Basel, Switzerland. September 2, 2026, 7am CEST
• Fast-Track Designation supports the urgent need for novel and innovative antimicrobials for the treatment of serious infections caused by gram-negative bacteria.
• 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-calcoaceticus complex (CRABC).
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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to BV100 under the Qualified Infectious Disease Product (QIDP) designation for the Company’s lead clinical asset, currently undergoing a Phase 3 study.
The Fast Track designation is granted to BV100 for the treatment of ventilator-associated bacterial pneumonia (VABP) and hospital-acquired bacterial pneumonia (HABP) caused by carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC). With the Fast Track designation, BioVersys can benefit from more frequent interactions with the FDA, increased communication on clinical trial design and data requirements, and eligibility for rolling review.
BV100 is a novel intravenous formulation of the antibiotic rifabutin developed to target severe CRABC infections. BV100 possesses a novel mode of action via uptake via the siderophore pathway in Acinetobacter, providing a much-needed novel non-β-lactam therapy for this infection.
Dr. Marc Gitzinger, CEO of BioVersys, said: “We are pleased that the US FDA has granted Fast Track designation to BV100, our lead clinical asset. This designation underscores the significant unmet medical need for new treatment options for patients suffering from serious infections caused by multidrug-resistant Acinetobacter baumannii and supports our efforts to bring BV100 to patients as efficiently as possible."
BV100 is currently studied in two clinical trials: the pivotal Phase 3 global registrational trial, RIV-TARGET and the open-label Phase 2b differentiation trial, RIV-CARE in collaboration with ADVANCE-ID. These studies follow the successful Phase 2 study that showed BV100 had an overall 50% reduction in mortality compared with best available therapy. In 2019, BV100 received the Qualified Infectious Disease Product (QIDP) Designation by the U.S. FDA.
CRABC is a major cause of healthcare-associated infections and one of the most challenging multidrug-resistant pathogens to treat, with mortality rates reaching 50% globally. It is a WHO priority-1 critical pathogen.
About BioVersys
BioVersys AG is a multi-asset, clinical stage biopharmaceutical company focused on identifying, developing and commercializing novel antibacterial products for serious life-threatening infections caused by multi-drug resistant (“MDR”) bacteria. Derived from the company’s two internal technology platforms (TRIC and Ansamycin Chemistry), candidates are designed and developed to overcome resistance mechanisms, block virulence production and directly affect the pathogenesis of harmful bacteria towards the identification of new treatment options in the antimicrobial and microbiome fields. This enables BioVersys to address the high unmet medical need for new treatments against life-threatening resistant bacterial infections and bacteria-exacerbated chronic inflammatory microbiome disorders. The company’s most advanced research and development programs address nosocomial infections of Acinetobacter baumannii (BV100, Phase 3), and tuberculosis (alpibectir, Phase 2, in collaboration with GlaxoSmithKline (GSK) and a consortium of the University of Lille, France). BioVersys is located in the biotech hub of Basel, Switzerland.
About FDA Fast Track Designation
Fast Track is an FDA programme intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. The designation enables closer communication between sponsors and the FDA throughout the development process and may support earlier availability of important new therapies for patients. More information is available on the FDA website.
About BV100
BV100 is a novel formulation of rifabutin suitable for intravenous administration, with a recently discovered novel mode of action showing an active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii. For the first time, BV100 allows for the targeting of the RNA-polymerase enzyme in Gram-negative bacteria with a human-suitable dose. BV100 is being developed for the treatment of infections caused by Acinetobacter baumannii calcoaceticus complex (ABC), including carbapenem-resistant ABC (CRABC) in critically important indications of ventilator associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI). BV100 was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.
About Acinetobacter baumannii
Acinetobacter baumannii calcoaceticus complex (ABC) are Gram-negative bacteria found in the environment (e.g., in soil and water) and an opportunistic pathogen in humans, typically infecting critically ill and immunocompromised patients, that can result in severe pneumonia and bloodstream infections in addition to affecting other parts of the body. ABC is considered a significant worldwide threat in the healthcare setting given its ability to survive for prolonged periods on surfaces, combined with its ability to develop or acquire resistance to standard of care antibiotics, e.g. carbapenems. Carbapenem-resistance as well as multi-drug resistance (MDR) rates for ABC are among the highest recorded for any bacteria in current times (The Lancet 2022; 399: 629–55). Incidence and resistance rates for ABC are trending upwards and COVID-19 has exacerbated this significantly. BioVersys forecasts the annual number of carbapenem-resistant A. baumannii infections in hospitals to have surpassed one million globally and due to the limited treatment options, such infections come with high (up to 50%) mortality rates.
