Buoyed by the support of the CPTR initiative and its partners, clinical TB drug regimen development efforts are already underway. The TB Alliance recently completed the NC001 (or New Combination 1) Phase II study – the first TB clinical trial to evaluate multiple unapproved new TB drug candidates in combination. Building on this momentum, the paradigm of regimen development is positioned to become the gold standard for the field at large.
NC001 tested the three-drug regimen, PA-824, moxifloxacin, and pyrazinamide (PaMZ), as well as additional two-drug combinations thought to be potential “building blocks” of future regimens. At the same time, the trial was designed to validate the co-development paradigm backed by CPTR, and confirm the preclinical mouse-model as predictive of efficacy of regimens in humans.
An 8-week study of the PaMZ regimen in both drug-sensitive and drug-resistant patients is now being planned and will set the stage for a pivotal Phase III trial.
The TB Alliance will be presenting selected data from this trial at the conference of the International Union Against Tuberculosis and Lung Disease in Lille, France, and alongside data from other TB drug sponsors at the CPTR Workshop in Arlington, Virginia. To learn more, click here to view the agenda.