In the lead up to World TB Day, the Critical Path to TB Drug Regimens sponsored Cure All, a briefing on the most promising new TB drug research. Held at the Kaiser Family Foundation, the event featured a panel of senior representatives from a number of US government organizations, as well an announcement of a new regimen trial by the TB Alliance.
The event was moderated by Christine Lubinski, Vice President for Global Health, Infectious Diseases Society of America, who outlined the global burden of TB as well as some of the challenges facing TB research and development and the search for new TB cures.
The keynote address was given by Dr. Anthony Fauci, Director, National Institute of Allergy and Infectious Diseases (NIAID), NIH. Dr. Fauci explained the urgent need for new TB technologies and provided an overview of various research initiatives underway in TB pathogenesis, and drug, vaccine, and diagnostic development. In addition, Dr. Fauci stressed the commitment of NIAID, and the US government at large, to the promotion of TB R&D, referencing the availability of clinical trial sites from the US AIDS Clinical Trial Group (ACTG) to bolster the global capacity for TB research. ACTG is already running clinical trials in TB research, including a Phase III registration study known as REMox TB, which concluded enrollment earlier this year.
Dr. Janet Woodcock, Director, Center for Drug Evaluation and Research, Food and Drug Administration focused her presentation on the importance and progress of developing proper and rapid pathways for registration of new TB technologies. Streamlined regulatory pathways will help prevent bottlenecks at the conclusion of the research process and enable new life-saving health technologies to reach patients quickly.
Robert Clay, Deputy Assistant Administrator, Global Health Bureau, United States Agency for International Development (USAID) discussed USAID’s ability to facilitate the implementation of new TB technologies, as well as their commitment to fund late-stage TB drug research trials. He also discussed the importance of partnership—among federal agencies, but also with the private sector—particularly among a time of financial constraints. Speaking about efforts to fight TB, he said, “No one group can address this alone. … We’re going to have to be working together to grow the pie.”
Dr. Mel Spigelman, CEO and President, TB Alliance then announced the launch of NC-002, a new Phase IIb clinical trial testing a drug regimen with the potential to reduce the duration of treatment for both TB and some forms of MDR-TB to 4 months. The trial is the first to enroll both TB and MDR-TB patients simultaneously and treat them with the same regimen. The new regimen, which consists of PA-824, moxifloxacin, and pyrazinamide, has the potential to reduce the duration of MDR-TB by more than 80% and its cost by 90%.
The event concluded with a question and answer session, which included discussion on various issues relating to the most pressing challenges to TB research, specifics on the NC-002 trial, and the collaborations necessary to bring experimental regimens through development today.