BioVersys AG, a clinical-stage biopharmaceutical company focused on tackling Multi-Drug Resistant (MDR) bacterial infections, has received confirmation from the US Food and Drug Administration (FDA) to proceed with enrolling US patients in its global Phase III RIV-TARGET clinical trial.

The pivotal study will evaluate BV100, an investigational intravenous formulation of rifabutin, in patients suffering from hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). This pathogen is recognised globally as a critical priority due to its high resistance to existing antibiotics and its role in severe hospital infections.

BV100 is designed using a novel mechanism that enables active uptake of rifabutin into Gram-negative bacteria, offering a new approach to treating infections that are increasingly difficult to manage. The drug has already received Qualified Infectious Disease Product (QIDP) designation from the FDA, making it eligible for priority review, Fast Track status and extended market exclusivity upon approval.

The Phase III RIV-TARGET trial is a randomised, active-controlled study expected to enroll around 300 patients in its primary segment. It will assess the efficacy and safety of BV100 in combination with low-dose polymyxin B compared to standard therapies. The primary endpoint focuses on reducing 28-day all-cause mortality in patients with confirmed CRABC infections, while secondary endpoints include clinical cure rates, ICU stay duration and ventilator-free days.

An additional open-label segment will evaluate BV100 in patients with infections resistant to existing last-line treatments such as colistin. The trial builds on encouraging Phase II results, where BV100 demonstrated a significant survival benefit and a strong safety profile in patients with ventilator-associated pneumonia caused by resistant strains.

BioVersys aims to complete the global Phase III trial by 2027, with regulatory submissions planned across key markets including the US, Europe and China by 2028. In parallel, the company is preparing to initiate a Phase IIb study (RIV-CARE) in 2026 to generate real-world evidence in high-resistance settings.

The development of BV100 comes at a critical time, as global health systems face rising cases of drug-resistant infections. Acinetobacter baumannii, commonly found in hospital environments, disproportionately affects critically ill and immunocompromised patients and is associated with mortality rates of up to 50 percent due to limited treatment options.

With this latest regulatory milestone, BioVersys strengthens its position in the fight against antimicrobial resistance, aiming to deliver a much-needed therapeutic option for life-threatening hospital infections worldwide.