BioVersys secures CHF 14 million for new clinical study on hospital infections

11.11.2025

Basel-based BioVersys will advance its lead anti-infective candidate BV100 into Phase 2b clinical development with support from Wellcome. The study will be conducted through the ADVANCE-ID clinical trial network, with the first patient expected to be dosed in the first half of 2026.

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BV100 is a novel intravenous formulation of rifabutin developed to treat hospital-acquired infections caused by Acinetobacter baumannii, including carbapenem-resistant strains (CRAB). The compound features a newly identified mechanism of action that enables the active uptake of rifabutin into Gram-negative bacteria, allowing the targeting of the RNA-polymerase enzyme with a human-suitable dose—an unprecedented approach for this bacterial group.

The Phase 2b study will be conducted within the ADVANCE-ID (ADVANcing Clinical Evidence in Infectious Diseases) network, coordinated by the Saw Swee Hock School of Public Health at the National University of Singapore. Wellcome has allocated SGD 22 million (approximately CHF 14 million) to strengthen the network and enable this first sponsor-driven trial in collaboration with BioVersys—that has ranked for several years among the Top100 Swiss Startups, won Venture Kick, joined two Venture Leaders programs, and participated in the first SIX IPO Academy in 2022 to prepare and equip Top100 scaleups for a potential listing on the Swiss Stock Exchange.

"Through Venture Kick,
we connected with our
now long-term partner GSK."

Taking place across several Southeast Asian countries where drug-resistant infections are highly prevalent, the study will expand from two to three treatment arms. It will evaluate BV100 in combination with either Ceftazidime/avibactam or Cefiderocol, alongside a Best Available Therapy arm. This expanded design increases the number of evaluable patients in Part A from 60 to 90, while Part B will include 10 additional patients suffering from CRAB-related ventriculitis and meningitis.

The open-label, randomized trial is expected to start dosing in early 2026, with interim data anticipated in the second half of the year. Findings from this study will support the upcoming BV100 Phase 3 program and future regulatory submissions in the US, Europe, and China.

Established in 2022 with Wellcome’s initial support, the ADVANCE-ID network has already conducted research involving over 10,000 patients affected by severe bacterial infections. The new study will further expand its capacity and contribute to global efforts addressing antibiotic resistance.

CSO Sergio Lociuro, CEO Marc Gitzinger, and Chief Development Officer Glenn Dale

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