BioVersys doses first subjects in Phase 1 clinical trial of BV100

BioVersys is a privately owned, multi-asset Swiss pharmaceutical company focused on developing small molecules for multidrug-resistant bacterial infections with applications in Anti-Microbial Resistance (AMR) and targeted microbiome modulation. 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/year. Worldwide more than 700’000 lives are estimated to be lost annually, and this is predicted to rise to 10 million by 2050.

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). There are little to no effective and safe treatment options for this field today. 

Phase 1 clinical trials kick-off
BioVersys has marked a new milestone, following the launch of Phase 1 clinical trials of BV100 and dosing the first healthy volunteers. The study aims to evaluate the safety, tolerability, and pharmacokinetics of BV100 in healthy human volunteers through Single Ascending Dose (SAD), and Multiple Ascending Dose (MAD) studies.

Positive results from pre-clinical studies
BV100 has completed GLP toxicology studies and has shown outstanding in vitro and in vivo efficacy in several animal models, with unprecedented in vitro strain coverage against CRAB and a very low propensity to develop resistance. It was granted QIDP Designation by the U.S. FDA in May 2019 for use in the treatment of VABP, HABP and BSI, making BV100 eligible for priority FDA review, Fast Track designation, and a five-year extension of market exclusivity upon approval of the first QIDP indication.

Glenn E. Dale, Chief Development Officer of BioVersys: “Based on its extensive pre-clinical data package, BV100 is expected to offer a new therapeutic option for clinicians treating patients suffering from highly resistant Acinetobacter baumannii infections. CRAB infections are associated with extremely high mortality rates of ≥ 50% due to limited therapeutic choices and BV100 can offer a novel therapeutic option for use by clinicians.”

Advanced pipeline
Alongside BV100, Bioversys is developing, BVL-GSK098 in collaboration with GSK for the treatment of multi-drug resistant tuberculosis infections. The drug candidate has received a Qualified Infectious Disease Product designation from the U.S. for oral use in the treatment of pulmonary tuberculosis in June 2020. This milestone paves the way for the first in human trials.

(Press release/RAN)