BioVersys AG: BioVersys to present BV100 Phase 2 data at 35th ESCMID Global 2025

BioVersys AG / Key word(s): Conference
BIOVERSYS TO PRESENT BV100 PHASE 2 DATA AT 35TH ESCMID GLOBAL 2025

08.04.2025 / 07:00 CET/CEST

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Basel, Switzerland. April 08, 2025, 7am CEST.

• Oral presentation on April 13, 2025, highlighting positive BV100 Phase 2 VABP trial read-out with excellent efficacy and safety data
• Complementary poster presentations featuring clinical & preclinical data from BV100 on Acinetobacter baumannii and preclinical BV500 on non-tuberculosis mycobacterium (NTM)
• BioVersys symposium - Conquering the superbug crisis: new hope for treating carbapenem-resistant Acinetobacter baumannii (CRAB)

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 multidrug-resistant (MDR) bacteria, announced today its participation in the 35^th 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 and BV500. 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).

Dr. Glenn Dale, Chief Development Officer of BioVersys: "We are delighted to be offered the opportunity to present eight sets of preclinical and clinical data on BV100 and BV500 at this prestigious conference. Over the last few years, we have generated a tremendous amount of robust preclinical data which formed the basis on which we initiated the Phase 2 trial with BV100. This trial recently reported strong survival benefit. We are convinced that BV100 has the potential to become a game changer in the way patients with CRAB infections are treated."

BV100 for Carbapenem Resistant Acinetobacter baumannii:

Oral Presentation: 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 baumanni

Late-Breakers Oral Sessions: LB004 - Trials in severe infections

Presenter: Glenn E. Dale, PhD, Chief Development Officer

Timing: Sunday April 13, 2025; 16:15 - 18:15 pm CEST, Hall 9

BV100 plus polymyxin B was generally safe and well-tolerated in this patient population. The BV100 arms demonstrated a substantial survival benefit compared to BAT and thus warrants further development.

BioVersys Symposium: Conquering the superbug crisis: new hope for treating carbapenem-resistant Acinetobacter baumanni

Integrated Symposium IS50

Chairs: Ana Gales, Brazil ESCMID-appointed chair, Sumathi Nambiar, United States, Chair

Timing: Monday April 14, 2025; 16:15 - 17:45 pm CEST, Hall 8

Acinetobacter baumannii is a major concern in healthcare due to its ability to survive on surfaces and its resistance to many antibiotics. The challenges posed by A. baumannii are exacerbated by limited resources, antibiotic resistance, inadequate surveillance, and access to healthcare.
This session aims to present the latest advancements in the development of antibiotics targeting carbapenem-resistant A. baumannii (CRAB) focusing on Hospital-Acquired Ventilator-Associated Pneumonia (HAVP) and Bloodstream Infections (BSI). As an example, the global impact of rifabutin for injection in combination with low-dose polymyxin B will be explored emphasizing its potential to address the urgent need for new treatments in regions heavily burdened by antibiotic resistance.
Attendees will gain insights into the challenges and successes encountered during the development process of such antibiotics. This session is designed for researchers, clinicians, and healthcare professionals interested in cutting-edge antimicrobial therapies and their role in combating antibiotic resistance.

ePoster #2568: Rifabutin exerts potent intracellular and biofilm eradication activity against Acinetobacter baumannii

Poster Session 5c: New or repurposed antibacterial agents: Clinical studies and randomised trials

Presenter: Marija Miljkovic, PhD, Research Scientist

Timing: Sunday April 13, 2025; 12:00 - 13:30 pm CEST

Rifabutin (RBT) exerts potent intracellular and biofilm eradication activity against A. baumannii, that is similar or superior to the activity of the SoC drugs.

ePoster #2491: Determination of the pharmacodynamic targets of BV100 in the neutropaenic murine thigh infection model

Poster Session 5b: Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring (incl lab methods, models, in vitro and in vivo studies)

