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PaMZ

Pretomanid + Moxifloxacin + Pyrazinamide

Background:

“PaMZ” was the first novel multi-drug TB treatment to undergo clinical testing in the new regimen development paradigm. It consisted of pretomanid (Pa), moxifloxacin (M), and pyrazinamide (Z). PaMZ was tested in the Phase 2a NC-001 trial, in which it killed TB bacteria faster when compared with the current TB regimen (HRZE), 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. In 2015, PaMZ progressed to a Phase 3 trial, known as STAND.

The STAND trial was subsequently 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 additonal monitoring for two years, as per the original study design.

 

 

 

    Regimen Trials