NEWS | BEAM Alliance


BioVersys announces first patient dosed in Phase 2 clinical trial with BV100

Basel, Switzerland. May 9, 2023, 9am CET

BioVersys AG, a privately-held clinical stage, multi-asset Swiss pharmaceutical company focusing on research and development of small molecules for multidrug-resistant bacterial infections with applications in antimicrobial resistance (AMR) and targeted microbiome modulation, announced today, that the first patient has been dosed in a multicenter Phase 2 clinical trial with BV100.

BV100 is a novel formulation of rifabutin suitable for intravenous administration. BV100 is based on the newly identified mode of action for active uptake of rifabutin into Acinetobacter baumannii-calcoaceticus complex, thus rendering the bacteria hypersensitive to rifabutin. BV100 is being developed for hospital infections caused by Acinetobacter baumannii, including carbapenem resistant strains (CRAB), which ranks on the highest priority of the WHO and CDC list of priority pathogens. There is a serious lack of effective and safe treatment options for CRAB infections and mortality rates in the hospital can be as high as 50%.

-BV100 is being studied in a multicenter, open label, randomized, active controlled, Phase study to evaluate the pharmacokinetics, efficacy, and safety of BV100 in adult patients with ventilator associated bacterial pneumonia (VABP) suspected or confirmed to be due to CRAB.
-BV100 was already shown in Phase 1 clinical trials to be generally safe and well tolerated with favorable pharmacokinetic profile in single and multiple ascending dose studies, as well as in a study in patients with varying degrees of renal impairment.

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “Following the promising safety profile shown in Phase 1, we are delighted to be testing BV100 for the first time in patients in Phase 2. The study will look at the efficacy, safety, tolerability and in particular the pharmacokinetics of BV100, in VABP patients with suspected or confirmed CRAB infection.”

Prof. Apostolos Armaganidis, MD, Attikon University Hospital, Athens: “As a long time clinician of pulmonary and intensive care medicine in Athens, I have been witness to high levels of Acinetobacter baumannii drug-resistance. During the COVID-19 pandemic the situation worsened and even Colistin, often the only working and last resort antibiotic, faced as much as 60-70% resistance. Therefore, I am very encouraged to see BV100 being tested in VABP patients for the first time, and the promise it brings of a new lifesaving therapeutic treatment option for CRAB patients.”

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “Moving BV100 into Phase 2 is an important next step in developing our pipeline of pathogen-focused products against the highest priority bacterial infections, targeting the most important health threats. Our two lead assets are now in Phase 2 clinical trials and we look forward to delivering these much needed drug candidates to patients in need and ultimately creating shareholder value.”

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