Sparks - BioVersys

BioVersys has announced that it has filed the first clinical trial application for lead asset BV100, marking a major step towards initiation of the Phase III programme in ventilator-associated bacterial pneumonia (VABP). The Phase III design (n=250) will follow a similar design to the Phase II study, which demonstrated a 50% reduction in mortality in VABP patients with carbapenem resistant Acinetobacter baumannii (CRAB) compared with best available therapy. First patient dosing is expected in Q126, with topline readouts in H227. The Phase III programme will be self-funded using internal resources, with CHF92.1m in cash at end-June 2025 providing a runway into 2028.

In addition, BioVersys also plans to conduct an investigator-initiated Phase IIb study (n=90) comparing BV100 to best available therapy (including Xacduro) instead of standard-of-care colistin to be used in the Phase III programme. This study is expected to commence in H126 and will be conducted by the ADVANCE-ID clinical trial network, supported by S$22m (CHF14m) funding from the Wellcome Trust.