The STAND trial tested the novel three-drug regimen PaMZ as a shorter, simpler and safer treatment for drug-sensitive and drug-resistant TB. PaMZ is a three-drug combination therapy, consisting of the new drug candidate, pretomanid (PA-824), an existing antibiotic not yet approved for TB, moxifloxacin, and the existing TB drug, pyrazinamide. Based on preclinical data, and the results of NC-001 and NC-002, the combination showed potential to shorten treatment time for drug-sensitive TB (DS-TB) and some multidrug-resistant TB (MDR-TB) patients.
The STAND trial was put on partial clinical hold in 2015. During that time, TB Alliance received results of another trial for the BPaMZ regimen, which appears to be more promising than the PaMZ regimen. The delay the enrollment hold caused has closed the gap in the time it will take for the BPaMZ and PaMZ regimens to come to market. Given the similar timelines and the superiority of results of the BPaMZ regimen, TB Alliance has taken the decision to focus on advancing the BPaMZ regimen. The STAND trial will not re-open enrollment. For more information and the latest updates, please visit Clinicaltrials.gov.
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. All the associated data will be collected and analyzed, and findings from the trial will be made available.