During the “Cure All: A briefing on the status of the most promising new TB drugs research” sponsored by the Critical Path to New TB Drug Regimens (CPTR) on Monday, March 19, Dr. Mel Spigelman, CEO & President, of TB Alliance announced the launch of the NC002 trial, a combination drug trial that establishes a new pathway to TB and multi-drug resistant TB treatment. Read full press release.
Overview of NC002 trial:
- Phase II trial assesses the 3-drug regimen PA-824, moxifloxacin, and pyranimide.
- This is the first trial to assess a regimen in both drug-sensitive and drug-resistant patients.
- 8 week trial will take place at 8 clinical research sites in Africa and South America.
- This is the next stage after promising results from NC001.
- Experimental regimen has the potential to reduce treatment to 4 months, this is a conservative estimate.
- The regimen could reduce costs for treatment for patients with drug-resistant TB by 90%.
- Experimental regimen is completely oral with no injectables.
- The drugs within the regimen have no known interactions and should be compatible with antiretrovirals.
The meeting involved high-level officials from U.S. agencies that support TB research including Anthony Fauci (Director, NIAID/NIH), Janet Woodcock (Director, CDER/FDA), and Robert Clay (Deputy Assistant Administrator, Global Health Bureau/USAID). There were over 70 attendees from global health advocates to members of the press. Here are some highlights from the meeting:
- Dr. Fauci discussed the state of science around TB research emphasizing the gaps in knowledge and tools for diagnostics, pathogenesis, treatment, and prevention of TB. This lag in TB research and funding has been a consequence of complacency in TB control as rates begin to decrease in the 80′s and 90′s in the U.S. The emergence of HIV/AIDS and the discovery the synergistic relationship with TB has resulted in renewed interest and progress in TB research and control. NIAID has doubled its funding for TB research since 1998 and even as NIH budgets flatlined after 2003, funding for TB has continued to increase.
- Dr. Woodcock talked of the need for a clear pathway for testing TB drugs and the need for tools to better evaluate new regimens in development. The FDA has been working to support coalitions to bring this about as well as issuing a guidance addressing the development of combination treatments. Also, the FDA is supporting work to identify potential biomarkers for TB to help better assess treatment outcomes, and held a 2010 workshop and awarded grants on the topic. Other areas where the FDA has provided support is on identification of antigens of TB, invitro tests for TB vaccine development, organizing coalitions on data standardization for clinical trials with CDISC, and changing TB diagnostics to Class 2 from Class 3 enabling expedited movement through the regulatory pathway.
- Dr. Clay stressed the importance of partnerships and efficient investments in TB research saying that one group can not address the problem of TB alone. USAID is contributing to TB research by supporting the stage of TB research that has direct implication to countries and TB control efforts on the ground–end-stage clinical trials. An example of this is the USAID is supporting the STREAM study which is testing a 9-month MDR-TB treatment regimen.
For more information on the meeting and to see video, photos, and summaries, click here to visit CPTR Initiative’s website.