BASEL, Switzerland, April 16, 2026

BioVersys AG has announced a key clinical milestone with the first patient first visit (FPFV) in its global Phase 3 RIV-TARGET trial evaluating BV100, a novel anti-infective therapy targeting hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). This pivotal study focuses on infections caused by carbapenem-resistant Acinetobacter baumannii (CRAB), a highly drug-resistant pathogen associated with high mortality rates and limited treatment options. The trial is expected to enroll approximately 300 patients across 100 sites in 15 countries, positioning it as a critical step toward global regulatory submissions planned for 2028 and reinforcing BioVersys’ leadership in tackling multi-drug resistant (MDR) infections.

Phase 3 RIV-TARGET Trial Advances Critical Study

The RIV-TARGET Phase 3 trial (NCT07326540) is designed as a randomized, active-controlled, two-part study comparing BV100 plus low-dose polymyxin B against colistin combined with high-dose ampicillin-sulbactam, representing current standard-of-care therapies. The study’s primary endpoint is 28-day all-cause mortality, a crucial measure in critically ill patients suffering from severe pneumonia. Secondary endpoints include clinical cure rates, ventilator-free days, ICU stay duration, and overall hospitalization time, providing a comprehensive evaluation of treatment effectiveness.

Notably, the trial also includes an open-label cohort for patients resistant to existing therapies, further expanding its clinical relevance. The study builds on strong Phase 2 data, where BV100 demonstrated a 50% reduction in mortality compared to best available therapy, highlighting its potential as a best-in-class antibacterial treatment.

BV100 Targets High-Priority Drug-Resistant Pathogen

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BV100 is a novel intravenous formulation of rifabutin with a unique mechanism enabling active uptake into Gram-negative bacteria, specifically targeting the Acinetobacter baumannii-calcoaceticus complex (CRABC).

This innovative approach allows effective inhibition of bacterial RNA polymerase, overcoming traditional resistance barriers. The therapy has received Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration, granting eligibility for Fast Track status, priority review, and extended market exclusivity.

With global CRAB infections exceeding one million annually and mortality rates reaching up to 50%, the need for effective therapies remains urgent. BV100’s ability to deliver significant survival benefits and strong safety profiles positions it as a promising solution in the fight against antimicrobial resistance (AMR).

Global Development Strategy and Future Outlook

The Phase 3 program is expected to complete patient enrollment by the end of 2027, with topline results anticipated within two years, supporting regulatory submissions across the U.S., Europe, and China. In parallel, BioVersys is advancing the RIV-CARE Phase 2b trial, aimed at generating real-world clinical evidence in regions with high resistance levels, with interim results expected by the end of 2026.

The company’s broader pipeline focuses on novel antibacterial therapies designed to overcome resistance mechanisms and address critical unmet medical needs. As antimicrobial resistance continues to escalate globally, innovations like BV100 represent a transformational advancement in infectious disease treatment, offering hope for improved patient outcomes in severe hospital-acquired infections.

Source: BioVersys press release