STAND trial will not re-open patient enrollment
NEW YORK (21 December, 2016)—TB Alliance announced, based on positive results from the Phase 2b NC-005 trial, that it will now plan a Phase 3 study to test the BPaMZ (bedaquiline + pretomanid + moxifloxacin + pyrazinamide) regimen. In light of these results, where the BPaMZ regimen appears to be much more promising compared to the PaMZ (pretomanid + moxifloxacin + pyrazinamide) regimen, the STAND trial testing the PaMZ regimen will not be reopened to new patients.
While both the BPaMZ and PaMZ regimens show the potential to improve treatment for tuberculosis (TB) compared with today’s standard therapies, the BPaMZ regimen could improve treatment for significantly more patients, including those with drug-sensitive TB and virtually all patients with multidrug-resistant TB. BPaMZ also appears to have greater potential than the PaMZ regimen to shorten the duration of therapy.
“The results of the NC-005 study have compelled TB Alliance to revise our clinical trial plans,” said Mel Spigelman, MD, President and CEO of TB Alliance. “Given our limited resources, we must always prioritize those programs with the greatest potential impact on the TB pandemic.”
The NC-005 results were received while there was an enrollment hold on the STAND trial. The enrollment hold delay closed the gap in the time it would take for the BPaMZ and PaMZ regimens to come to market. Given the similar timelines and the superior results of the BPaMZ regimen in Phase 2b, TB Alliance has taken the decision to focus on advancing the BPaMZ regimen.
Although the STAND trial will not re-open enrollment, we will continue to follow all patients as per the protocol. Of the 284 patients enrolled in the STAND trial, all have now completed treatment and six months of follow up. TB Alliance will continue to follow all the patients in the trial for two years as per the original study design. All of the associated data will be collected and analyzed, and findings from the trial will be made available.
About TB Alliance (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 (TB). 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’s Department of Foreign Affairs and Trade, Bill & Melinda Gates Foundation, European Commission, Germany’s Federal Ministry of Education and Research, Global Health Innovative Technology Fund, Irish Aid, Indonesia Health Fund, National Institute of Allergy and Infectious Disease, Netherlands Ministry of Foreign Affairs, UNITAID, United Kingdom Department for International Development, United States Agency for International Development, and the United States Food and Drug Administration.