BioVersys AG has announced the completion of the last patient's final visit in its Phase 2 clinical trial of BV100, a novel intravenous formulation of rifabutin, for the treatment of ventilator-associated bacterial pneumonia (VABP) caused by Carbapenem-Resistant Acinetobacter baumannii (CRAB). Preliminary results from the trial indicate that BV100 is generally safe and well-tolerated, demonstrating strong initial signs of efficacy in VABP patients.
The Phase 2 multicenter, open-label, randomized, active-controlled study assessed the pharmacokinetics, efficacy, and safety of BV100 in adult patients with suspected or confirmed CRAB-related VABP. The primary endpoint was met, with BV100 achieving expected pharmacokinetic targets and showing promising efficacy signals. In Part A of the study, the 14- and 28-day all-cause mortality (ACM) for BV100 was 12.5% and 25%, respectively, compared to 40% and 60% in the best available therapy control arm for patients with carbapenem-resistant Acinetobacter infections. Similar trends were observed in test-of-cure and microbiological endpoints. Full top-line results are expected in early 2025.
Addressing a Critical Unmet Need
CRAB infections pose a significant threat in hospital settings, with mortality rates reaching as high as 50%. The World Health Organization (WHO) and the Centers for Disease Control and Prevention (CDC) have designated CRAB as a priority pathogen due to the limited availability of effective and safe treatment options. BioVersys estimates that over one million hospital-treated patients in the United States, Europe, the Middle East, and China could benefit from BV100, given the high unmet need and current carbapenem resistance rates in Acinetobacter baumannii.
Clinical Development and Future Plans
BioVersys is committed to advancing BV100 into a global Phase 3 registration trial, expected to commence in the second half of 2025. To date, BV100 has been administered to over 230 subjects in Phase 1 and 2 clinical trials, with doses up to 900 mg over periods of up to 14 days, and has been generally well-tolerated. The company believes the comprehensive clinical data package supports the progression of BV100 into the final clinical phase.
Dr. Glenn E. Dale, Chief Development Officer of BioVersys, stated, "We are making great progress with our clinical evaluation of BV100, and we are very pleased to have met this latest milestone... We are now looking forward to finalizing the data ahead of our planned readout early next year."
Alpibectir Update
BioVersys' second clinical asset, alpibectir, a first-in-class molecule for tuberculosis developed in partnership with GSK, completed a Phase 2a clinical trial earlier this year. Alpibectir demonstrated proof of concept in patients and was also shown to be generally safe and well-tolerated. Development will continue in collaboration with GSK.
Strategic Investment
In May 2024, BioVersys expanded its strategic collaboration with GSK and extended its Series C round by CHF 14.7 million. This was further supported by a strategic investment of US$ 6 million from Guangzhou Sino-Israel Bio-Industry Investment Fund 2 LLP (GIBF), facilitating the extension of BV100's development to China. A Phase 1 study in China is anticipated to begin in the first half of 2025 as part of preparations for a global Phase 3 registration study.
Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys, commented, "Our lead asset BV100 holds a lot of promise towards treating patients with very severe, drug-resistant bacterial infections, with limited or no treatment options... We remain committed to bringing new treatment options for drug-resistant infections to patients in dire need."
