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TB Alliance Launches Phase 2B Clinical Trial of a Novel TB Drug Regimen that Could Cut Treatment Time by Half or More for a Majority of TB Patients

NC-005 trial tests a novel regimen of bedaquiline (Sirturo), pretomanid (formerly known as PA-824), and pyrazinamide; results could pave the way for a three-month TB treatment

October 21, 2014

TB Alliance has launched a Phase 2B trial that will test the safety and effectiveness of a novel regimen with the potential to treat drug-sensitive tuberculosis and some forms of drug-resistant TB in as little as three months. The regimen, also known as BPaZ, contains two new drugs—bedaquiline (B, also known as Sirturo®) and pretomanid (Pa, and formerly known as PA-824)—and pyrazinamide (Z), an older, more established antibiotic.

“Preclinical data suggests that the BPaZ regimen has the potential to shorten the duration of TB treatment to as little as 3 months,” says Mel Spigelman, MD, President and CEO of TB Alliance. “This trial is a crucial component of a development program to provide critically needed improved TB therapy to meet the needs of patients and health care systems.”

Tuberculosis is a global pandemic, killing 1.3 million people in 2012—one person every 25 seconds. Today’s TB treatment is inadequate, and must be administered for 6 months to two years or more. Treatment for drug-resistant TB, such as multi-drug resistant TB (MDR-TB), is so complex, expensive, and toxic that only 20% of patients receive treatment and of those, only about half will be cured.

Bedaquiline, a component of the BPaZ regimen, has received provisional approval from several regulatory authorities around the world to treat people with drug-resistant TB when added to other effective drugs. A previous Phase 2 study found that bedaquiline, when added to other effective drugs in a standard MDR-TB regimen, has a better cure rate than placebo.

The trial announced today, NC-005, further explores the potential of a bedaquiline containing regimen to shorten and simplify TB therapy, eliminating the need for an injectable in eligible drug-resistant patients. In an earlier study called NC-003, the BPaZ regimen killed more than 99 percent of TB bacteria in sputum in two weeks, with no associated safety signals.

NC-005 will test BPaZ at 10 sites in South Africa, Tanzania, and Uganda and will include patients whose TB organisms are sensitive to the drugs in the regimen.

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About the TB Alliance

The Global Alliance for TB Drug Development (TB Alliance) is a not-for-profit organization dedicated to finding faster-acting and affordable drug regimens to fight tuberculosis (TB). Through innovative science and with partners around the globe, we aim to ensure equitable access to faster, better TB cures that will advance global health and prosperity. The TB Alliance operates with funding from Australia Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, European Commission, Global Health Innovative Technology Fund, Irish Aid, National Institute of Allergy and Infectious Disease, UNITAID, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration. For more information please visit tballiance.org.