (BioVersys Press Release) - "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."

Fast track • Infectious Disease

BV100-010: A study of BV100 plus low dose polymyxin B for treating hospital -acquired and ventilator-associated pneumonia caused by antibiotic resistant Acinetobacter bacteria (clinicaltrialsregister.eu) - P2/3 | N=29 | Not yet recruiting | Sponsor: Bioversys S.A.S.

New P2/3 trial • Infectious Disease • Pneumonia • Respiratory Diseases

A Single Centre, Open-label, 2-period Fixed-sequence, Phase I Clinical Study to Evaluate the Effect of BV100 on the Pharmacokinetics of Polymyxin B in Healthy Volunteers (clinicaltrials.gov) - P1 | N=16 | Recruiting | Sponsor: BioVersys SAS

New P1 trial

Newly Emerging Nanotechnologies of Innovative Devices for Radioisotope Batteries. (PubMed, Nanomaterials (Basel)) - "These advances have enabled notable civilian applications, such as the BV100 and "Zhulong No.1" nuclear batteries. Despite this progress, challenges remain in ensuring long-term material stability under extreme environments, maintaining performance consistency during macroscopic device integration, and addressing the high fabrication costs. The review concludes by outlining future research directions, including the development of novel nanomaterial systems, innovative nanostructure designs, scalable manufacturing processes, and enhanced device stability and safety, to further advance next-generation radioisotope batteries."

Journal • Review

RIV-TARGET: Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (clinicaltrials.gov) - P3 | N=248 | Recruiting | Sponsor: BioVersys SAS | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumonia • Respiratory Diseases

Assessment of the pharmacodynamics of intravenous rifabutin (BV100) in combination with cefiderocol against Acinetobacter baumannii in a hollow fibre infection model (ESCMID Global 2026) - No abstract available

Combination therapy • PK/PD data • Infectious Disease

Antibacterial effect of BV100 plus polymyxin B compared to meropenem against Acinetobacter baumannii assessed over seven-day exposures in an in vitro pharmacokinetic model (ESCMID Global 2026) - No abstract available

PK/PD data • Preclinical

Accurate and reproducible determination of rifabutin MIC demonstrates that BV100 remains effective against Acinetobacter baumannii isolates harboring RpoB mutation (ESCMID Global 2026) - No abstract available

BioVersys AG…announced Monday that the U.S. Food and Drug Administration has approved the enrollment of U.S. patients in its global Phase 3 trial for BV100 (Investing.com) - "The trial, designated RIV-TARGET (NCT07326540), will evaluate BV100 in patients with hospital-acquired or ventilator-associated bacterial pneumonia caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus Complex...The company has begun a Phase 2b clinical trial for its tuberculosis treatment, alpibectir-ethionamide (AlpE), in combination with standard tuberculosis drugs. This trial is being conducted across six African countries and is part of the European Union’s IMI2 UNITE4TB project. Results from this study are anticipated by the end of 2027."

P2b data • Trial status • Pneumonia • Tuberculosis

Single-ascending and multiple-ascending dose study of the pharmacokinetics, safety, and tolerability of BV100 (rifabutin for infusion) in healthy volunteers. (PubMed, Antimicrob Agents Chemother) - P1 | "BV100 demonstrated a dose-proportional PK profile and was generally safe and well tolerated. Based on these results, BV100 doses of 200-300 mg q12h are undergoing evaluation in a Phase 2 study for treating carbapenem-resistant A. baumannii infections.CLINICAL TRIALSThis study is registered with ClinicalTrials.gov as NCT04636983 and NCT05087069."

Journal • PK/PD data • Infectious Disease

BV100-011: A Phase 1 study to evaluate the effect of BV100 on the pharmacokinetics of polymyxin B in healthy volunteers (clinicaltrialsregister.eu) - P1 | N=16 | Not yet recruiting | Sponsor: Bioversys S.A.S.

New P1 trial • Infectious Disease

RIV- CARE: Safety, Pharmacokinetics and Efficacy of BV100 Plus Low Dose Polymyxin B Plus Ceftazidime/Avibactam, or Plus Cefiderocol in Patients With Pulmonary and Extrapulmonary Infections Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: BioVersys AG

New P2 trial • CNS Disorders • Infectious Disease • Pneumonia • Respiratory Diseases

RIV-TARGET: Efficacy and Safety of BV100 Plus Low Dose Polymyxin B Versus Colistin Plus High-dose Ampicillin/Sulbactam in Patients With Hospital-acquired or Ventilator-associated Bacterial Pneumonia Due to Carbapenem-resistant Acinetobacter Baumannii-calcoaceticus Complex (clinicaltrials.gov) - P3 | N=248 | Not yet recruiting | Sponsor: BioVersys SAS

