BioVersys' BV100 advances into phase II clinical trials

In Europe, around 4 million hospital-acquired infections (HAIs) occur annually, and antibiotic resistance is responsible for an estimated 33,000 deaths/year, with EUR 1.5 billion in healthcare costs and productivity losses per annum. Worldwide more than 700’000 lives are estimated to be lost annually, and this is predicted to rise to 10 million by 2050. There are little to no effective and safe treatment options.

With its lead product BV100, BioVersys has developed a potential breakthrough hospital antibiotic to treat serious infections caused by Carbapenem-Resistant Acinetobacter baumannii (CRAB) in indications of ventilator-associated bacterial pneumonia (VABP), hospital-acquired bacterial pneumonia (HABP) and bloodstream infections (BSI).

Additionally, the discovery of a novel mode of action of BV100 on the active uptake of rifabutin into the Gram-negative bacterial species, Acinetobacter baumannii, allows the company to target RNA-polymerase in Gram-negative bacteria for the first time with a human-relevant dose. This results in strong bactericidal activity.

Bioversys has now completed three Phase I clinical trials: Single-ascending dose (SAD) study, Multiple-ascending dose (MAD) study and Renal impairment (RI) study. The analysis of preliminary, blinded data from these studies showed a favourable safety, tolerability and pharmacokinetic profile of BV100 at doses within the therapeutic range in healthy volunteers and people with varying degrees of renal impairment.

Glenn E. Dale, Chief Development Officer of BioVersys: “We are pleased by the favourable safety of BV100 at the doses studied in our clinical trials. This positive data paves the way for a Phase II clinical trial that will be conducted in patients with nosocomial pneumonia caused by Acinetobacter baumannii including CRAB. The combination of the injectable formulation and the novel mode of action will position BV100 as a potential breakthrough therapy in CRAB-infected patients.”

“Our clinical development program for BV100 is on track, and we also have the right team in place to execute the next phase of the program. BV100 is protected by three patent applications globally, recently receiving an allowance in the US. BV100 remains an important clinical asset in our diverse and value-adding pipeline and has the potential to become a critical life-saving therapy for patients afflicted with resistant CRAB infections,” said Marc Gitzinger, Chief Executive Officer and founder of BioVersys.

(Press release/RAN)