rifabutin intravenous infusion (BV100) / BioVersys - LARVOL DELTA

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

Pharmacokinetics and safety of BV100 in epithelial lining fluid and plasma (ESCMID Global 2025) - No abstract available

Clinical • PK/PD data

Determination of the pharmacodynamic targets of BV100 in the neutropaenic murine lung infection model (ESCMID Global 2025) - No abstract available

PK/PD data • Preclinical • Infectious Disease • Respiratory Diseases

Determination of the pharmacodynamic targets of BV100 in the neutropaenic murine thigh infection model (ESCMID Global 2025) - No abstract available

PK/PD data • Preclinical • Infectious Disease

Acinetobacter baumannii Complex Infections: New Treatment Options in the Antibiotic Pipeline. (PubMed, Microorganisms) - "Furthermore, many older agents, such as polymyxin and colistin, have limited lung penetration and are associated with significant toxicities. In order to place these newer molecules in context and to help clinicians appreciate the emerging potential drug development pipeline, we describe the in vitro activity, mechanisms of action, and clinical trial data not only for the commercially now available alternatives, such as cefiderocol and sulbactam-durlobactam, but also review these topics for molecules undergoing phase II and III clinical trials. Specifically, we discuss and analyze data related to four novel drugs from ABC: BV-100, cefepime-zidebactam, zosurabalpin, and OMN6."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases • Septic Shock

Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: BioVersys AG | Recruiting ➔ Completed

Trial completion • Infectious Disease

PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB (clinicaltrials.gov) - P2 | N=39 | Completed | Sponsor: BioVersys AG | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pneumonia • Respiratory Diseases

A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment (clinicaltrials.gov) - P1 | N=33 | Completed | Sponsor: BioVersys AG | Recruiting ➔ Completed

Trial completion • Hepatology

Potentially effective antimicrobial treatment for pneumonia caused by isolates of carbapenem-resistant and extensively drug-resistant Acinetobacter baumannii complex species: what can we expect in the future? (PubMed, Expert Rev Anti Infect Ther) - "Doubling the routine intravenous maintenance dosages of conventional tigecycline (100 mg every 12 h) and minocycline (200 mg every 12 h) might be recommended for the effective treatment of pneumonia caused by CR/XDR-Abc. Nebulized polymyxin E, novel parenteral rifabutin BV100, and new polymyxin derivatives (SPR206, MRX-8, and QPX9003) could be considered supplementary combination options with other antibiotic classes. Regarding other novel antibiotics, the potency of sulbactam-durlobactam (1 g/1 g infused over 3 h every 6 h intravenously) combined with imipenem-cilastatin, and the β-lactamase inhibitor xeruborbactam, is promising. Continuous infusion of full-dose cefiderocol is likely an effective treatment regimen for CR/XDR-Abc pneumonia. Zosurabalpin exhibits potent anti-CR/XDR-Abc activity in vitro, but its practical use in clinical therapy remains to be evaluated. The clinical application of antimicrobial peptides and bacteriophages requires validation."

Journal • Review • Infectious Disease • Pneumonia • Respiratory Diseases

PK of BV100 in Patients VABP Suspected or Confirmed to Be Due to CRAB (clinicaltrials.gov) - P2 | N=35 | Active, not recruiting | Sponsor: BioVersys AG | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jun 2024 ➔ Nov 2024

Enrollment closed • Trial primary completion date • Infectious Disease • Pneumonia • Respiratory Diseases

Effect of BV100 on the Pharmacokinetics of Midazolam and its metabolite 1-hydroxymidazolam in healthy volunteers. (IDWeek 2024) - No abstract available

Clinical • PK/PD data • Infectious Disease

Performance, Meat Quality and Meat Metabolomics Outcomes: Efficacy of 3-Nitrooxypropanol in Feedlot Beef Cattle Diets. (PubMed, Animals (Basel)) - "30 Nellore animals with an average weight of 407.25 ± 2.04 kg, were distributed in a completely randomized design across the following treatments: 1-Control (without inclusion of 3-NOP); 2-BV75 (inclusion of 3-NOP at 75 mg/kg DM); 3-BV100 (inclusion of 3-NOP at 100 mg/kg DM)...Partial separation of metabolomics observed between groups indicated changes in meat metabolism when comparing the control group with the 3-NOP group, identifying metabolites with a variable importance projection (VIP) score > 1. In conclusion, supplementation with 3-NOP effectively reduced methane emissions and did not negatively influence animal performance."

Journal

Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: BioVersys AG | Trial primary completion date: Jun 2024 ➔ Oct 2024

Trial primary completion date • Infectious Disease

Dietary Bacillus velezensis KNF-209 supplementation improves growth performance, enhances immunity, and promotes gut health in broilers. (PubMed, Poult Sci) - "The cecal acetic acid and propionic acid levels in the BV groups and lactic acid levels in the BV 50, BV 100, and BV 200 groups (P < 0.05) were significantly higher compared to those in the CON group. Overall, dietary BV-KNF-209 supplementation significantly improved broiler growth performance, an effect that may have been achieved by heightening immunity, increasing digestive enzyme activity, and raising intestinal short-chain fatty acids and lactic acid levels."

Journal • Oncology • IL10 • IL1B • IL6 • TNFA

A Study to Assess the Phamacokinetics of BV100 in Participants With Varying Degrees of Hepatic Impairment (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: BioVersys AG | Trial completion date: Sep 2023 ➔ Sep 2024 | Trial primary completion date: May 2023 ➔ Jun 2024

Trial completion date • Trial primary completion date • Hepatology

In vivo efficacy of BV100 in combination with polymyxin B (POL) in neutropenic murine thigh infection models of Acinetobacter baumannii (ECCMID 2024) - No abstract available

Combination therapy • Preclinical • Infectious Disease

Pharmacokinetics and safety of BV100 in subjects with mild and moderate hepatic impairment (ECCMID 2024) - No abstract available

Clinical • PK/PD data • Hepatology

BV100 displays potent efficacy against Acinetobacter baumannii in neutropenic murine thigh and lung infection models (ECCMID 2024) - No abstract available

Preclinical • Infectious Disease • Respiratory Diseases

Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100 (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: BioVersys AG

Trial completion date • Infectious Disease

To Evaluate the Effect of Multiple Doses of Itraconazole on the Pharmacokinetics of BV100 (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: BioVersys AG | Not yet recruiting ➔ Completed

Trial completion • Infectious Disease