• BV100 is a potential best-in-class anti-infective agent in treating hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP) caused by carbapenem-resistant Acinetobacter baumannii (CRAB).
• The RIV-TARGET Phase 3 clinical trial (NCT07326540) aims to compare BV100 plus low-dose polymyxin B to Colistin plus high-dose ampicillin-sulbactam in patients with suspected HABP or VABP due to carbapenem-resistant Acinetobacter baumannii-calcoaceticuscomplex (CRABC).
• The start of Phase 3 follows the successful Phase 2 study that showed an overall 50% reduction in mortality compared with best available therapy. 
• Global pivotal Phase 3 trial is on track to enroll last patient by the end of 2027 and will support first regulatory approval submissions in 2028.

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 multi-drug resistant (MDR) bacteria, announced today the first patient first visit in its global pivotal Phase 3 clinical trial for BV100. The Phase 3 trial is designed to evaluate BV100 in critically ill patients with hospital-acquired or ventilator-associated bacterial pneumonia (HABP or VABP), suspected or confirmed to be due to carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). The RIV-TARGET Phase 3 global trial is expected to enroll approximately 300 patients across ~100 sites in ~15 countries.

CRABC is a highly drug-resistant Gram-negative pathogen that is recognized as a critical priority by global health authorities. BV100 is a novel intravenous formulation of rifabutin based on the newly identified mode of action for the active uptake of rifabutin into the Acinetobacter baumannii-calcoaceticus complex. BV100 is being developed for MDR hospital infections caused by Acinetobacter baumannii, including carbapenem-resistant Acinetobacter baumannii (CRAB) strains. BV100 has Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity in the US.

Dr. Glenn E Dale, Chief Development Officer of BioVersys: “CRAB resistant infections have become a major cause of death in hospital settings over the last two decades, with mortality rates reaching 50% due to limited treatment options. The halving of the mortality rate demonstrated by BV100 in its Phase 2 trial is encouraging, and we look forward to seeing the Phase 3 trial progress and potentially offer physicians and patients a new therapeutic option before the end of the decade.”

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “Achieving first patient first visit in the RIV-TARGET trial marks a significant milestone for BioVersys in the development of BV100 and more importantly for patients suffering from CRABC infections. We are very proud of the extensive work that has brought us to this point by the BV100 team, partners and clinical centres worldwide. We expect top-line Phase 3 results within the next two years. Data from this trial will be a critical part of subsequent regulatory submissions for marketing authorisations globally. In parallel, we are conducting the RIV-CARE open label Phase 2b trial to collect further safety experience and evidence of clinical efficacy in a first interim read-out towards the end of 2026. The BV100 development program intends to demonstrate best-in-class anti-infective treatment qualities for suspected HABP or VABP due to CRABC. We continue on our quest to make a difference for AMR patients afflicted with serious unmet medical needs.”

Phase 3 trial design
The global Phase 3 trial is a randomized, active-controlled two-part parallel-group trial to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP suspected or confirmed to be due to CRABC infection (RIV-TARGET). Part A is the pivotal, randomized, comparative portion of the trial, employing a partially blinded design aiming to enroll approximately 300 HABP/VABP patients with suspected or confirmed CRABC infections. Patients will be randomized 1:1 to receive either [1] BV100 combined with low-dose polymyxin B or [2] Colistin combined with high-dose ampicillin-sulbactam, with both arms allowing meropenem as background in case of polymicrobial infections. The primary efficacy endpoint is defined as 28-day all-cause mortality (ACM) in the CRABC microbiological modified intention-to-treat (CRABC m-MITT) population. Secondary efficacy endpoints will include clinical cure status at the test of cure (ToC) in CRABC m-MITT, ventilator free days, time spent in intensive care unit (ICU) and time in hospital. As part of the study protocol, data safety monitoring boards (DSMBs)¹ will be convened at regular intervals to review trial progress.

The Phase 3 trial also includes an open-label, non-randomized, additional single group (Part B) to evaluate the efficacy and safety of BV100 plus low-dose polymyxin B in patients with HABP or VABP due to CRABC known to be resistant to colistin or polymyxin B prior to study entry and patients for whom colistin or polymyxin B regimen has failed prior to study entry. Approximately 25 patients are expected to be enrolled in Part B.

This pivotal Phase 3 trial follows the successful completion of a Phase 2 trial in documented Acinetobacter baumannii VABP patients. BV100 combined with polymyxin B demonstrated a clear survival benefit, resulting in a 50% relative reduction in 28-day ACM compared with best available therapy (BAT), in VABP patients suffering from confirmed CRAB infections (28-day ACM: 60% for BAT vs 25% for BV100), and was generally safe and well tolerated. The current Phase 3 trial mimics the successful study design of the positive Phase 2 trial and is expected to read-out towards the end of 2027. Subsequent regulatory submissions aimed at commercial approval are planned in 2028 initially for the US, Europe and China.

In parallel to the Phase 3 pivotal trial, an open-label Phase 2b differentiation trial (RIV-CARE) will be initiated in H1 2026 comparing BV100 with BAT in multiple geographies. The Phase 2b trial aims to provide real world evidence of clinical practices in settings with very high drug resistance levels. Interim analysis is planned for the end of 2026.