공시 • May 03
Bioversys Ag Approves Election of Simona Skerjanec as Members of the Board of Directors BioVersys AG announced at the AGM held on April 30, 2026, approved election of Ms. Simona Skerjanec as Members of the Board of Directors. 공시 • Apr 17
BioVersys AG Announces First Patient First Visit In HABP/VABP Pivotal Phase 3 RIV-TARGET Trial Of BV100 BioVersys AG announced 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 approximately 100 sites in approximately 15 countries. 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. 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-calcoaceticus complex (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. 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 BV100 combined with low-dose polymyxin B or 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) 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 First Half 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. 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. 공시 • Apr 16
Bioversys AG Presents Data on Clinical and Preclinical Pipeline Programs At ESCMID Global 2026 BioVersys AG announced its participation in the 36th Congress of the European Society of Clinical Microbiology & Infectious Diseases (ESCMID Global 2026), where it will present the latest preclinical data on its lead clinical asset BV100 (CRABC) and its preclinical asset BV500 (NTM). Poster presentations to feature data from clinical asset BV100 addressing carbapenem-resistant Acinetobacter baumannii-calcoaceticus complex (CRABC) hospital infections and preclinical asset BV500 addressing non-tuberculosis mycobacteria (NTM) infections. Experts from the UK, Greece and Switzerland to share preclinical insights on BV100’s activity against CRABC on Sunday, April 19, 2026. BioVersys’ CEO, Marc Gitzinger, to present at a session exploring how funding and policy priorities shape infectious disease research and antibiotics innovation on Monday, April 20, 2026. ESCMID is the premier annual congress of the European Society of Clinical Microbiology and Infectious Diseases. It takes place from April 17 - 21, 2026 in Munich, Germany. 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 (ABC). It is currently being studied in a global Phase 3 clinical trial (RIV-TARGET), with the potential to be a 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). BV100 has Qualified Infectious Disease Product (QIDP) Designation from the U.S. FDA, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity. BV500 is derived from the company’s proprietary Ansamycin Chemistry platform and a successful collaboration within the SmartLab public-private partnership with the University of Lille (France). BioVersys’ research teams in Lille (France) and Basel (Switzerland) have identified and developed several advanced, highly potent and orally bioavailable Lead candidates, with broad-spectrum in vitro and in vivo anti-NTM activity, which are devoid of cross-resistance with other therapeutic classes. The BV500 program has received funding support and access to key expertise from the CF AMR Syndicate and the EU IHI funded RespiriNTM program. BV500 is under a global research collaboration and exclusive license option agreement with the Japanese pharmaceutical company, Shionogi & Co. Ltd. In vitro results suggest BV100 remains active against drug-resistant A. baumannii, including isolates with common rpoB resistance mutations. In vitro infection model-based studies show BV100 combinations (with polymyxin B or cefiderocol) can increase bacterial killing and may help limit resistance in tested strains. Preclinical data show BV500 Lead compounds are active against non-tuberculous mycobacteria (including M. abscessus) both in vitro and in vivo. 공시 • Apr 13
Bioversys Ag Publishes Pre-Clinical Data of Alpe Drug Combination in Nature Communications BioVersys AG announced the publication of pre-clinical data in the journal of Nature Communications, for its anti-tuberculosis combination AlpE. Alpibectir, a small molecule acting through a novel mode of action, represents a new concept of overcoming drug-resistance in M. tuberculosis, by potentiating the activity of an existing antibiotic, ethionamide, and was identified in a research collaboration with GSK and the academic groups of Dr. Alain Baulard, Prof. Benoit Deprez and Prof. Nicolas Willand. Following the recently published clinical proof-of-concept for AlpE in pulmonary TB, BioVersys and collaborators now publish pre-clinical evidence supporting the potential of AlpE to provide a new therapeutic option to treat tuberculosis. in vitro studies, AlpE showed potent activity against a diverse set of M. tuberculosis clinical strains, including those resistant to standard of care treatments. AlpE was also active against intracellular M. tuberculosis. in vivo studies, AlpE rapidly reduced bacterial load levels and improved survival, demonstrating clear translation from in vitro to in vivo proof of concept. Through the BioVersys and GSK partnership, alpibectir has completed Phase 1 and two Phase 2a pulmonary TB trials and is considered to be generally safe and well tolerated. Currently, AlpE is being studied in a pulmonary TB Phase 2b trial in combination with first-line TB drugs (NCT05807399), within IMI2 UNITE4TB project and BioVersys recently initiated a Phase 2 trial in meningeal TB (NCT07350174). Alpibectir (previously known as BVL-GSK098) is a small molecule developed from BioVersys’ Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a collaboration with GSK, the Institut Pasteur de Lille and the University of Lille. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance. The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity. Ethionamide (Eto) and prothionamide (Pto) are recommended by the World Health Organization (WHO) for use as second-line agents in the treatment of drug-resistant pulmonary TB and TB meningitis. Despite their usefulness as TB drugs, Eto/Pto cause dose-dependent adverse events that negatively impact treatment adherence. Eto/Pto are prodrugs and their antibacterial activity can be linked to the level of bioactivation inside Mycobacterium tuberculosis (Mtb). The clinical candidate alpibectir (formerly BVL-GSK098) acts on transcriptional regulators of Mtb, stimulating novel bioactivation pathways for Eto, that has resulted in an observed increase of Eto efficacy, while simultaneously overcoming Eto resistance and keeping potent activity on MDR strains, including to a vast majority of isoniazid-resistant strains. BVL-GSK098 renders Eto rapidly bactericidal and reduces the emergence of Eto resistance development in vitro and in vivo. Based on pre-clinical data, the TRIC-TB project started to explore whether BVL-GSK098 could ultimately, lower the efficacious human oral dose of Eto by at least 3-fold, minimize dose-dependent side effects, and support patient compliance. With the completion of Phase 1 a major milestone of the TRIC-TB Project was achieved and a novel, fast acting TB agent with the potential to replace isoniazid in TB therapy has been brought into clinical development. 
