BioVersys and partners’ phase 2a tuberculosis trial results published in New England Journal of Medicine

Basel, Switzerland, February 19, 2026, 7am CET

• Data from Phase 2a study demonstrated the first clinical proof of concept for alpibectir in combination with ethionamide (AlpE) in the treatment of patients with tuberculosis.
• The results, published in the prestigious New England Journal of Medicine, underscore the significant potential of AlpE to shape the future of TB treatment.

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 the publication of promising clinical proof of concept results in the prestigious New England Journal of Medicine from the Phase 2a clinical trial of AlpE in patients with pulmonary TB.

Tuberculosis is one of the leading causes of death by infectious diseases globally, and many existing treatments are becoming less effective due to growing drug resistance. Alpibectir, a small molecule acting through a novel mode of action, represents a totally new concept of overcoming resistance by potentiating the activity of an existing antibiotic, ethionamide (Eto), and was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille.

The Phase 2a bEto-TB clinical trial was conducted in South Africa through a consortium of three partners, TASK, GSK and BioVersys, and was completed in April 2024. AlpE delivered a promising clinical proof of concept in a 7-day early bactericidal activity (EBA) study, conducted in patients with pulmonary tuberculosis. AlpE seeks to offer a replacement for isoniazid (INH) in the current first-line regimen or to be added as a novel bactericidal drug to future regimens including those of TB meningitis.

The clinical development of AlpE has been strongly supported by several European Union grants and public private partnerships, including the EU Innovative Medicines Initiative 2 (IMI2), TRIC-TB project and UNITE4TB project, and the European & Developing Countries Clinical Trials Partnership (EDCTP2 programme), bEto-TB project.

Dr. Glenn Dale, Chief Development Officer of BioVersys: “We are very pleased to see the favorable safety, tolerability and pharmacokinetics profile of AlpE, and even more so for the promising signals of efficacy delivered from this Phase 2a clinical trial. These data give us real encouragement for the further Phase 2 studies in UNITE4TB, run by our partner GSK, where AlpE is being studied in combination with first line TB drugs. We are also excited as we plan to initiate a Phase 2 trial in meningeal TB later this year.”

Michelle Nderu, Project Officer, EDCTP Association: “The bEto-TB trial demonstrates the power of sustained investment in global health research. The development of AlpE reflects not only scientific innovation but also the strength of collaborative partnerships. With support from EDCTP2, these results bring us a step closer to delivering shorter, safer and more effective treatment options for people living with TB.”

Prof. Andreas Diacon, Founder and Chief Scientist at TASK: “At TASK we are grateful to our study participants whose collaboration allows yet another novel antibiotic to move a step forward. This study has shown that ethionamide, an established, low-cost and safe antibiotic, becomes more potent and better tolerated by the addition of alpibectir. The AlpE combination is now on its way to become part of drug combinations that treat tuberculosis patients with and without resistance to other drugs, and it appears particularly suitable for patients with tuberculosis meningitis where better treatments are direly needed.”

Dr. David Barros-Aguirre, Head of Global Health Medicines R&D, GSK: “TB remains one of the world’s deadliest infectious diseases, and tackling drug resistance is one of the biggest challenges we face. That’s why innovation is essential. The Phase 2a results for AlpE mark an exciting step forward, demonstrating the potential of novel approaches to strengthen existing therapies. We are proud to collaborate with BioVersys, TASK and partners, to advance research aimed at transforming TB care for patients globally, particularly in lower-income countries where the disease remains most prevalent.”

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