BioVersys AG announced that the first patient has been dosed in a pulmonary TB Phase 2b clinical trial, evaluating the efficacy, safety and pharmacokinetics of alpibectir-ethionamide (AlpE) in combination with first-line TB drugs (NCT05807399). In this new Phase 2b trial, a portion of the recruited adults with drug sensitive pulmonary tuberculosis (DS-TB) will be dosed for 2-months with RZE in combination with AlpE, followed by 18 weeks with RH alone, to assess efficacy, safety and pharmacokinetics of AlpE. The study is being conducted in six African countries under the European Union?s IMI2 UNITE4TB project, with the Institute of Infectious Diseases and Tropical Medicine, LMU University Hospital Munich as the trial sponsor.
Through this Phase 2b TB drug combination trial, BioVersys and its partner GSK are progressing the development of this unique combination and taking the next step in terms of dose finding and potential positioning of AlpE in future TB drug regimens. This trial is expected to read-out by the end of 2027. Preceding this Phase 2b trial, AlpE underwent a second Phase 2a trial in which AlpE was assessed over 14 days in an open-label trial in combination with first line TB drugs.
Top-line data is expected to be available Second Quarter 2026. AlpE was generally well tolerated in this trial, supporting the progression into Phase 2b. BioVersys also plans to initiate a Phase 2 trial in meningeal TB in First Half 2026.
Alpibectir (previously 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. AlpE?s development has been strongly supported by European Union and European Pharmaceutical Industry through Innovative Medicines Initiative (IMI2) Joint Undertaking, EDCTP and now UNITE4TB.
The compound represents a novel concept to overcome resistance and potentiate the activity of an existing antibiotic, ethionamide (Eto) or prothionamide (Pto), for the treatment of TB, as demonstrated in a previous 7-day early bactericidal activity Phase 2a clinical trial, recently published in the New England Journal of Medicine, which provided a first human proof-of-concept. 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 (FDA), and similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA). Alpibectir (previously 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. Alpibectir acts through a novel mode of action, potentiating the activity of the anti-TB drug ethionamide (Eto). Alpibectir is being studied for its potential to, lower the efficacious human dose of Eto, minimizing of dose-dependent side effects, and overcome Eto resistance.
The combination alpibectir/Eto (AlpE) is being developed for the treatment of pulmonary TB and TB meningitis. In 2023 AlpE was granted orphan-drug designation (ODD) for the treatment of tuberculosis, by the U.S. Food and Drug Administration (U.S. FDA) providing for certain incentives including seven years US market exclusivity. Similarly in 2025, AlpE was granted Orphan Designation from the European Medicines Agency (EMA), providing for certain incentives including 10-year EU market exclusivity.
