The STAND trial tested the novel three-drug regimen PaMZ in both DS-TB and MDR-TB patients.
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 testing the BPaMZ regimen, which appeared to be more promising than the PaMZ regimen. The delay the enrollment hold caused closed the gap in projected timelines 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 decided to focus on advancing the BPaMZ regimen and did not resume enrollment in the STAND trial.
All patients enrolled in STAND were follwed as per the protocol even after new enrollment ceased. The 284 patients enrolled in the STAND completed treatment and six months of follow up, as well as additional monitoring for two years, as per the original study design.