BioVersys Receives EMA Orphan Designation for the Combination of Alpibectir and Ethionamide for the Treatment of TB

27 August 2025

August 27, 2025 — BioVersys AG announced 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 TB.

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 in partnership with GSK. In parallel, dosing in a Phase 2 trial for meningeal TB is anticipated to start in early 2026.

Read the full company press release here.

Source: BioVersys AG