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news.The Global Alliance for TB Drug Development (TB Alliance) has launched the first clinical trial to test a novel tuberculosis regimen in a new development paradigm designed to speed new treatments to patients.
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According to TB Alliance, the novel three-drug combination shows promise to treat both drug-sensitive (DS-TB) and multidrug-resistant TB (MDR-TB), and alter the course of the TB pandemic by shortening and simplifying treatment worldwide.
The Phase II trial, called NC001 or New Combination 1, tests the new TB drug candidates PA-824 and moxifloxacin in combination with pyrazinamide, an existing antibiotic commonly used in TB treatment.
Based on pre-clinical data, the combination shows potential to shorten treatment time for virtually all tuberculosis patients and harmonise the treatment of DS-TB and MDR-TB treatment with a single three-drug regimen.
If successful, the experimental regimen will offer a shorter, simpler, safer, and more affordable treatment option for MDR-TB, an emerging global health threat.
The trial involves 68 participants at two centers in South Africa, each receiving two weeks of treatment and three months of follow-up to evaluate effectiveness, safety, and tolerability.
TB Alliance CEO Mel Spigelman said that 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.