New TB Drug Regimen Poised For Phase III Trial

Supported by funding from the Bill and Melinda Gates Foundation, TB Alliance is advancing the first ever drug regimen PaMZ intended to treat both drug-sensitive and certain forms of multi-drug resistant tuberculosis (TB) to a global Phase 3 clinical trial.

Bill Gates, co-chair of the Bill and Melinda Gates Foundation, accompanied the announcement with a call on other organizations to support new development efforts for tuberculosis. Mr. Gates said, “The results from early phase research suggest that this new drug regimen could provide the breakthrough we need to accelerate progress against this deadly and dangerous disease. PaMZ could reduce the time required to cure drug-resistant TB from two years to just six months, and it could cut the cost of curing drug-resistant TB in low-income countries …”

The TB drug regimen, known as PaMZ, will advance to Phase III testing based on positive results from earlier clinical studies. PaMZ has shown promise to significantly shorten therapy, in particular for certain forms of multi-drug resistant TB. The regimen will be tested for safety and efficacy in a Phase 3 clinical trial named STAND (Shortening Treatments by Advancing Novel Drugs). PaMZ is a three-drug regimen comprised of two candidate drugs not yet licensed for use against TB. These are PA-824 (Pa), moxifloxacin (M), and an existing antibiotic used in TB treatment, pyrazinamide (Z). Earlier study findings show the regimen's potential in the treatment of both drug-sensitive and drug-resistant patients with the same oral therapy. PaMZ also dramatically shortened treatment times for some patients.

Tuberculosis is a major cause of death worldwide, especially among people who are co-infected with HIV. TB is responsible for the deaths of approximately 1.3 million people every year.

If successful, PaMZ would eliminate the need for injectable drugs and reduce the cost of MDR-TB therapy in some countries by over 90 percent in patients whose TB organisms are sensitive to the three drugs. The regimen also shows potential for compatibility with commonly used HIV drugs, offering possible help to millions of people co-infected with TB/HIV.