Presenter: Michel Pieren, PhD, Clinical Program Team Leader

Timing: Sunday April 13, 2025; 12:00 - 13:30 pm CEST

BV100 showed potent in vivo efficacy in neutropenic murine thigh infection models against 8 A. baumannii strains (including CRAB and rifampicin-resistant strains) with a broad rifabutin MIC range. The PDT for BV100 in neutropenic murine thigh infection models were successfully determined and provide a basis for estimating the human exposure required for efficacy against A. baumannii needed for the further development of BV100.

ePoster #2490: Determination of the pharmacodynamic targets of BV100 in the neutropaenic murine lung infection model

Poster Session 5b: Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring (incl lab methods, models, in vitro and in vivo studies)

Presenter: Michel Pieren, PhD, Clinical Program Team Leader

Timing: Sunday April 13, 2025; 12:00 - 13:30 pm CEST

BV100 showed potent in vivo efficacy in neutropenic murine lung infection models towards 11 A. baumannii strains (including CRAB and rifampicin-resistant strains) with a broad rifabutin MIC range. In addition, significant ELF exposures of BV100 were detected in mice emphasizing its potential use in treating serious infections. This robust PK/PD dataset is crucial for estimating the human exposure required for efficacy and proper Phase 3 dose justification.

ePoster #2457: Antibacterial effect of BV100 plus polymyxin B, at simulated human drug exposures, against Acinetobacter baumannii in an in vitro infection model

Poster Session 5b: Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring (incl lab methods, models, in vitro and in vivo studies)

Presenter: Marie Attwood, PhD, Project Manager & Head Research Scientist

Timing: Sunday April 13, 2025; 12:00 - 13:30 pm CEST

In comparison to polymyxin B alone, the combination of RBT (BV100) and polymyxin B results in more rapid early pathogen clearance, and suppression of total pathogen bacterial counts and resistant sub populations.

ePoster #2517: Pharmacokinetics and safety of BV100 in epithelial lining fluid and plasma

Poster Session 5b: Pharmacokinetics/pharmacodynamics of antibacterial drugs & therapeutic drug monitoring (incl lab methods, models, in vitro and in vivo studies)

Presenter: Valentin Al Jalali, PhD, MD

Timing: Sunday April 13, 2025; 12:00 - 13:30 pm CEST

The dose of 300mg q12h was generally safe and well tolerated. After intravenous infusion, rifabutin penetrates well into the lung and shows a very high drug concentration in the ELF.

ePoster #1523: Rifabutin MIC test strip development for susceptibility testing against Acinetobacter baumannii

Poster Session 3c: Susceptibility testing methods (incl assay validation, phenotypic assays and comparative studies, excl TB)

Presenter: Birgit Schellhorn, Senior Research Associate

Timing: Monday April 14, 2025; 12:00 - 13:30 pm CEST

Rifabutin (RBT) MTS device was successfully developed. It shows good reproducibility, good stability and good agreement to the reference agar dilution testing method. These results suggest that RBT MTS could be a valid agar diffusion method for testing RBT MIC against A. baumannii.

BV500 for non-tuberculosis mycobacterium (NTM) infections:

Top Rated ePoster #2414: In vitro activity of a BV500 lead compound against M. abscessus and other NTMs

Presentation Session 5a: Drug discovery and new compounds mechanisms of action & spectrum, preclinical data & basic pharmacology (incl drug design, investigational and non-traditional therapeutics)

Presenter: Marija Miljkovic, PhD, Research Scientist

Timing: Sunday April 13, 2025; 12:00 - 13:30 pm CEST

BV500 Leads overcomes Arr-mediated resistance in MAB allowing potent and broad spectrum NTM in vitro activity, including in macrophages, with low potential for resistance development. Together with metabolic stability and limited risk for drug-drug interactions, these data indicate the potential of the BV500 series for further development to treat NTM infections.

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 lead candidate 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 multidrug-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 ready), and tuberculosis (alpibectir, Phase 2a, 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
Hernan Levett, CFO, Tel. [phone]; Mail: [e-mail]
For Media: [e-mail]
Website: www.bioversys.com

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