NC-002

The New Combination 2 (NC-002) Phase 2 SSCC trial continued to develop the PaMZ TB treatment regimen, comprised of PA-824, moxifloxacin, and pyrazinamide. It was an 8-week trial, which recruits both DS-TB and MDR-TB patients.

Background:

Overview

The New Combination 2 (NC-002) trial continued to develop the PaMZ TB treatment regimen. The PaMZ regimen is comprised of new TB drug candidates PA-824 and moxifloxacin, along with the existing TB drug, pyrazinamide. The Phase 2, 8-week trial was the first of its kind, as it will enroll both drug-sensitive TB (DS-TB) and multidrug-resistant (MDR-TB) patients and treat them with the same regimen. If successful, NC-002 will pave the way for Phase 3 registration studies of the PaMZ regimen. NC-002 was launched in 2012 and completed in 2013. Results will be available in 2014.

About the New Treatment(s)

PaMZ is a three-drug combination therapy, consisting of the new drug candidate, 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, the combination showed potential to shorten treatment time for drug-sensitive TB (DS-TB) and some multidrug-resistant TB (MDR-TB) patients and harmonize the treatment of drug-senstive and MDR-TB treatment with a single four-month, three-drug regimen.

Current TB therapy interacts poorly with commonly-used antiretroviral therapies, creating challenges to the treatment of the millions of TB-HIV co-infected patients. This is a major flaw in the current standard TB treatment, as TB is the leading cause of death among those with HIV. In addition to poor health outcomes, the difficulties of treating TB and HIV together create extremely challenging situations for healthcare systems and treatment providers. PaMZ projects to be an ARV-friendly regimen.

In addition to those with HIV, another group who would greatly benefit from the advance of the PaMZ regimen is MDR-TB patients, who today must take multiple types of drugs, including injectables, daily for up to two years. PaMZ projects to be a shorter and more affordable MDR-TB therapy, while also eliminating the need for injectable therapy, thereby substantially simplifying the administration of treatment.

Additionally, PaMZ can be administered in a fixed dose for all patients, and will therefore be simpler for health systems to deliver and patients to use.

About the NC-002 trial

NC-002 built on the TB Alliance’s two-week NC-001 trial, initiated in 2010, which was the first study to test novel TB drugs in combination. In NC-001, PaMZ was found to kill more than 99 percent of patients’ TB bacteria within two weeks, adding to the growing evidence that it could be more effective than existing treatments. NC-002 treated patients for two months and takes place at 8 sites in South Africa and Tanzania. The trial was the first to enroll both drug-sensitive TB and MDR-TB patients and treat them with the same regimen.

Timeline

NC-002 was completed in 2013. 

Additional Resources

Phase 2 (Advanced)

Trial Components

Regimens