BioVersys receives EMA Orphan Designation for the combination of alpibectir and ethionamide for the treatment of tuberculosis

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland, August 27, 2025, 7am CET

• Orphan designation is granted to drug candidates addressing life-threatening or chronically debilitating diseases affecting fewer than 5 in 10’000 EU residents
• EMA orphan status provides key incentives, including reduced fees, research and clinical protocol support, and 10-year EU market exclusivity

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 European Medicines Agency Committee for Orphan Medicinal Products (EMA COMP) has granted orphan designation for the combination of alpibectir and ethionamide (AlpE) for the treatment of tuberculosis (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 significantly potentiating the activity of an existing antibiotic, ethionamide (Eto). It is being developed for pulmonary and meningeal TB.

EMA’s orphan designation follows a successful clinical Phase 2a proof of concept trial and FDA’s Orphan Drug Designation (ODD) granted in 2023. The orphan designation reflects the potential for AlpE to improve treatment options for patients who have TB and to overcome resistance to TB medicines. Alpibectir was identified in a successful public-private collaboration with GSK, the Pasteur Institute of Lille and the University of Lille. Currently, alpibectir is being studied in a Phase 2 trial in pulmonary TB in combination with first line TB drugs. This trial is being run within the European Union’s IMI2 UNITE4TB project with our partner GSK. In parallel, dosing in a Phase 2 trial for meningeal TB is anticipated to start in early 2026.

Dr. Glenn Dale, Chief Development Officer of BioVersys: “The EMA orphan designation validates our mission to deliver urgently needed therapies for TB patients, who face prolonged treatment durations and unacceptably high mortality rates. We are pleased that this effort continues to be supported by a public-private partnership.”

Dr. David Barros-Aguirre, VP and Head of Global Health Medicines R&D, GSK: “We are pleased with the progress being made with our partner BioVersys on the development of alpibectir for tuberculosis. The EMA orphan drug designation is an important step towards addressing drug resistance in TB treatment. This collaboration highlights GSK’s commitment to working with partners to bring essential medicines and vaccines to those who need them.”

Clinical development of AlpE has been supported by several European grants, including the EU IMI2 TRIC-TB Project, the EU IMI2 UNITE4TB project and the European & Developing Countries Clinical Trials Partnership (EDCTP2 program).

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