BioVersys AG Reports Promising Phase 2a TB Results Published in The New England Journal of Medicine

In a significant development for global tuberculosis (TB) research, BioVersys AG has announced the publication of positive Phase 2a clinical data for AlpE in The New England Journal of Medicine. The results provide clinical proof of concept for a novel strategy aimed at overcoming drug resistance in pulmonary tuberculosis.

TB remains one of the world’s leading infectious disease killers, with drug-resistant strains posing a growing global health challenge. New therapeutic approaches are urgently needed to improve outcomes and combat resistance.

A Novel Approach: Boosting an Existing Antibiotic

AlpE is a combination of alpibectir and ethionamide (Eto). Alpibectir is a small molecule designed to enhance the activity of ethionamide, a well-established second-line TB drug. Rather than replacing existing antibiotics outright, alpibectir works through a novel mechanism to potentiate ethionamide’s activity and overcome resistance—effectively breathing new life into an existing therapy.

The molecule was discovered through a public-private collaboration involving GSK, the Pasteur Institute of Lille, and the University of Lille.

Inside the Phase 2a bEto-TB Trial

The Phase 2a bEto-TB study was conducted in South Africa by a consortium comprising TASK, GSK, and BioVersys, and was completed in April 2024.

The 7-day early bactericidal activity (EBA) study enrolled patients with pulmonary tuberculosis and demonstrated promising proof of concept for AlpE. The data showed:

• Favorable safety and tolerability
• Encouraging pharmacokinetic profile
• Promising early efficacy signals

Importantly, the combination enhanced ethionamide’s antibacterial activity at lower, well-tolerated doses.

Researchers are exploring AlpE as a potential replacement for isoniazid (INH) in the current first-line TB regimen, or as an additional bactericidal agent in future treatment combinations—including regimens targeting TB meningitis, where treatment options remain limited.

Strong Backing from Global Health Partnerships

The development of AlpE has been supported by major European public-private initiatives, including:

• The EU Innovative Medicines Initiative 2 (IMI2)
• The TRIC-TB and UNITE4TB projects
• The European & Developing Countries Clinical Trials Partnership (EDCTP2 programme)

Michelle Nderu of the EDCTP Association highlighted the importance of sustained global health investment, noting that the bEto-TB trial reflects both scientific innovation and the power of collaborative partnerships.

Looking Ahead: Expanding Clinical Development

Dr. Glenn Dale, Chief Development Officer of BioVersys, expressed encouragement over the Phase 2a results and confirmed that further Phase 2 studies are underway within the UNITE4TB program, led by GSK. In addition, BioVersys plans to initiate a Phase 2 trial in meningeal TB later this year.

Professor Andreas Diacon of TASK emphasized that the addition of alpibectir appears to make ethionamide more potent and better tolerated, potentially positioning AlpE as part of future combination regimens for both drug-sensitive and drug-resistant TB.

Dr. David Barros-Aguirre, Head of Global Health Medicines R&D at GSK, underscored the urgent need for innovation in TB care, particularly in lower-income countries where the disease burden is highest.

A Potential Shift in TB Treatment Strategy

The bEto-TB program introduces BVL-GSK098 (alpibectir) as a new anti-TB molecule capable of augmenting existing therapies rather than replacing them outright. By strengthening ethionamide’s effectiveness and potentially offering an alternative to isoniazid in first-line treatment, AlpE represents a novel and potentially transformative strategy in TB management.

With publication in one of the world’s most respected medical journals and continued advancement into Phase 2 studies, AlpE may mark an important step toward shorter, safer, and more effective TB treatment regimens—particularly in the fight against multidrug-resistant tuberculosis.

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