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Médecins Sans Frontières Partners with TB Alliance in Three-Country Study

Study builds on promising results from TB Alliance’s late-stage trials

January 20, 2017

TB Alliance will provide pretomanid, a drug in the final stages of clinical development, as well as its drug development expertise as a partner on a clinical trial launched by Médecins Sans Frontières/ Doctors Without Borders (MSF). The study, TB PRACTECAL, a composite Phase II-III trial which will run in three countries, will examine the effectiveness of multiple regimens based on two new classes of tuberculosis (TB) drugs that TB Alliance has been testing in separate trials.

“We welcome this research partnership with MSF, as the current situation, especially for the treatment of drug-resistant TB, is untenable,” said Mel Spigelman, MD, CEO and President of TB Alliance. “This study will build on the promising results found in two of TB Alliance’s late-stage clinical trials, which have studied bedaquiline and pretomanid in combination with other drugs. Combining novel drugs holds the key to revolutionizing TB treatment in all its forms.”

Tuberculosis killed 1.8 million people in 2015, and requires a combination of powerful antibiotics for treatment. The bacteria that causes the disease is evolving, however, and many infections are now resistant to the first- and even second-line combination of drugs. Currently patients with drug-resistant TB are on medicine for 9 months to two years or more, during which time they must swallow more than 10,000 pills and have painful daily injections for at least 6 months. Of those who are able to access treatment, only half of patients with multi-drug resistant (MDR-) TB, and less than a third of patients with XDR-TB, are cured.

TB PRACTECAL will look at the effectiveness of three regimens in treating drug-resistant TB. These regimens are comprised of:

  • Bedaquiline, a novel TB drug approved in 2012 and developed by Janssen
  • Pretomanid, a drug in late-stage clinical trials being developed by TB Alliance
  • Linezolid, an existing antibiotic that has been used off-label to treat TB
  • Clofazamine, an existing antibiotic for leprosy that has been used off-label to treat TB
  • Moxifloxacin, an existing antibiotic that has been used off-label to treat TB and is in development as part of a novel regimen

TB Alliance has begun testing the combination of bedaquiline, pretomanid, and linezolid in its Nix-TB study, and will present interim results at the forthcoming Conference on Retroviruses and Opportunistic Infections (CROI) in Seattle.