Bioversys Concludes BV100 Phase 2 Trial in VABP and Shares Business Update

BioVersys AG, a biopharmaceutical company based in Basel, Switzerland, has announced the completion of the final patient visit in its Phase 2 clinical trial for its lead product, BV100. This trial focuses on BV100, a new formulation of rifabutin designed for intravenous use, aimed at treating serious hospital infections, specifically ventilator-associated bacterial pneumonia (VABP) caused by Carbapenem-Resistant Acinetobacter baumannii (CRAB).

The Phase 2 open-label, randomized, and active-controlled study assessed BV100's pharmacokinetics, safety, and efficacy in adult patients with VABP. Preliminary data indicates that the primary endpoint was successfully met, confirming BV100’s general safety and tolerability. The study revealed promising signs of efficacy in treating VABP patients with confirmed CRAB infections. Mortality rates were significantly lower in the BV100 treatment group compared to the control group receiving the best available therapy. Specifically, the 14-day and 28-day all-cause mortality (ACM) rates for BV100 were 12.5% and 25%, respectively, compared to 40% and 60% in the control arm. Full top-line results are expected in early 2025 after complete data analysis.

BV100 operates through a newly discovered mode of action, enabling the active uptake of rifabutin into Acinetobacter baumannii. It is being developed to address the severe lack of effective and safe treatments for CRAB infections, which carry high mortality rates in hospitals, sometimes reaching 50%. Recognized as a priority pathogen by the World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC), CRAB presents a significant challenge with over one million hospital-treated patients potentially benefiting from BV100 across various regions.

BioVersys plans to advance BV100 into a global Phase 3 registration trial, anticipated to start in the latter half of 2025. To date, BV100 has been administered to over 230 subjects in doses up to 900 mg over 14 days in clinical trials, demonstrating consistent safety and tolerability. The comprehensive clinical data, including the Phase 2 trial in VABP patients, supports the progression of BV100 into final clinical testing phases.

Dr. Glenn E. Dale, BioVersys' Chief Development Officer, expressed satisfaction with the progress made in the clinical evaluation of BV100 and looks forward to finalizing the data for a planned Phase 3 study. Prof. David Paterson highlighted the potential of BV100 to address unmet needs in treating carbapenem-resistant infections, emphasizing its safety profile and efficacy.

In addition to BV100, BioVersys’ second key asset, alpibectir, completed a Phase 2a trial earlier this year. Alpibectir, developed in collaboration with GSK, has shown a proof of concept in tuberculosis patients, proving to be generally safe and well-tolerated. Continued development of alpibectir will proceed in close partnership with GSK.

In 2024, BioVersys expanded its strategic collaboration with GSK and extended its Series C round by CHF 14.7 million. This was further bolstered by a strategic investment from Guangzhou Sino-Israel Bio-Industry Investment Fund 2 LLP (GIBF) amounting to approximately CHF 5.17 million. This investment will facilitate the development of BV100 in China with a Phase 1 study expected to commence in the first half of 2025, in preparation for a global Phase 3 registration study.

Dr. Marc Gitzinger, CEO and founder of BioVersys, expressed optimism about the progress made in 2024, highlighting the potential of BV100 in treating severe drug-resistant bacterial infections. He emphasized the company's commitment to collaborating with regulatory authorities to expedite the Phase 3 development of BV100 and the ongoing development of their pre-clinical pipeline, including BV200 and BV500.

BioVersys, through its innovative antibacterial products, aims to address the urgent need for new treatments for life-threatening infections caused by multi-drug resistant bacteria. The company remains dedicated to bringing new treatment options to patients in need, leveraging its advanced research and development programs.