New combo TB regimen proves potent and effective in Phase-II trials

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Combination testing paradigm would reduce novel regimen testing time from decades to years

Early clinical trial results are promising for a new combination tuberculosis (TB) drug therapy that is proving potent and could reduce treatment time to just four months for patients with drug-sensitive TB as well as many drug-resistant strains, according to researchers from the Global Alliance for TB Drug Development (TB Alliance).

Funded by the Bill & Melinda Gates Foundation, the United States Agency for International Development, UK aid, and Irish Aid, the NC-001 Phase II clinical trial regimen killed more than 99 percent of participants’ TB bacteria within two weeks and could be more effective than existing treatment regimens. The study authors anticipate that the new combo regimen could treat both drug-susceptible and some drug-resistant TB strains in four months – reducing daily treatment time by two months for drug-susceptible TB and 14-20 months for some multi-drug resistant TB (MDR-TB) strains. The results were published in the Lancet Monday.

“Treating drug-sensitive and drug-resistant TB with the same regimen can simplify the delivery of TB treatment worldwide,” said Andreas Diacon, MD, 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.”

The results were simultaneously presented at the International AIDS Conference in Washington.  TB is the biggest killer of people living with HIV, and is responsible for approximately 50 percent of AIDS deaths in sub-Saharan Africa. Drug-drug interactions and side effects often complicate treating HIV/AIDS and TB simultaneously. The new regimen was found to have low interaction with antiretroviral therapy, offering the potential to treat people with HIV/TB co-infection.

Conducted at two centers in South Africa, the NC-001 trial treatment regimen – known as PaMZ – included a novel TB drug candidate (PA-824), an established antibiotic not yet approved for use in first-line TB therapy (moxifloxacin), and the existing TB drug pyrazinamide. This was the first-ever trial to test new tuberculosis drugs in a new combination paradigm – an approach that will reduce development time for novel TB therapies from decades to years.

“These findings confirm the promise of novel TB regimens to be shorter, simpler, safer, and, compared with today’s multidrug-resistant TB (MDR-TB) drugs, much less expensive,” said Mel Spigelman, MD, CEO and president of the TB Alliance. A press release from the organization highlighted that the regimen would eliminate the use of injectables to treat TB and would reduce the cost of MDR-TB therapy by as much as 90 percent. “The next trial to advance this regimen [NC-002] is already underway. We now have real momentum toward bringing to market treatments that will ultimately help save millions of lives,” Spigelman said.

NC-002 will test the PaMZ combination over two months in patients at eight sites in South Africa, Tanzania and Brazil and is currently enrolling patients.

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