Putting Patients First
TB Alliance’s ZeNix trial of the BPaL regimen (bedaquiline, pretomanid, and linezolid) in South Africa, Eastern Europe, and Russia sought to optimize a six-month, all-oral treatment regimen by assessing various dosing modifications of the linezolid component of BPaL. Presented at the 11th IAS Conference on HIV Science, the data demonstrate improvement in the safety and tolerability of the BPaL regimen with alterations in linezolid dosing. “The results of this study are very reassuring. With a reduction in the dose and/or duration of linezolid, we can still offer patients a high chance of cure in only six months,” said Dr. Francesca Conradie, principal investigator for the ZeNix clinical trial, as well as South Africa’s Clinical Access Program for the regimen.
Reaching Those in Need
To date, 15 countries or regulatory bodies have approved pretomanid as part of the BPaL regimen for the treatment of patients with highly drug-resistant forms of TB, and regulatory applications have been submitted to another 17 countries and counting by Viatris, one of TB Alliance’s commercialization partners. A further 11 countries are actively enrolling patients in operational research to continue gathering evidence and implementing the regimen in other regions. The evidence generated from the Nix-TB and ZeNix clinical trials, which is now being replicated through operational research programs such as LIFT-TB, underscores the potential of short, all-oral, BPaL-based regimens for patients with highly drug-resistant TB.
Advancing TB Science
TB Alliance advanced the development of new TB medicines while navigating the spread of COVID-19 by pivoting research projects from labs within and across borders. As a global product development partnership with relationships all around the world, TB Alliance worked closely with our partners and researchers to advance both early- and late-stage research.
- Adding new projects in the Lead Optimization phase
- Advancing TBAJ-587 to Phase 1
- Completing the process chemistry effort for TBI-223
- Publishing preclinical results on TBAJ-876 showing shorter and more effective treatment over bedaquiline
- Finalizing and presenting results from the ZeNix Phase 3 trial
Recognizing Healthcare Heroes
In another year of unprecedented challenges, TB Alliance and its partners could not have advanced the TB drug research agenda without the healthcare and essential workers around the world who have worked tirelessly day after day to fight the COVID-19 pandemic and continue to help those impacted by health threats like TB. We are indebted to their work.
Making a Difference
Dr. Nosipho Ngubane is a clinical investigator in South Africa studying new treatments for patients with TB and HIV, including BPaL-based regimens. She is committed to helping develop shorter, more effective TB therapies because they “could make a very big difference” in the community and make it “easier for people to comply and take their treatment until the end.” TB Alliance relies on the dedication and insight of partners all around the world, like Dr. Ngubane, to help realize breakthroughs in TB care that can help overcome humanity’s longest pandemic.