BioVersys, a clinical-stage biopharmaceutical company, has announced that the New England Journal of Medicine has published positive proof-of-concept results from its Phase 2a trial of AlpE in patients with pulmonary tuberculosis (TB).

 

TB remains one of the world’s deadliest infectious diseases, with rising drug resistance rendering many treatments less effective. 

 

Alpibectir (AlpE), a small molecule with a novel mode of action, offers a fresh strategy: it enhances the activity of the existing antibiotic ethionamide (Eto), potentially overcoming resistance. The compound was developed through a successful public-private collaboration with GSK, the Pasteur Institute of Lille, and the University of Lille.

 

The Phase 2a bEto-TB trial, conducted in South Africa by a consortium of TASK, GSK, and BioVersys, concluded in April 2024. In a seven-day early bactericidal activity study in pulmonary TB patients, AlpE delivered encouraging clinical proof of concept. The therapy aims to replace isoniazid in current first-line regimens or serve as a new bactericidal option in future TB treatments, including TB meningitis.

 

The clinical program has benefited from extensive European Union support, including the IMI2 TRIC-TB and UNITE4TB projects, as well as funding from the EDCTP2 bEto-TB project.

 

Dr Glenn Dale, Chief Development Officer of BioVersys, said: “We are very pleased to see the favorable safety, tolerability and pharmacokinetics profile of AlpE, and even more so for the promising signals of efficacy delivered from this Phase 2a clinical trial. 

 

"These data give us real encouragement for the further Phase 2 studies in UNITE4TB, run by our partner GSK, where AlpE is being studied in combination with first line TB drugs. We are also excited as we plan to initiate a Phase 2 trial in meningeal TB later this year.”

 

Michelle Nderu, Project Officer at EDCTP Association, added: “The bEto-TB trial demonstrates the power of sustained investment in global health research. The development of AlpE reflects not only scientific innovation but also the strength of collaborative partnerships. With support from EDCTP2, these results bring us a step closer to delivering shorter, safer and more effective treatment options for people living with TB.”

 

Prof Andreas Diacon, Founder and Chief Scientist at TASK, noted: “At TASK we are grateful to our study participants whose collaboration allows yet another novel antibiotic to move a step forward. This study has shown that ethionamide, an established, low-cost and safe antibiotic, becomes more potent and better tolerated by the addition of alpibectir. 

 

"The AlpE combination is now on its way to become part of drug combinations that treat tuberculosis patients with and without resistance to other drugs, and it appears particularly suitable for patients with tuberculosis meningitis where better treatments are direly needed.”

 

Dr David Barros-Aguirre, Head of Global Health Medicines R&D at GSK, said: “TB remains one of the world’s deadliest infectious diseases, and tackling drug resistance is one of the biggest challenges we face. That’s why innovation is essential. 

 

"The Phase 2a results for AlpE mark an exciting step forward, demonstrating the potential of novel approaches to strengthen existing therapies. We are proud to collaborate with BioVersys, TASK and partners, to advance research aimed at transforming TB care for patients globally, particularly in lower-income countries where the disease remains most prevalent.”