Clinical Trials
10
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2008
Completed
8
80.0%
Not yet recruiting
2
20.0%
No approval data available
- The U.S. FDA granted Fast Track Designation to BV100, BioVersys' lead clinical asset, for treating VABP and HABP caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). - BV100 is a novel intravenous formulation of rifabutin that uses the siderophore pathway to target the RNA-polymerase enzyme in Gram-negative bacteria, offering a non-β-lactam therapy option. - The designation follows a Phase 2 study showing a 50% reduction in mortality versus best available therapy, with BV100 now in a pivotal Phase 3 trial (RIV-TARGET). - CRABC is a WHO priority-1 critical pathogen with mortality rates reaching 50% globally, underscoring the urgent unmet medical need for new antimicrobials.
- BioVersys has dosed the first healthy volunteer with BV100 in a mandatory Phase 1 clinical trial in China, marking a crucial step toward addressing the country's severe antimicrobial resistance burden. - The novel intravenous rifabutin formulation demonstrated promising Phase 2 results by halving mortality rates in critically ill patients with carbapenem-resistant Acinetobacter baumannii infections compared to best available therapy. - Chinese clinical sites will be included in the global Phase 3 registration trial by late 2026, targeting over 1 million patients annually at risk of severe CRAB infections in China alone. - BV100 represents a breakthrough treatment for multidrug-resistant hospital infections, with Acinetobacter baumannii being the leading cause of antimicrobial resistance deaths in China.
- BioVersys AG received European Medicines Agency orphan designation for alpibectir combined with ethionamide to treat tuberculosis, following successful Phase 2a proof of concept trials. - The designation provides key regulatory incentives including reduced fees, clinical protocol support, and 10-year EU market exclusivity for this novel resistance-overcoming approach. - Alpibectir represents a new therapeutic concept that significantly potentiates existing antibiotic ethionamide activity, addressing the critical need for MDR-TB treatments. - The combination is currently being studied in Phase 2 trials for pulmonary TB, with meningeal TB trials anticipated to begin in early 2026.
• BioVersys has been granted key patent protection in China for BV100, a novel intravenous rifabutin formulation targeting deadly Acinetobacter baumannii infections with mortality rates up to 50%. • The patent expansion to China is strategically significant as the country faces particularly high incidence of Acinetobacter infections with resistance rates of 60-80%, affecting over 1 million patients annually. • BioVersys plans to initiate Phase 1 trials in China soon, followed by inclusion in global Phase 3 registration trials in H2 2025, targeting a global peak sales potential of USD 800 million.
