ZeNix is a clinical trial to testing a novel regimen that holds the potential to be a shorter, all-oral, and affordable treatment for XDR-TB. ZeNix is testing a regimen consisting of three drugs with minimal resistance, pretomanid, bedaquiline, and linezolid (BPaL). It will evaluate whether the efficacy of the BPaL drug regimen can be maintained, while reducing toxicity by testing a lower dose and shorter duration of the drug linezolid.
People suffering from XDR-TB have very few treatment options – cure rates are extremely low and mortality rates are extremely high. ZeNix is a successor to Nix-TB, the world’s first clinical trial to study an XDR-TB drug regimen with only pills – no injections – and minimal pre-existing resistance. The trial tests a three-drug regimen consisting of bedaquiline, pretomanid and linezolid and enrolls participants at XDR-TB at sites in Africa and Eastern Europe, broadening the potential patient population of Nix-TB and evaluating whether the efficacy of the BPaL drug regimen can be maintained, while reducing linezolid toxicity by testing a lower dose and shorter duration of the drug.
About the New Treatment(s)
The Nix-TB regimen consists of bedaquiline, which received conditional regulatory approval in several high-TB disease burden countries; the novel antibacterial drug compound pretomanid, which is being tested in multiple clinical trials for TB; and linezolid, an oxazolidinone that has been used off-label to treat TB.
ZeNix began in Q4 2017. ZeNix is scheduled to report findings on an ongoing basis at predetermined milestones.
- Safety and Efficacy of Various Doses and Treatment Durations of Linezolid Plus Bedaquiline and Pretomanid in Participants With Pulmonary TB, XDR-TB, Pre- XDR-TB or Non-responsive/Intolerant MDR-TB (ZeNix) (clinicaltrials.gov link)