A clinical TB treatment trial announced Wednesday will show if a regimen of two new TB drug candidates and one that is part of existing tuberculosis treatment can streamline, shorten and greatly reduce costs of treatment for the disease, including some drug-resistant strains, significantly improving the odds that more patients will complete treatment successfully. The regimen would eliminate the need for painful injections, be safe for people also on antiretroviral treatment for HIV, is projected to shorten the duration of treatment that now can take as a long as two years to complete to six months, and could slash the cost of treatment by as much as 90 percent. Set to span 50 study sites across Africa, Asia, Eastern Europe and Latin America, with funding from the Bill and Melinda Gates Foundation, planning for the global phase 3 trial follows promising results in earlier studies. Announcing the STAND trial (Shortening Treatments by Advancing Novel Drugs) of the regimen called PaMZ (after the regimen’s three drugs: PA-824, moxifloxacin and pyrazinamide, which is used now in first line treatment) Bill Gates called on other funders to assist in developing the regimen for worldwide use.
TB Alliance, which developed the regimen, characterizes the STAND trial as one that not only offers hope for improved treatment and treatment outcomes, but one representing a new scientific approach to developing new treatments by testing drugs together. It is an approach, according to TB Alliance that could cut the time needed to develop a new TB regimen by up to 75 percent.
At the same time, TB Alliance announced that it had granted exclusive license to Fosun Pharma in the People’s Republic of China, where an estimated 50,000 of the roughly million people a year to get sick with tuberculosis have drug resistant forms of the disease.