BioVersys Advances BV100 Clinical Trials in China

BioVersys AG has launched its Phase 1 clinical trial for BV100 in China. This marks the first dosing of healthy volunteers, a vital step before expanding into Chinese clinical sites for a global Phase 3 trial in late 2026. The firm is focused on developing novel antibacterial solutions for critical infections, particularly those from multi-drug resistant (MDR) bacteria.

BV100, a new rifabutin formulation, targets Acinetobacter baumannii, a major health threat in China and Asia. The incidence rates in these regions are notably high, with resistance to carbapenems reaching 60-80%. The drug, shown in Phase 2 trials, cuts mortality in critically ill patients with Ventilator Associated Bacterial Pneumonia (VABP) by half.

Consultation with regulatory bodies across Europe, the US, and China is underway. This global outreach aims to incorporate patients globally in the impending Phase 3 trial, highlighting ongoing efforts to mitigate the impact of antimicrobial resistance.