Trial signals major milestone in hunt for new TB drugs

Updated on 24 July 2012

TB is one of the world's most ancient and deadly infectious diseases, dating back thousands of years and found in remains of Egyptian mummies. When HIV/AIDS exploded in the 1980s and 1990s, especially in sub-Saharan Africa, that epidemic triggered a historic jump in the number of TB deaths. An estimated 1.4 million people die from TB, and roughly 9 million people develop the disease, each year. One-third of all people on earth-nearly 2.5 billion people-have a latent form of TB.

The study, NC-001, or New Combination 1, was a two-week trial successfully completed at two centers in South Africa. It involved the new combination therapy called PaMZ, consisting of the novel TB drug candidate, PA-824; moxifloxacin, an established antibiotic not yet approved for use in first-line TB therapy and being developed in partnership with Bayer Healthcare AG; and pyrazinamide, an existing TB drug. NC-001 was funded by the Bill & Melinda Gates Foundation, the United States Agency for International Development, UK Aid, and Irish Aid.

"Treating drug-sensitive and drug-resistant TB with the same regimen can simplify the delivery of TB treatment worldwide," said Dr Andreas Diacon, the trial's principal investigator and lead author of the Lancet study. "The results of this study give healthcare providers on the front lines of the TB epidemic hope for better, faster tools needed to stop this disease."

A second trial called New Combination 2 (NC-002) was launched earlier this year to test the PaMZ combination over two months in patients, further advancing it through clinical development. NC-002 is currently enrolling patients and will be conducted at eight sites in South Africa, Tanzania and Brazil, and will build global capacity for TB trials.

In addition to these results, pharmaceutical companies are seeking regulatory approval for individual TB drug candidates-advances made possible by the existence of the most promising research pipeline for TB drugs in history. TB experts say any new drugs for tuberculosis would be an extraordinary development, but that new TB drug combinations are potential game-changers due to their expected impact.

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