Nix-TB

Partners: Mylan

Nix-TB is a pivotal TB trial that tests the three-drug BPaL regimen, consisting of bedaquiline, pretomanid and linezolid – collectively referred to as the BPaL regimen. The trial enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. Nix-TB data have demonstrated a successful outcome in 95 of the first 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up.

Background:

Overview

Nix-TB is a pivotal trial that tests an all-oral XDR-TB drug regimen, known as BPaL, consisting of bedaquiline, pretomanid, and linezolid. Nix-TB enrolled participants at XDR-TB at sites in South Africa. It included patients as young as 14 and those who are co-infected with HIV with a CD4 count of 50 or higher. Nix-TB is an open-label trial that enabled participants to be assessed at regular intervals with the aim of being cured in six to nine months. After completing treatment, participants are monitored for two years to ensure they do not relapse. Nix-TB is a partnership between TB Alliance, the sponsor of the trial; Janssen Pharmaceuticals, the discoverer of bedaquiline; and the sites where the study is being conducted.

About the New Treatment(s)

BPaL 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. More information about pretomanid and BPaL can be found here.

Timeline

Nix-TB has completed enrollment. On August 14, 2019, the US FDA approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs.

Additional Resources

 

Phase 3

Trial Components

Regimens