BioVersys Doses First Patient in Phase 2b Trial of AlpE for Tuberculosis

BioVersys AG announced on March 12, 2026, 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 Q2 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 H1 2026.

The company has published promising clinical proof of concept results in the New England Journal of Medicine from a Phase 2a clinical trial of AlpE in patients with pulmonary TB. 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.

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. 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.

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).

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 consistently shows promise as a new therapeutic option in combination with ethionamide for addressing tuberculosis. It's considered to be generally well tolerated with a promising safety profile demonstrated across a number of Phase 1 and Phase 2 clinical trials, and has already demonstrated clinical proof of concept, with 7-day early bactericidal activity similar to isoniazid in patients with tuberculosis in a Phase 2a study.