- BV100: successful end of Phase 2 meeting with US FDA following Positive Phase 2 read-out in Ventilator-Associated Bacterial Pneumonia (VABP); Phase 3 on track to initiate in 2025; Formulation patent granted in China, extending BV100 IP protection to over 25 countries, including the US, Europe and the UK
- Alpibectir: First patient dosed in a Phase 2 combination trial in pulmonary Tuberculosis by partner GSK – first top line data expected in Q2 2026; EMA Orphan Designation received for Alpibectir and ethionamide combination for the treatment of tuberculosis
- BV500: Entered into Global Research Collaboration and exclusive license agreement with Shionogi to jointly develop a broad-spectrum non-tuberculous mycobacteria (NTM) clinical candidate
- Improved FY 2025 Financial Guidance with CHF 29m in expected Operating Loss and CHF 78m in Cash & Cash equivalent – Company funded into 2028
BASEL, Switzerland, Sept. 10, 2025 (GLOBE NEWSWIRE) — BioVersys AG, 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 its financial results and corporate highlights for the first half year 2025. The company will host a conference call and webcast on September 10, 2025 at 2:00 PM CET / 8:00 AM ET where management will review the financial results, provide a business update and outlook. To participate in the call please register under the following link: Registration Link
Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “The first half of 2025 started with the successful IPO on the SIX Swiss Exchange in February with proceeds allowing us to advance our entire pipeline until early 2028. We are currently preparing to initiate the Phase 3 program for BV100 in VABP in 2025. We also recently announced a landmark research and licensing agreement with Shionogi for BV500, initiated an additional Phase 2 trial for alpibectir in pulmonary Tuberculosis together with our partner GSK and received EU orphan designation for alpibectir. We look forward to generating value-adding impact in the fight against anti-microbial resistance and creating significant shareholder value.”
Pipeline Highlights
BV100 (rifabutin for infusion) for carbapenem resistant Acinetobacter baumannii infections:
As announced in April 2025, the key data from the Phase 2 Ventilator Associated Bacterial Pneumonia (VABP) clinical trial for BV100 were presented at the 2025 Congress of the European Society of Clinical Microbiology and Infectious Diseases (ECSMID). BV100 demonstrated strong signs of efficacy by halving the mortality rate in critically ill patients suffering from carbapenem resistant Acinetobacter baumannii infections compared with best available therapy. Besides the strong efficacy, BV100 was also generally safe and well tolerated. In Part B of the Phase 2 trial, BV100 also proved effective in patients failing best available therapy and those suffering from totally drug-resistant infections. A webcast featuring two internationally renowned key opinion leaders reviewing the data is available here.
Preparations for a global Phase 3 investigating BV100 for the treatment of VABP are progressing well following a successful end of Phase 2 meeting with the US FDA, leading to an aligned Phase 3 study design. The planned study will enroll approximately 250 evaluable patients with ventilator associated bacterial pneumonia (VABP)/hospital-acquired bacterial pneumonia (HABP) or bloodstream infections (BSI), to be randomized 1:1. The study arm for BV100 will be similar in dose and background medicines as during the Phase 2 trial randomized to a Colistin based control arm. The first patient first visit is anticipated for the end of 2025.
Preparations for the planned Phase 2b trial are also on track and a first patient first visit is anticipated for Q1 2026. The Phase 2b trial is designed to enroll a similar patient population, randomizing to best available therapy and exploring additional combination drugs for BV100 with a goal to generate real world evidence around best clinical practice, intended to provide valuable efficacy data to physicians and compare these data to what they observe in their daily practice. The Phase 2b aims to enroll 90 patients in a 2:1 randomization and is designed to also show additional clinical differentiation for BV100 by recruiting in populations where the infecting Acinetobacter baumannii is resistant to even the newest approved drugs.
Both Phase 3 and Phase 2b trials will include a Part B, allowing to recruit totally drug-resistant patients and enabling access to BV100 as rescue therapy.
Besides progress on the clinical development for BV100, the key composition of matter patent of the formulation of BV100 was also granted in China and is now granted in over 25 jurisdictions globally.
Alpibectir in pulmonary and meningeal Tuberculosis (in partnership with GSK):
Alpibectir is being developed in combination with Ethionamide (AlpE) together with our partner GSK. In Q1 2025, GSK initiated a Phase 2 early bactericidal activity trial for AlpE in combination with first-line TB drugs in pulmonary tuberculosis. This trial is run within UNITE4TB, a European Union and European Pharmaceutical funded Innovative Medicines Initiative (IMI2) Joint Undertaking. The trial is recruiting well and remains on track to report top line data by Q2 2026. A Phase 2 trial in meningeal tuberculosis to be led by BioVersys alongside a French and African academic consortium is planned to initiate in Q1 2026.
As reported earlier this year, the combination of Alpibectir and Ethionamide (AlpE) was also granted orphan designation from the European Medicines Agency (EMA). This recognition is based on strong proof of concept data from the Phase 2a data and the potential to address highly drug-resistant TB …