EMA Grants Orphan Designation to BioVersys for Tuberculosis Treatment

BioVersys AG, a clinical stage biopharmaceutical company, has been granted orphan designation by the European Medicines Agency for a new combination treatment targeting tuberculosis. The combination of alpibectir and ethionamide (AlpE) aims to tackle drug-resistant tuberculosis, a significant global health issue. This status offers incentives like reduced fees and 10-year EU market exclusivity, supporting the development of this promising treatment.

Alpibectir, developed in collaboration with GSK, the Pasteur Institute of Lille, and the University of Lille, enhances the efficacy of ethionamide, a current TB antibiotic. Following a successful Phase 2a trial and recognition by the FDA, ongoing trials within the EU focus on both pulmonary and meningeal forms of the disease. The initiative is part of broader efforts to address multi-drug resistant TB.