The following is a guest post by Cherise Scott, secretariat of the Stop TB Partnership Working Group on New TB Drugs. This post is the first in a series of special commentaries and interviews in honor of World TB Day, which is this Thursday, March 24.
As we turn back and review the past year, it’s apparent just how significant the shift in strategy has been on the part of the TB research and development community in the search for new regimens 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 groundbreaking 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 created 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, which can reduce drug development timelines by as much as 75 percent.
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 six 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 – with sites at Karl Bremer Hospital and the University of Cape Town Lung Institute – should be available this year.
To further drive combination drug development for diseases like tuberculosis that require such drug regimens, the FDA is moving forward with the development of draft guidance “designed to encourage companies to work in tandem to develop two or more new drugs to be used in combination to treat cancer and infectious diseases, among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, Dr. Janet Woodcock and colleagues from the FDA wrote a New England Journal of Medicine perspectives piece 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 they were joining the More Medicines for Tuberculosis (MM4TB) campaign 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 more than one third of the global population, and represents 40 percent of all AIDS deaths. As we celebrate World TB Day March 24, we raise the voices of all those affected by TB to proclaim 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 ancient, deadly disease.