HomeWashington Letter2014 ▶ Landmark TB Clinical Drug Trial to Begin
Landmark TB Clinical Drug Trial to Begin

April 2014

This week, the Bill and Melinda Gates Foundation announced that it will help fund a phase 3 clinical trial of a promising new TB drug regimen for patients with both drug-sensitive TB and some forms of drug-resistant TB. The STAND (Shortening Treatments by Advancing Novel Drugs) trial, sponsored by public-private partnership TB Alliance, will determine the safety and efficacy of a shorter TB regimen combining a new TB drug known as PA-824 and two other TB drugs. PaMZ, as the combination is called, could reduce treatment for drug-resistant tuberculosis to six months from 24 months. If successful, the new regimen would eliminate the need for injectable drugs and reduce the cost of MDR-TB therapy in some countries by more than 90 percent in patients. The regimen is also expected to be compatible with HIV drugs, which will help the millions TB-HIV co-infection.

If successful, the new regimen would be the biggest advance in TB treatment in decades. TB Alliance must still secure some additional funding to begin the trial (estimated to cost $58 million) this year, which will be conducted in about 50 sites across Africa, Asia, Eastern Europe and Latin America. Trial results are expected in 2017. TB Alliance also announced this week that it has granted an exclusive license to Shanghai Fosun Pharmaceutical Development Co., Ltd. to develop and commercialize the PaMZ regimen in China.

Last Reviewed: October 2017