BioVersys: First ever patient dosed with alpibectir-ethionamide in combination with first-line TB drugs in a 14-day phase 2 clinical trial

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. March 19, 2025, 7am CET.

• Under the BioVersys and GSK collaboration agreement, GSK is evaluating the early bactericidal activity (EBA) of alpibectir-ethionamide (AlpE) in a pulmonary tuberculosis (TB) trial, in combination with first-line TB drugs.
• Development of AlpE is strongly supported by European Union and European Pharmaceutical Industry through UNITE4TB, an Innovative Medicines Initiative (IMI2) Joint Undertaking.
• The EBA trial is expected to enroll 60 pulmonary TB patients and run untill end of 2025.
• Topline data readout by Q2 2026.

BioVersys AG (SIX: BIOV), a multi-asset, clinical stage biopharmaceutical company focusing on research and development of novel antibacterial products for serious life-threatening infections caused by multidrug-resistant (MDR) bacteria, announced today, that the first patient has been dosed in a pulmonary TB Phase 2 clinical trial, evaluating the early bactericidal activity (EBA) and safety of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs for the first time. The study is being conducted under the European Union’s IMI2 UNITE4TB project.

Through UNITE4TB, AlpE is being studied for the first time in a 14-day EBA clinical trial in combination with first-line TB drugs, marking a significant step forward in the further development of this unique combination. Through this Phase 2 TB drug combination trial, BioVersys and its partner GSK seek to get further insights of the potential impact of AlpE in TB patient’ treatments. Under the GSK-BioVersys collaboration agreement, GSK is responsible for developing AlpE for pulmonary indications and BioVersys is addressing TB meningitis (TBM), with BioVersys targeting the start of a TMB trial in H1-2026. This collaborative, two-pronged approach of BioVersys and GSK with their clinical trials partner TASK, aims to expedite the development of AlpE to TB patients.

Alpibectir (also known as BVL-GSK098) is a small molecule developed from BioVersys’ award winning Transcriptional Regulatory Inhibitory Compounds (TRIC) platform in a successful collaboration with GSK, the Institut Pasteur Lille and the University of Lille. The compound represents a novel concept to overcome resistance and significantly potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB. In 2023 the fixed-dose combination of AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA).

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “Alpibectir has shown a very promising safety profile and to be well tolerated, in both a Phase 1 and a 7-day EBA Phase 2a study, in which the AlpE combination delivered a first human proof of concept, with bactericidal activity similar to isoniazid in patients with tuberculosis. Based on these very promising data we are excited to study AlpE in a second Phase 2 EBA study, this time testing the efficacy, safety, tolerability and pharmacokinetics over a 14-day period and importantly in combination with first-line TB drugs.”

Prof. Andreas Diacon, Founder and Chief Scientific Officer at TASK and WP4 Lead in UNITE4TB: “Following the highly successful Phase 2a study, we are delighted to continue collaborating with GSK and BioVersys to advance AlpE. The drug combination demonstrated activity and tolerability comparable to isoniazid, a potent agent against tuberculosis. This extended study aims to optimize AlpE usage and to assess its potential as a replacement for isoniazid when administered in conjunction with established antibiotics.”

David Barros-Aguirre Head of Global Health Medicines R&D, GSK and UNITE4TB Project Lead: “Tuberculosis (TB) remains a public health threat, disproportionately affecting vulnerable communities in high-burden countries around the world. The start of the Phase 2a clinical trial with alpibectir-ethionamide (AlpE), in combination with first-line TB drugs, signals an important step forward to combat drug resistant TB. Through our longstanding partnership with BioVersys, and UNITE4TB, we are working to change the trajectory of the TB epidemic.”

Dr. Marc Gitzinger, Chief Executive Officer and founder of BioVersys: “Tuberculosis remains the largest infectious disease killer in the world and is far from being eradicated. Our partnership with GSK, to advance the development of alpibectir to reach patients in need, combined with the continued public sector support from the EU IHI UNITE4TB program, shows how public-private partnerships can work on delivering solutions for global health. We are excited to continue the development of alpibectir in pulmonary TB and in parallel, at BioVersys, we are also preparing for a first study in TB meningitis patients.”

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