New P3 trial • Infectious Disease • Pneumonia • Respiratory Diseases

Drug-Drug Interaction Studies in Healthy Volunteers with BV100 plus Midazolam or Itraconazole as Index CYP3A Substrate and Inhibitor (IDWeek 2025) - No abstract available

Clinical • Infectious Disease

Antibiotics and non-traditional antimicrobial agents for carbapenem-resistant Acinetobacter baumannii in Phase 1, 2, and 3 clinical trials. (PubMed, Expert Opin Investig Drugs) - "Specifically, 9 antibiotics are in Phase 1 (R-327, xeruborbactam/QPX-7728, upleganan/SPR-206, MRX-8, QPX-9003, zifanocycline/KBP-7072, apramycin/EBL-1003, zosurabalpin/RG-6006, and ANT-3310), two in Phase 2 (BV-100, OMN-6), and two in Phase 3 (zidebactam/WCK-5222, funobactam/XNW-4107) clinical trials...In particular, two monoclonal antibodies (TRL-1068, CMTX-101), a phage therapy (Phagebank), an immune-modulating agent (recombinant human plasma gelsolin/Rhu-pGSN), a microbiome-modulating agent (SER-155), and an engineered cationic antibiotic peptide (PLG-0206). Several agents with promising characteristics against CRAB infections are in clinical development (Phases 1, 2, and 3). The urgent need for therapeutic options against CRAB infections necessitates optimizing efforts and time for introducing successfully studied agents into clinical practice."

Journal • Review • Infectious Disease • GSN

Carbapenem Resistance in Acinetobacter baumannii: Mechanisms, Therapeutics, and Innovations. (PubMed, Microorganisms) - "Emerging treatment strategies are discussed, such as the use of new beta-lactam-beta-lactamase inhibitor combinations (e.g., sulbactam-durlobactam), siderophore cephalosporins, next-generation polymyxins, as well as novel agents like zosurabalpin and rifabutin (BV100). Together, these innovations represent a multifaceted strategy to overcome CRAB infections, yet their successful implementation requires further clinical validation and coordinated surveillance efforts. This analysis highlights the urgent need for continued investment in innovative treatments and effective resistance monitoring to limit the spread of CRAB and protect the effectiveness of last-line antibiotics."

Journal • Review • Critical care • Infectious Disease

The potential effect of gut microbiota on the secretion of selected cytokines by human cells in vitro. (PubMed, Sci Rep) - "Moreover, PD 100 µg and 400 µg lysates significantly increased secretion of IL-8 by HT-29 cells compared to BV 100 µg and 400 µg lysates (p < 0.05). CP, BV, PD and RA 100 µg lysates significantly lowered IL-13 secretion by PBMC vs. control (p < 0.001). For a better understanding of the mechanisms of action of gut microflora and their impact on parameters important in asthma, complex studies which compare the asthma and control samples should be carried out in the future."

Journal • Preclinical • Asthma • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases • CXCL8 • IL13 • IL4 • IL5

BioVersys to Present BV100 Phase 2 Data at 35th ESCMID Global 2025 (GlobeNewswire) - "BioVersys AG...announced today its participation in the 35th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2025, April 11-15, 2025) where it will present the latest clinical and preclinical data on BV100...The conference will feature an oral presentation of the BV100 Phase 2 data in patients with ventilator associated bacterial pneumonia (VABP) suspected or confirmed to be due to carbapenem resistant Acinetobacter baumannii (CRAB)."

Clinical data • Preclinical • Pneumonia

BioVersys Announces Important BV100 Patent Granted by Chinese Patent Office (GlobeNewswire) - "BioVersys AG...announced today, that the company was granted important patent claims in China for its BV100 technology...BV100 is a novel formulation of rifabutin which is suitable for intravenous administration. BV100 is based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex and is being developed for resistant hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB)....'We are preparing to start a Phase 1 clinical trial in China soon, which will enable us to include China in our BV100 Phase 3 registration trial which is planned to start in H2 2025.'"

New P1 trial • New P3 trial • Patent • Infectious Disease

Efficacy and safety in a Phase 2 study of intravenous BV100 combined with polymyxin B versus best available therapy in adult subjects with ventilator-associated bacterial pneumonia suspected or confirmed to be due to carbapenem resistant Acinetobacter baumannii (ESCMID Global 2025) - No abstract available

Clinical • Late-breaking abstract • P2 data • Infectious Disease • Pneumonia • Respiratory Diseases

Antibacterial effect of BV100 plus polymyxin B, at simulated human drug exposures, against Acinetobacter baumannii in an in vitro infection model (ESCMID Global 2025) - No abstract available

Preclinical • Infectious Disease