TRIAL TO BE CONDUCTED BY ADVANCE-ID, A NATIONAL UNIVERSITY OF SINGAPORE LED TRIAL NETWORK, IN PARTNERSHIP WITH BIOVERSYS
Ad hoc announcement pursuant to Art. 53 LR
BASEL, Switzerland, Nov. 10, 2025 (GLOBE NEWSWIRE) --
- Panel of independent experts selected BioVersys’ BV100 out of 24 candidates to participate in the ADVANCE-ID and National University of Singapore (NUS) Asia clinical trial network of 130 sites across 35 countries
- Wellcome funds ADVANCE-ID/NUS with SGD 22 million (c. CHF 14 million) to conduct their first Sponsor (BioVersys) driven Phase 2 trial
- Non-dilutive funding received for the trial strengthens BioVersys’ cash position and extends the company’s cash runway further into 2028
- This partnership allows the BV100 Phase 2b open-label study to increase patient size to 90 patients with an interim data read-out expected in H2 2026
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 multidrug-resistant (MDR) bacteria, announced today that its lead asset BV100, an innovative anti-infective developed for hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB), has been selected to participate in the ADVANCE-ID clinical trial network which has its hub at the Saw Swee Hock School of Public Health, National University of Singapore. BV100 was selected by an independent expert panel out of 24 applications to be awarded this Phase 2b support.
BioVersys had announced its plan to conduct a Phase 2b study in parallel to the upcoming Phase 3 study in order to generate additional clinical data to support the future BV100 new drug application, collect additional clinical evidence in real world settings in countries with very high drug resistance levels and allow the comparison with some of the newest approved drugs.
This Phase 2b will now be conducted by the ADVANCE-ID clinical trial network in several countries in Southeast Asia, in settings with very high levels of drug-resistant infections and in close collaboration with BioVersys. This Phase 2b study has been made possible thanks to the generous contribution of Wellcome who strengthened the ADVANCE-ID network with SGD 22 million (c. USD 17m or CHF 14m), enabling the first sponsor driven clinical trial run by ADVANCE-ID in close collaboration with an industry sponsor, BioVersys. In addition to significantly reducing the financial cost to BioVersys, conducting the Phase 2b in partnership with the ADVANCE-ID clinical trial network increases the number of treatment arms from two to three treatment arms, including two arms for BV100 combined with either Ceftazidime/avibactam or with Cefiderocol, and one arm for Best Available Therapy. Consequently, the total number of evaluable patients increases from 60 patients to 90 patients in Part A, compared to the initial Phase 2b development plan. This Phase 2b will enroll patients with VABP/HABP and BSI suffering from CRAB (Part A), and patients with CRAB ventriculitis and meningitis (Part B, additional 10 patients).
Professor David Paterson, Director of ADVANCE-ID: “Carbapenem-resistant Acinetobacter baumannii (CRAB) has been classified as a “Critical” priority pathogen by WHO since 2017. BV100 is an attractive anti-infective which has already delivered very promising results in a Phase 2 VABP trial and we are very happy with the choice made by our independent expert panel. We look forward to collaborating with BioVersys, with our clinical trial network providing the infrastructure, expertise and access to a large population of patients with life-threatening CRAB infections. These are exactly the patients who need the kind of innovative anti-infective potential that BV100 represents.”
This Phase 2b open label randomized trial is expected to dose the first patient in H1 2026 and to include an interim data read-out in H2 2026. The data generated are expected to contribute to the BV100 Phase 3 program aimed at regulatory submission in the US, Europe and China.
The mission of ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) is to conduct high-quality clinical trials that globally impact the management of infections. The network has already conducted clinical research in over 10,000 patients including over 3,000 in Ventilator Associated Bacterial Pneumonia (VABP) and Hospital Acquired Bacterial Pneumonia (HABP) and over 7,000 in Blood Stream Infections (BSI), finding that carbapenem-resistant Acinetobacter baumannii was the most common cause of these life-threatening infections across Asia. Wellcome originally supported the ADVANCED-ID set-up with funding in 2022 and has now provided a further 22 million SGD contribution to build clinical trial capacity and support this first Sponsor driven Phase 2 trial.
