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Global Phase 3 “STAND” Trial Launched to Test New Tuberculosis Drug Regimen PaMZ to Shorten, Improve Treatment

* STAND trial will take place in approximately 50 study sites in Africa, Asia, Caribbean, Eastern Europe, and Latin America

* Results published in The Lancet show PaMZ’s promise to dramatically shorten and simplify therapy for patients with drug-resistant TB; Regimen could improve treatment for those with drug-sensitive TB and those with HIV co-infection

NEW YORK (March 18, 2015)—TB Alliance and its partners announced the launch of STAND, a global Phase 3 clinical trial of a drug regimen, which shows the potential to improve multi-drug resistant tuberculosis (MDR-TB) treatment by being dramatically shorter, simpler, safer, and affordable than current standard therapy. It also shows promise to improve treatment for those with drug-sensitive TB and those with TB/HIV co-infection. Results of an earlier study of the regimen were published today in The Lancet.

The STAND (Shortening Treatments by Advancing Novel Drugs) trial will include approximately 50 study sites across Africa, Asia, Caribbean, Eastern Europe, and Latin America.

TB kills an estimated 1.5 million people annually, and is one of the world’s most deadly diseases. Currently, people with MDR-TB require 18 to 24 months of treatment, with thousands of pills and daily injections for at least six months. According to the World Health Organization, of the 480,000 patients with MDR-TB in 2013, only 20 percent were treated. Of those treated, less than half (48 percent) of MDR-TB patients are cured. Even those with drug-sensitive TB require a minimum of six months of therapy, a significant burden for people with TB and the programs that care for them.

“Today’s TB treatment options are inadequate compared to the scale of the problem, and the inadequacies can overwhelm patients, families, and health systems,” said Mel Spigelman, MD, President and CEO of TB Alliance, the trial’s sponsor. “PaMZ is the first regimen designed to treat drug-sensitive and MDR-TB. As such, it could help ensure TB patients and healthcare providers have a more effective treatment option to help in scaling up the response to combatting the disease.”

The STAND trial will test PaMZ, a three-drug regimen comprised of two candidate drugs that are not yet licensed for use against TB—pretomanid (previously known as PA-824) and moxifloxacin—and one approved TB antibiotic, pyrazinamide.

The new therapy is promising for those patients with active TB and whose organisms are sensitive to the three drugs. This includes one-third to one-half of all MDR-TB cases as well as those classically defined as having drug-sensitive TB. Additionally, PaMZ shows promise to improve treatment for those patients co-infected with HIV.

“The PaMZ regimen would represent a major innovation in the fight against TB,” said Professor Stephen Gillespie, the Sir James Black Chair of Medicine at the University of St. Andrews and the principal investigator of the trial. “For MDR-TB patients, it would eliminate the need for injectable drugs and shorten therapy from years to a matter of 6 months. PaMZ’s compatibility with commonly used antiretroviral drugs is really important as TB is the largest killer of people with AIDS.”

STAND researchers expect to enroll 1500 patients in 15 countries across Africa (Kenya, South Africa, Tanzania, Uganda, Zambia), Asia (China, Malaysia, Philippines, Thailand), Caribbean (Haiti), Eastern Europe (Georgia, Russia, Ukraine), and Latin America (Brazil, Peru) in this study.

PaMZ will be tested in STAND as a 4- and 6-month treatment for drug-sensitive TB and a 6-month treatment for drug-resistant TB, and also enroll those co-infected with HIV. Each patient will be followed for two years starting from the beginning of treatment. The STAND trial partners with many of the communities in which the study is conducted through its robust community engagement program.

If successful in this Phase 3 trial, the PaMZ regimen would eliminate the need for injectable drugs and reduce the cost of MDR-TB therapy by more than 90 percent in those patients whose TB organisms are sensitive to the three drugs. It also promises to be compatible with commonly used HIV drugs, helping the millions of people co-infected with TB/HIV.

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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. 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. TB Alliance operates with support 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.