bEto-TB achieves key milestones in advancing drug-resistant tuberculosis treatment
At the end of August 2025, BioVersys AG announced that the European Medicines Agency’s Committee for Orphan Medicinal Products (EMA COMP) had granted orphan designation for the combination of alpibectir and ethionamide (AlpE) for the treatment of tuberculosis (TB). This milestone reflects years of collaborative work under the bEto-TB consortium, funded by the EDCTP2 programme and led by the TASK Foundation, South Africa, with support from GSK and BioVersys SAS.
“I am proud to see bEto-TB reach such an important milestone. The EMA’s orphan designation for AlpE is not only a recognition of scientific innovation but also of the strength of collaborative partnerships. With EDCTP2 support, the consortium has combined expertise and innovation to advance safer, more effective treatment options for people with drug-resistant TB. Building on this progress, we look forward to future studies that could transform TB therapy worldwide.”
Ms Michelle Nderu, Project Officer, EDCTP Association
Tackling drug-resistant TB
Tuberculosis remains one of the leading infectious killers worldwide, with drug resistance threatening decades of progress. Ethionamide is a long-established TB drug whose clinical potential has been limited by dose-related side effects. The bEto-TB consortium was formed to address this challenge by combining ethionamide with alpibectir, a novel small molecule discovered by GSK in collaboration with BioVersys. Alpibectir enhances ethionamide’s bacterial bioactivation, allowing for much lower ethionamide doses without loss of efficacy.
Clinical progress through collaboration
Within the phase IIa TASK-010 bEto-TB trial (NCT05473195), the consortium has evaluated the early bactericidal activity, safety and pharmacokinetics of six different treatment arms. Interim findings show that combining alpibectir with reduced doses of ethionamide can maintain or even improve antibacterial activity while minimising intolerability — addressing one of the key barriers to wider use of ethionamide in resistant TB.
A platform for future regimens
The EMA orphan designation for AlpE follows a successful phase IIa proof-of-concept study and builds on the U.S. FDA’s Orphan Drug Designation granted in 2023. This recognition underscores the potential of AlpE to replace isoniazid in first-line regimens and serve as a strong candidate for inclusion in second-line TB treatment. By revitalising an existing antibiotic and pairing it with an innovative potentiator, the bEto-TB project exemplifies how public–private partnerships can be leveraged to accelerate unique solutions for neglected but critical global health needs. Further clinical studies planned under the IMI2 UNITE4TB project will build on these results to define optimal dosing and move AlpE toward late-stage trials.