PaMZ was the first novel multi-drug TB treatment to undergo clinical testing in the new regimen development paradigm. PaMZ was tested in the Phase 2a NC-001 trial, in which it killed TB bacteria faster when compared with the current TB regimen, as well as other experimental regimens over the first two weeks of treatment. It was subsequently tested in NC-002, in which it met its primary endpoint after eight weeks treatment. PaMZ has the potential to cure both TB and some forms of MDR-TB, simplifying and improving treatment. This regimen projects to be able to be effectively administered alongside common ARV treatments, thereby improving treatment options for patients co-infected with TB and HIV. It also shows promise for MDR-TB patients who are sensitive to the drugs in the regimen, reducing treatment time and costing just a fraction of the current MDR-TB treatment. Additionally, the PaMZ regimen can be administered in a fixed dose for all patients, and will therefore be simpler for health systems to deliver and patients to use.
In 2015, the STAND trial was put on partial clinical hold. In 2016, more promising results became available. Given the superior results and the delay the enrollment hold caused, which has closed the gap in the time it will take for the regimens to come to market, TB Alliance has taken the decision to focus on advancing the BPaMZ regimen. Although the STAND trial will not re-open enrollment, we will continue to follow all patients as per the protocol. Of the 284 patients enrolled in the STAND trial, all have now completed treatment and six months of follow up. TB Alliance will continue to follow all the patients in the trial for two years as per the original study design.