BioVersys Announces First Patient Dosed in Phase 2b Clinical Trial of AlpE in Pulmonary Tuberculosis

Ad hoc announcement pursuant to Art. 53 LR

Basel, Switzerland. March 12, 2026, 7am CET.

• Under the BioVersys and GSK collaboration agreement, AlpE clinical development advances with first patient dosed in Phase 2b trial within UNITE4TB, following completion of a Phase 2a in adults with drug-susceptible pulmonary TB (DS-TB) in combination with RZE.[1]
• In the new Phase 2b trial in adults with DS-TB, AlpE will be dosed for two months together with RZE, patients then continue only with RH[2] for 18 weeks.
• Phase 2b results are expected by the end of 2027.
• In addition, BioVersys plans to initiate a Phase 2 trial in TB meningitis in H1 2026.

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 multi-drug resistant (MDR) bacteria, announced today, 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.

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,[3] 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).

Dr. Glenn E. Dale, Chief Development Officer of BioVersys: “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. We are now excited to investigate AlpE in this longer clinical study, in combination with first-line TB drugs.”

Prof. Michael Hoelscher, Director, Institute of Infectious Diseases and Tropical Medicine and Principal Investigator of the STEP2C trial: “With the evaluation of alpibectir, UNITE4TB is testing its fifth novel drug candidate in its innovative Phase 2b regimen selection platform, where we evaluate how novel assets are best combined with other licensed or new drugs. This approach will help to derisk the chance of progressing the wrong combination into Phase 3. LMU Hospital is proud to be the sponsor of a trial for such a promising drug.“

David Barros-Aguirre Head of Global Health Medicines R&D, GSK and UNITE4TB Project Lead: “Tuberculosis (TB) remains a major public‑health threat, disproportionately affecting vulnerable communities in high‑burden countries. Advancing alpibectir‑ethionamide (AlpE) into a Phase 2b trial, in combination with first‑line TB drugs, represents an important step in addressing isoniazid resistance and evaluating the potential of this combination for the treatment of other forms of drug‑resistant TB. Through our longstanding partnership with BioVersys and UNITE4TB, we remain committed to changing the trajectory of the TB epidemic.”

Dr. Marc Gitzinger, Chief Executive Officer of BioVersys: “We are grateful to all our partners for their support of the clinical development of AlpE for TB patients. The unique clinical trial platform, UNITE4TB, provides the ideal opportunity to investigate AlpE’s potential benefit for TB patients. UNITE4TB is a landmark EU IHI program public and private partnership setting new standards in TB drug development and future regimen finding. We are excited to include AlpE in this program and investigate it alongside other novel assets with the potential to transform the future care for TB patients.”

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