Today, the TB Alliance announced the first clinical trial to test multiple new TB drugs in combination; the trial is known as New Combination 1 (NC001).The experimental regimen undergoing testing in this trial consists of experimental TB drugs PA-824, Moxifloxacin, and Pyrazinamide, an antibiotic commonly administered as part of current TB treatment. This regimen has shown potential to harmonize treatment for TB drug-sensitive tuberculosis (DS-TB) and multidrug-resistant tuberculosis (MDR-TB) under a single three-drug regimen.
(this video shows an NC001 clinical trial participant, Wally J, talking about his experience with TB and why he’s involved in the trial)
NC001 is being tested under a research platform championed by the Critical Path to TB Drug Regimens (CPTR) initiative that has the potential to shorten the time needed to develop novel TB regimens by as much as 75% by testing multiple previously unregistered TB drugs simultaneously, in combination.
NC001 holds promise, in particular, for drastically improving MDR-TB treatment. Based on preclinical data, NC001 offers potential to reduce the treatment duration of MDR-TB from up to 2 years to less than 6 months. Current MDR-TB treatment is extremely costly, which drastically limits the scaling up of MDR-TB treatment around the world; today only 1% of estimated MDR-TB patients receive proper treatment. NC001 also projects to be less expensive than current therapies, in addition to being less resource-intensive to administer. For these reasons, if successful, NC001 could help enable the global scale-up of MDR-TB treatment that has been called for by the WHO, and recently in the New England Journal of Medicine.
In addition to the three-drug combination, NC001 also tests the combinations of PA-824 and Pyrazinamide, and TMC207 and Pyrazinamide. NC001 is a fourteen-day early bactericidal activity trial scheduled to enroll 68 patients, and follow them for three months after treatment.
According to Mel Spigelman, M.D., President and Chief Executive Officer, TB Alliance, “We need more than a new drug to eradicate TB—we need entirely new regimens of TB drugs. The potential to offer a single regimen to treat both drug-sensitive and multi drug-resistant TB represents a monumental advance in the treatment of patients worldwide, and a tremendous step toward simplifying the delivery of TB treatment globally.” Dr. Spigelman is also co-chair to the WGND.
Traditionally, researchers tested one new drug at a time in a series of lengthy and expensive clinical trials, meaning it would take decades to develop a completely novel drug combination. NC001 marks the beginning of a new era in TB drug development where new regimens will be tested simultaneously in combinations at an earlier stage of drug development.
With increased investments in TB R&D, there are promising TB compounds in the pipeline and the potential for shorter, simpler, safer, and more affordable treatment options capable of reducing the TB burden globally. This new treatment regimen testing signifies that effective TB treatment and control is more of a reality than ever before.
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