What is the current strategy for developing new TB drugs?

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Answered by: Cherise, An Expert in the Respiratory Infection Category
As we turn back and review the last year, the TB research and development community experienced a significant shift in strategy in the search for new TB drugs to treat this scourge of mankind.

The idea of testing combinations of drug candidates to minimize delays in registering new TB regimens is finally gaining recognition and support. This ground-breaking approach was initially discussed in 2004 during a series of meetings hosted by the Working Group on New TB Drugs. Today we see these ideas manifest themselves through initiatives such as the Critical Path to TB Drug Regimens (CPTR) which was founded by the Bill & Melinda Gates Foundation, the Critical Path Institute, and the Global Alliance for TB Drug Development . CPTR works to streamline the registration pathway for novel TB drug combinations that can reduce drug development timelines by as much as 75 percent.



Video Illustrating how TB drug regimens were traditionally developed, and how regimens could be developed faster and more efficiently

http://player.vimeo.com/video/10288716

In November 2010, NC001, the first clinical trial of a novel multi-drug regimen, was launched with the potential to treat both drug-sensitive and multidrug-resistant tuberculosis (MDR-TB) in less than 6 months. This could be a revolutionary advance, given that treatment for MDR-TB treatment can take up to two years. Early results from this Phase IIb trial should be available this year.

To further drive combination drug development for diseases like tuberculosis that require drug regimens, the FDA is moving forward with the development of draft guidance “designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among other illnesses.” The final version is expected be released by June 2011. For further insight, Janet Woodcock and colleagues from the FDA wrote a perspectives piece in the February issue of the New England Journal of Medicine iterating the FDA’s commitment to the development of innovative combination therapies and to managing the risks involved in combination development programs.



Certainly, all this progress comes down to the promising TB drugs in the pipeline and the partnerships and people that are advancing the science. For example, last week, AstraZeneca and Sanofi-Aventis announced that it was joining the More Medicines for Tuberculosis (MM4TB) to advance early discovery and development of TB drugs. The MM4TB consortium fosters partnerships with some of Europe’s leading academic TB researchers and major pharmaceutical companies with the objective of discovering and validating new targets and compounds that can be developed as novel TB drugs.

Momentum is “full speed ahead” for bringing about the reduction and eventual elimination of the disease that claims almost 2 million lives a year, has infected over one third of the global population, and represents 40% of all AIDS deaths. As we celebrate World TB Day March 24, we raise the voices of all those affected by TB and proclaiming this is not the time to push this issue to the side. It is important that academics, governments, private companies, non-profit organizations, and patients strengthen their commitments so that we vanquish this most ancient of diseases, TB.

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