Alex Pym, Director of Infectious Disease at Wellcome: “To ensure new antibiotics work where they’re needed most, it’s essential they are tested in the countries with the highest levels of antimicrobial resistance (AMR). It’s very exciting to see this trial for a first-in-class new antibiotic being tested in the Southeast Asia region - one of the hardest hit by drug resistance, as highlighted in the WHO GLASS report. This will be vital to ensuring an equitable, effective approach to tackling the growing global threat of AMR.
ADVANCE-ID, through fostering collaboration between academics, clinicians, and industry can accelerate innovation as well as building our capacity to reduce the impact of AMR worldwide, ultimately getting effective treatments to the communities and regions where they can have the biggest impact.”
Dr. Glenn Dale, Chief Development Officer of BioVersys: “We are delighted that BV100 was selected by ADVANCE-ID to participate in their clinical trial network in Asia and for the outstanding commitment and support that Wellcome continues to show globally in the advancement of medicines addressing unmet human health challenges. BV100 has already demonstrated in its first Phase 2 trial the potential for a significant mortality benefit for patients with life-threatening CRAB infections. In this next Phase 2b trial, we aim to show a benefit over any currently available drug in real world conditions, which will provide further evidence of the value of BV100 to patients and health care systems. We are excited to collaborate with Professor Paterson and his team. This Phase 2b trial will add additional data to our global Phase 3 trial that is currently being initiated.”
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 multidrug-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. The WHO list CRAB as “critical” in the highest priority group. 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.
About ADVANCE-ID
ADVANcing Clinical Evidence in Infectious Diseases (ADVANCE-ID) is a clinical research network involving more than 50 hospitals across Asia, with a base at the National University of Singapore (NUS). The mission of ADVANCE-ID is to conduct high-quality clinical trials that have a global impact on management of infections. ADVANCE-ID was set up in March 2022 with a grant from Wellcome and funds from other institutions including, NUS Saw Swee Hock School of Public Health, NUS Yong Loo Lin School of Medicine, Duke-NUS Medical School, NTU Lee Kong Chian School of Medicine, and the National Centre for Infectious Diseases.
Email: hello@advance-id.network Tel : +65 6516 4988 https://www.advance-id.network/
About National University of Singapore (NUS)
The National University of Singapore (NUS) is Singapore’s flagship university, which offers a global approach to education, research and entrepreneurship, with a focus on Asian perspectives and expertise. We have 15 colleges, faculties and schools across three campuses in Singapore, with more than 40,000 students from 100 countries enriching our vibrant and diverse campus community. We have also established more than 20 NUS Overseas Colleges entrepreneurial hubs around the world.
Our multidisciplinary and real-world approach to education, research and entrepreneurship enables us to work closely with industry, governments and academia to address crucial and complex issues relevant to Asia and the world. Researchers in our faculties, research centres of excellence, corporate labs and more than 30 university-level research institutes focus on themes that include energy; environmental and urban sustainability; treatment and prevention of diseases; active ageing; advanced materials; risk management and resilience of financial systems; Asian studies; and Smart Nation capabilities such as artificial intelligence, data science, operations research and cybersecurity.
For more information on NUS, please visit nus.edu.sg.
About Wellcome
Wellcome supports science to solve the urgent health challenges facing everyone. We support discovery research into life, health and wellbeing, and we’re taking on three worldwide health challenges: mental health, infectious disease and climate and health.
Email: mediaoffice@wellcome.org Tel: +44 (0)20 7611 8866, https://wellcome.org
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.
BioVersys contact
Hernan Levett, CFO, Tel. +41 61 633 22 50; Mail: Hernan.levett@bioversys.com
For Media: media@bioversys.com
www.bioversys.com
Disclaimer
This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning BioVersys and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of BioVersys to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. BioVersys is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise.
